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MYOPRO PROCESS FOR OBTAINING A MYOPRO

 Typically, a telephone conversation is first done to


see if MyoPro might be right for you. Then a physical
ABSTRACT evaluation is done by a certified clinician. During the
 MyoPro is a powered arm and hand orthosis (brace), evaluation session, an Orthotist/Prosthetist will:
a myoelectric robotic arm or a wearable robotic o Discuss & demonstrate the MyoPro brace
device that enables a person with a weak or partially and provide education regarding aspects of
paralyzed arm to perform activities of daily living, use
such as feeding, reaching, and lifting and designed to o Ensure the MyoPro is clinically and
help restore function to the wearer ' s paralyzed or medically appropriate for the candidate by
weakened upper extremities, helping individuals testing upper limb muscle strength and
perform ADLs. The MyoPro also facilitate ROM
rehabilitation including muscle re-education and o Discuss insurance benefits, coverage and
increasing ROM potential cost
 It is intended to be a ' neuro prosthesis ' meaning that o Complete all necessary evaluation
after developing proficiency the Myopro user is able paperwork
to complete functional tasks while wearing the o Discuss the role and importance of physical
orthosis that they could not do without it. therapy for new MyoPro users
 It is therefore available for purchase as a bespoke o When you pass the evaluation, and if you
item for home use intend to use insurance, certain paperwork
must be completed and then Myomo files
HISTORY OF MYOELECTRIC DEVICES/DATE OF for pre-approval with your insurance
INTERVENTION company. If you intend to use VA,
 The technology has, over the past 50 years, moved Myomowill help guide you through that
from single muscle control of a single prosthesis process
function to more complex muscle group activity o The insurance approval process may take
control of multifunction prostheses. Central to these months, depending on your carrier. After
changes have been developments in the means of approval, you visit a Myomo qualified
extracting information from the myoelectric signal Orthotics and Prosthetics practice to have a
 By supporting research in 1990, the VA promoted and cast taken of your arm so that we may
inspired development for a future myoelectric custom-fit the MyoPro
orthosis that could be of benefit to Veterans that have o A couple of weeks later the finished custom
upper extremity impairment. In 2006, work in device is ready for you. The MyoPro device
myoelectric upper extremity orthoses at MIT was will be calibrated to the user ' s individual
commercialized resulting in the development of the muscle signal profile and minor adjustments
MyoPro myoelectric elbow-wrist-hand orthosis to the MyoPro can be made to optimize
(EWHO) comfort
INDICATION
MYOPRO  Allows a user with arm or hand paralysis to
 Is a powered brace for your elbows, hands, wrists, experience movement in the time it takes to put it
that help restore function to an arm and hand on
weakened or paralyzed by stroke, brachial plexus  It is the only device available that can immediately
injury or other neuromuscular disease or injury enable movement of a paralyzed hand and arm
 Helps restore an individual’ s ability to perform ADLs,  Training by an occupational & physical therapist is
including eating a meal, lifting and carrying objects required to achieve competence with the device
and performing household tasks. Many can return to  Everyday tasks such as feeding and dressing may
work, live independently and reduce their overall cost now be done again
of care  Adolescents (ages 12+), adults (ages 18+), Veterans,
with neuromuscular conditions and injuries including
but not limited to
o Brachial Plexus Injury
o Spinal Cord Injury
o Cerebral Palsy
o CVA (stroke)

CONTRAINDICATIONS
 Insufficient myoelectric signal output from at least (fully non-invasive, with no implants) then activating
one muscle group needed to activate the desired small motors to move the limb as the user intends
powered joint (no electrical stimulation). The user is completely
 Severe shoulder subluxation controlling their own hand, wrist, elbow, and arm;
 Excessive pain in shoulder, arm or hand during the robotic arm brace amplifies weak muscle signals
facilitated range of motion to help move the upper limb. It has been called "
 Contraindicated during recovery from acute injury power steering for your arm "
such as trauma, infection, or skin condition
 Upper extremity contracture that prevent functional RESULTS
movement to benefit from the orthosis
 Rigid spasticity in the affected muscle groups
 Arm circumferences and lengths that are outside
build specifications required to be fit with the
orthosis
 Cognitive or behavioral impairment that would
inhibit safe use of the orthosis
 Other medical issue which interferes with safe use of
the device for functional improvement

ADVANTAGES
 The MyoPro also has potential as a rehabilitation
tool as following intensive use of the device, it has
been found that movement and function of an
impaired arm can be improved when the device is
not worn. The therapeutic benefits have been shown
to include
 Increased ROM  There is a significant, historically-unmet need for
 Increased Strength restorative, powered bracing in the patient
 Decreased tone/spasticity population suffering from upper extremity weakness
 Decreased muscle co-contractions secondary to neurological injury
 Improved selective muscle control  Powered, myoelectric technology has been used
 Decreased compensatory movements since the 1950s
 Covered insurance companies, Medicare Advantage  Since then, numerous clinical trials have repeatedly
plans, and the U.S. Veterans Administration demonstrated that powered orthotic devices are in
 Customized according to the need of the patients fact highly effective
 Helps arranged physical therapy with MyoPro  Economic analyses show that even with the initially
System higher upfront costs, using powered orthoses results
in long term cost savings
DISADVANTAGES  Therefore, FDA-approved, myoelectrically powered
 Expensive especially if not covered by insurance orthoses, commercially available today have in fact
 Need extensive training with the use of MyoPro been thoroughly vetted by the scientific and clinical
 Heavy Weight communities
 Extended Therapy Time for Training  A growing number of specialized treatment centers
 High-Maintenance are including myoelectric orthotic restoration in their
 Not allowed with patients who cannot follow verbal rehab protocols
command
 Limited- only allowed in some states in the US SUMMARY / CONCLUSION
 MyoPro is a powered brace for your elbows, hands,
METHODS/STANDARD OPERATING PROCEDURE wrists, the only such device that may help restore
 MyoPro works by reading the faint nerve signals function to an arm and hand weakened or paralyzed
from the surface of the skin, without the need for by stroke, brachial plexus injury or other
implants or surgery, and activating small motors to neuromuscular disease or injury. In a group clinical
move the arm and hand as the user intends. The setting, it was feasible to implement a myoelectric
user wearing the brace is in complete control of their upper limb orthosis with patients with
own hand and arm, the device simply amplifies the neuromuscular conditions and injury. It uses
weak muscle signals to help move the limb electromyography (EMG) control software to
 The device works by reading the faint nerve signals continuously monitor and sense even very weak
(myoelectric signals) from the surface of the skin muscle signals
 Clinically important and statistically significant gains
were made on a measure of upper limb motor
control. Overall, MyoPro is the only wearable robotic
device on the market to help restore function for
those who still have their arms and hands but are
unable to use them
Robotic Rehabilitation: An Opportunity to Improve Cognitive Functions in Subjects With Stroke. An

Explorative Study

Group 3:

ALAMON

APOSTOL

BASANES

CRUZ

DINEROS

DUMAGO

HIPOLITO

ONGANON

The robotic set: Pablo (upper left), Amadeo (lower left), and Diego (lower right) from Tyromotion

and Motore (upper right) from Humanware.


Motore (Humanware) is a robotic device that allows passive, active, and active-assistive planar

movements of the shoulder and elbow joints. Amadeo (Tyromotion) is a robotic device that

allows passive, active, and active-assistive finger flexion and extension movements.

Pablo (Tyromotion) is a device based on a handle equipped with two sensors (a dynamometer

and an inertial measurement unit), able to record the movement of the hand in the space and

the forces applied to it but not to provide motorized assistance. The tasks require to perform

unimanual or bimanual three-dimensional movements of the shoulder, elbow, and wrist or to

apply forces to the handle; bimanual movement are performed through two additional tools,

namely, the multiboard and the multiball


Diego (Tyromotion) is a robotic system that allows three-dimensional, unimanual, and bimanual

movements of the shoulder joint, with arm weight support

Background: Up to three-quarters of acute and subacute stroke survivors experience cognitive

impairment following their stroke, which has a substantial influence on functional recovery,

quality of life, and social engagement. Robotic treatment has been demonstrated to help with

motor rehabilitation, but its impact on cognitive recovery has yet to be extensively examined.

Objective: The study will use a set of three robots and one sensor-based device for upper limb

rehabilitation to investigate the influence of a technology rehabilitation intervention on cognitive

skills in stroke patients.

Method: A total of 51 patients were enrolled in this pilot research. Three robots and one sensor-

based gadget were used in an upper limb rehabilitation program. The intervention consisted of

motor/cognitive activities that were specifically chosen from among those available to train

cognitive functions as well. Five days a week, patients went through 30 rehabilitation sessions,

each lasting 45 minutes. Several cognitive tests were administered to patients before and after

treatment.

Stroke frequently results in cognitive impairment. The reported percentages of patients with

cognitive impairment after stroke vary depending on numerous factors, including whether or not
recurrent strokes were included, the time of evaluation following stroke, dementia criteria, and

whether or not aphasic individuals were excluded. Up to three-quarters of acute and subacute

stroke survivors are thought to have cognitive impairment.After a stroke, cognitive impairment

might jeopardize functional recovery, quality of life, and social participation. Indeed, several

researchers found that cognitive impairment can have a negative impact on rehabilitation

strategies. and be a poor predictor of functional and motor results in stroke patients after upper

limb robotic therapy

Robotic therapy has been advocated as a potential strategy for upper-limb rehabilitation, with

the goal of increasing the amount and intensity of therapy while also standardizing it. According

to the most current meta-analysis, robotics can improve upper limb motor function and

muscular strength following stroke, with no significant differences in motor recovery when

compared to a similar amount of conventional therapy.

In terms of mechanical construction, level of support, and complexity of workouts, robotic and

technological gadgets can present a variety of options with varying levels of technology. Despite

the fact that the first devices were fairly basic in terms of rehabilitation scenarios and required

tasks, the implementation of new graphical interfaces and more ecological scenarios, as well as

more cognitively demanding tasks, can now allow patients to participate actively in both physical

and cognitive activities during robotic therapy.


Published: 19 November 2020.

Indication

 Determine an individual’s general thinking and reasoning abilities .

 It’s assess for language, memory ,numbers and praxis

 This is for attention and processing speed

Contraindication

Materials and Methods

In this study we recruited a group of people who had a single ischemic or hemorrhagic stroke

(verified by MRI or CT ) were between the ages of 35 and 85 had a stroke within the last 6

months , had cognitive abilities that were adequate to understand the experiments and follow

instructions (Token test corrected by age and school level 26.5) and had a upper limb

impairments (Fugl- Meyer Assessment score 58 ) in the previous 6 months .Patients with (a) a
history of recurrent strokes , (b) Behavioral and cognitive difficulties and / or impaired

compliance , (c) ankylosis (Modified Ashworth Scale equivalent to 4) and (d) severe visual acuity

deficits were excluded. This study was conducted following the International Conference on

Harmonization Good Clinical practice guidelines and the Declaration of Helsinki.All participants

gave written informed consent before study participation.

Assessment

Before the treatment, demographic , an aesthetic and clinical information was collected

(T0).Cognitive functions , upper limb performance and dependence in activities of daily living

were assessed at T0 and after the robotic rehabilitation intervention (T1)

Cognitive Assessment

As a cognitive screening tool, we used the Italian version of the Oxford Cognitive Screen (OCS)

recently developed with the specific aim to describe the cognitive deficits after stroke. The scale

consists of 10 tasks encompassing five cognitive domains: attention and executive function,

language, memory, number processing and praxis. In addition the Oxford Cognitive Screen is

particular techniques were used to investigate the impact of robotic rehabilitation on cognitive

skills .The cognitive test took about 90 minutes to complete ; in some cases, two sessions were

required to complete the tasks .Specifically , the test listed below were used.

1. Symbol Digit Modalities Test (Attention and Processing Speed )


- It is a test for overall neurocognitive and executive

functioning including attention, planning, and organizing in

addition to visual scanning and motor speed. In the first

row of the page the subject is shown 9 symbols that are

one -to-one associated with nine digits ranging from 1-9.

The rows below include simply symbols and respondents

are needed to report the digits associated with each

symbol orally in the following rows. In 90 seconds, the number of correct responses is

counted.

A higher score indicates higher cognitive functions

2. Digit Span Task (Memory)

- We utilize Hebb’s original Digit span forward

challenge as a guide (27). The examiner

pronounces a digit list at a pace of about one

digit per second and the students are asked to

repeat the list in the same sequence as the

examinee. If they are successful a one- digit-

longer list will be displayed. If they don’t

succeed, they’ll be given a second list of the same length. If subjects are successful on

the second list, a list one digit longer is given, as before. However, if subjects also fail on

the second list, the test is ended. The length of the digit sequences gradually increases,

starting with a sequence of three numbers (e.g., 5, 8, 2) to a sequence of a maximum of


nine items (e.g., 7, 1, 3, 9, 4, 2, 5, 6, 8). The span is established as the length of the

longest list correctly recalled (28).

3. Rey -Osterrieth Complex Figure (Visuospatial Abilities and Visual Memory)

- The task, originally designed by Rey (29) and later

standardized by Osterrieth (30), requires the subject

to copy a complex geometrical figure (immediate copy

condition) (29, 31). For the test, performance

accuracy was calculated by applying the standard

scoring criteria, in which the geometrical figure is

divided into 18 units and scored on a 2-point scale for

both accuracy and placement (32).

4. Tower of London (Executive Functions)

- It is a test used in applied clinical neuropsychology for

the assessment of executive functioning specifically to

detect deficits in planning. Which may occur due to a

variety of medical and neuropsychiatric conditions. It

is related to the classic problem solving puzzle known

as the Tower of Hanoi. In this study, three scores

were computed : points , time (measured as the sum of the planning and the execution

time ) and errors.


5. Stroop Color and Word Test (Executive Functions )

- It is a neuropsychological tool widely used in clinical practice to assess selective attention,

cognitive flexibility, and sensitivity to interference, abilities that have been linked to the

frontal lobes. 3) color–word (interference test)3 lists of 10 words ("red," "blue," "green"),

each written in black ink (red, blue, or green) are

given to the patients in random order; they must

read the written words; (2) color (color

designation)3 lists of 10 colored (red, blue,

green) circles are given to the patients in

random order; they must name the color of the

circles; and (3) color–word (interference test)3

lists of 10 words ("red," "blue). The time it took to complete each test (T1, T2, and T3), as

well as any faults that occurred, are noted. The time (difference between the average

time spent in the two previous tasks and the time spent in the third test) and error

(difference between the average time spent in the two previous tasks) are then

calculated and utilized as outcomes (difference between the number of errors made in

the third test and the average time spent in the two previous tasks)

Treatment
The patient was treated with a set of three robots which is the Motore, Amadeo and Diego and

one sensor -based device (without motors:Pablo). The treatment was performed daily for 45

minutes, 5 days a week for 30 sessions .

- Motore (Humanware) is a robotic device that

allows passive, active, and active-assistive planar

movements of the shoulder and elbow joints.

- Amadeo --(Tyromotion) is a robotic device that

allows passive, active, and active-assistive finger

flexion and extension movements.

- Pablo (Tyromotion) is a device based on a handle

equipped with two sensors (a dynamometer and

an inertial measurement unit), able to record

the movement of the hand in the space and the

forces applied to it but not to provide motorized assistance.

List motor/cognitive exercise performed with the devices


Results

One hundred patients were assessed for eligibility, 48 of whom were excluded because of the

inclusion criteria. Fifty-two patients were evaluated at T0 and received the allocated

intervention. Of those, one patient did not undergo the follow-up evaluation, and therefore, 51

patients were evaluated at T1 and considered for the analysis.

Figure # 3:

Table # 2 : Demographic and clinical characteristics of the analyzed sample (N=51)


Figure # 4: Percentage of patients obtaining

a pathological score in the Oxford Cognitive

Screen (OCS)in our sample before (To) and

after (T1) the rehabilitation treatment. The

asterisk indicates a statically significant

difference between To and T1 in our sample .

Figure # 5: the changes in cognitive functions, as

measured by the selected outcome measures, are

reported. A statistically significant improvement was

found in all the investigated domain: attention and

processing speed (Symbol Digit Modalities Test), memory (Digit Span score), visuospatial abilities

and visual memory (Rey–Osterrieth complex figure), and executive functions (Stroop errors and

time, Tower of London error and time). Only the sub score “points” of the Tower of London Test

did not significantly change.

Table 3: Motor and cognitive assessment scores before (To) and after the robotic treatkment

(T1) together with the p values of the Wilcoxon signed rank test (with values in bold indicating a

statistically significant difference between T0 and T1)


Discussion

Improvements in cognitive functions are among the top 10 research priorities relating to life

after stroke. Improving attention, also in the short term, is very important during motor and

functional rehabilitation program. High attention enables people to engage better the exercises

proposed with a high ability to cope with proposed tasks. Virtual reality can be a useful

treatment capable of stimulating cognitive abilities (amnesic-attentive functions and visuospatial

cognition), executive processes, and behavioral abilities in patients with neurological disorders.

The advantage of incorporating virtual reality into rehabilitative programs is to create a positive

learning experience that can also be fun and motivating for the patient. These virtual reality

programs, developed to increase the patient's engagement, can contain cognitive exercises, and

can be integrated into robotic devices designed for motor rehabilitation. A cognitive treatment is

crucial for the subjects in which cognitive and motor impairments are often present at the same

time, as stroke patients. Few studies explored the cognitive effects of a robotic rehabilitation

program. The limited transfer of upper limb motor improvement from rehabilitation to daily

activities could be due to the lack of attention toward the coexistent cognitive impairment. This

is the first pilot study in which cognitive training and upper limb motor rehabilitation are

combined thanks to the use of robotic and sensor-based devices on a sample of subacute stroke
patients. Patients significantly improved in spatial attention, episodic memory, and calculation

after robotic treatment. After upper limb robotic treatment, all the explored cognitive domains

significantly improved, in particular attention and processing speed, visuospatial abilities visual

memory, executive functions, and memory. This study shows preliminary but encouraging data

on the opportunity offered by robotic technology to combine motor and cognitive treatments.

The proposed approach can be a resource to a more efficient rehabilitation treatment because it

permits to treat at the same time two aspects often impaired in stroke patients; however, it is

important to consider that this approach is feasible only if some requirements are satisfied: (a)

the devices must include motor exercises specifically designed to stimulate cognitive functions

(as visual memory, processing speed, etc.) and (b) the presence of a multidisciplinary team,

made of neuropsychologists, physiatrists, physiotherapists, and speech therapists, with expertise

in robotic rehabilitation, working synergistically on a new vision for the robotic rehabilitation.

The main limitation of this study is the lack of a control group, and therefore the results must be

considered as a starting point. It is not possible to exclude that the cognitive functions here

explored have improved spontaneously or because of the conventional rehabilitation.

Unfortunately, we did not find similar studies using the other cognitive tools proposed in our

study to compare our results with.

Conclusion

This explorative study suggests that robotic technology can be used to combine motor and

cognitive exercises in a unique treatment session.


Summary

Cognitive dysfunctions are common consequences of stroke and can significantly compromise

functional recovery, quality of life, and social engagement after a stroke. It is estimated that up

to three-quarters of acute and subacute stroke survivors exhibit cognitive impairment. Some

authors have shown that the impairment of the cognitive functions can negatively influence

rehabilitation strategies in patients with stroke. Robotic therapy has been proposed as a viable

approach for the rehabilitation of the upper limb. Meta-analysis suggests that robotics can

improve upper limb motor function and muscle strength after stroke. When compared to a

similar amount of conventional therapy, no significant differences in terms of motor recovery are

detected. The efficacy of robotics in restoring cognitive deficits was never explored. Robotic and

technological devices can present a variety of solutions with different levels of technology. New

graphical interfaces and more ecological scenarios, as well as more cognitively demanding tasks,

can allow an active physical and cognitive engagement of patients during robotic therapy.

Therefore, we hypothesized that a robotic treatment, based on the execution of exercises,

specifically selected, based on concurrent motor/cognitive tasks can improve cognitive deficits

beyond motor function in patients with stroke. The current study is an explorative study aimed

to evaluate the effects of upper limb robotic rehabilitation training on the cognitive functions of

subacute stroke patients.


Reference

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A ROBOT-BASED GAIT TRAINING THERAPY FOR PAEDIATRIC POPULATION WITH CEREBRAL

PALSY: GOAL SETTING, PROPOSAL AND PRELIMINARY CLINICAL IMPLEMENTATION

Group 3

Angel Hope Dumago

Bea Alcantara Onganon

Bliss Lorraine Alamon

Ira May Apostol

Nessy Dineros

Bianca Nicole Cruz

Rayniel John Hipolito

Sheann Basañes

Abstract

The use of robotic trainers has increased with the aim of improving gait function in patients

with limitations. Nevertheless, there is an absence of studies that deeply describe detailed
guidelines of how to correctly implement robot-based treatments for gait rehabilitation. This

contribution proposes an accurate robot-based training program for gait rehabilitation of the

paediatric population with Cerebral Palsy (CP).

The program is focused on the achievement of some specifications defined by the International

Classification of Functioning, Disability and Health framework, Children and Youth version

(ICF-CY). It is framed on 16 non-consecutive sessions where motor control, strength and power

exercises of lower limbs are performed in parallel with a postural control strategy. A clinical

evaluation with four paediatric patients with CP using the CPWalker robotic platform is

presented.

The preliminary evaluation with patients with CP shows improvements in several aspects as

strength, mean velocity, step length or gait performance.

The improvements achieved in the short term show the importance of working strength and

power functions meanwhile over-ground training with postural control. This research could

serve as preliminary support for future clinical implementations in any robotic device.

Date of Invention and Application

The study was carried out with the number R-0032/12 from the Local Ethical Committee of the

Hospital Infantil Niño Jesús. Public trial registered on March 23, 2017: ISRCTN18254257.

Indications and Contraindications

Indications:

1) Individuals with acquired brain injury, including traumatic brain injury and stroke

2) Individuals with spinal cord injuries at levels T4 to L5

3) Individuals with spinal cord injuries at levels of C7 to T3


4) to improve walking function and independence in patients with a neurological or muscular

injury, illness, or weakness.

5) to help facilitate the restoration or improvement of ambulation for its pilots. The device is

intended to serve multiple pilots over the duration of its life.

6) to manipulate the legs of a patient and move them through the normal walking gait, from the

sit-to-stand position and from standing back to sitting.

Contraindications:

There are no contraindications.

Advantages and Disadvantages

​Advantages:

1) Dropping Prices

2) The Power

3) Configuration

4) Lower Workplace Injury Rates

Disadvantages:

1) The cost

2) Limited Power Range

3) Limited Motion Range

Methods

Rehabilitation device
The CPWalker rehabilitation platform is a robotic device composed of an exoskeleton linked to a

walker that provides support and balance to the child during over-ground training. The device is

able to implement users’ PBWS and allows the adaptation of exercises to the patient’s

capabilities by means of individual controllers for each joint, which increases the modularity of

the system. Each joint of the CPWalker exoskeleton can operate in a wide range of modes.

i. Position control mode: in this mode, the robot imposes a

prescribed gait pattern to the user’s lower limbs. The aim

is that the patient learns the walking motion sequence

correctly.

ii. Impedance control modes: these modes take into account

the patients’ collaboration. Therefore, the prescribed gait

pattern should be achieved by the sum of robotic

assistance and patient’s cooperation. Three different

modes of impedance may be executed in CPWalker (high,

medium and low), which tolerate variable deviations from

the programmed gait trajectories, enhancing the patients’

participation and taking advantage of their residual

movements through assist as needed strategies (AAN).

iii. Zero-force control mode: in this mode, the trajectory reference is not given, and the

patient is who entirely moves the legs with a minimal resistance of the exoskeleton. It is

used with patients with enough motor control (acquired with the previous modes) but
poor balance, so the CPWalker provides stability and PBWS while the patient

implements the gait pattern.

Within each mode, some variables of the robotic platform are updated along the treatment

sessions: PBWS, gait velocity and the percentage of the total range of motion (ROM) [9]. The

possibility of varying these parameters enables the customization of the therapy to the

progression of each patient and gives a higher versatility for the treatment design. Additionally,

the robotic platform also includes a biofeedback strategy to motivate the children to actively

correct their posture during walking. The CPWalker robotic platform may be easily controlled by

a clinician through an intuitive interface, which controls and monitors the exercises in real time.

The variety of control modes, the number of adjustable parameters, the ease of setting the

variables individually for each joint and the possibility of implementing different strategies

associated with gait simultaneously, made CPWalker an appropriate platform for testing the

robotic therapy proposed in this manuscript.

Robotic training program


In order to define the objectives of the robot-based treatment, we adopted the conceptual

framework of ICF-CY. The proposal was focused on improving the principal gait-related functions

derived from this international classification. Concretely, the selected goals of the ICF-CY to be

achieved with the treatment and the work methodology implemented in the robotic device (in

this case CPWalker), are presented in Table 1.

TABLE 1

ICF-CY functional Implementation on CPWalker

domain

Mobility and stability The different control modes of the exoskeleton are used to guide the

of joint functions movement of a single or multiple joints, improving motor control. The

(b710, b715) exoskeleton also helps to maintain stability through the coordinated

actions of surrounding tissues. This domain is exercised along the

whole treatment with diverse robotic assistance.

Muscle power The second phase of the training requires the patient to contract a

functions (b730) muscle or muscle groups to generate the necessary force in order to

start and maintain the movement with AAN strategies. The force must

be maintained for a time in the extremes of the gait pattern

(maximum flexion and extension) in order to reach these maximum

values in the complete range of motion.

Muscle endurance Muscle endurance is exercised when the patient is requested to

functions (b740) sustain a muscle contraction to finalise the required movement with
AAN strategies, mainly in the extremes of the gait pattern (maximum

flexion and extension).

Control of voluntary The voluntary movement is implemented through the control and

movement functions coordination of simple and complex movements to collaborate with

(b760) AAN strategies. Lower impedance implies more patient’s control.

Gait pattern Motor control and gait pattern functions are trained through the

functions (b770) different control modes to guide the lower limbs following prescribed

gait patterns at several velocities and supports.

Maintaining a body A biofeedback strategy for postural control is used to notify the

position (d415) patients when they lose the correct position of the upper body. See

section “Postural control”.

Walking (d450) Overground walking training is executed in all sessions with controlled

PBWS, at different velocities and supports.

Proprioceptive During random moments of the first training session, the patients

functions (b260) perceive feeling using a mask on the eyes at the same time as the

robot performs the movement for single or multiple joints with 100%

of PBWS.

Formal relationships Creating and maintaining patient-researcher relationships. See section

(d740) “Motivation and inclusion of challenges”.

To achieve the goals presented in Table 1, we previously performed a systematic selection of

variables based on the requirements of the National Strength and Conditioning Association

(NSCA) youth training guidelines, which suggests that eccentric and explosive strength exercises
should be the beginning of a proper training to ensure greater muscle power generation and

the transference of gains to gait.

TABLE 2

Adapted youth resistance training NSCA guidelines

Variables Strength Power

Muscle actions Eccentric / Concentric

Exercise Single / Multi-joint

Intensity Load /

Velocity

According to the proposed objectives and complying with the NSCA youth training guidelines,

the treatment was conceptualised into two main phases, where the ROM, PBWS and gait

velocity were the principal parameters under variation. The intention was that the patient

maximised the gains acquired in the whole rehabilitation period (ideally the sum of robot-based

exercises and common non-robotic therapy). A detailed description of each phase follows:

I. First phase: the main aim of this phase was to improve motor control, teaching the

patients the correct sequence of motion and

increasing strength. The patients were

requested to follow the movements

established by the exoskeleton with the

minimal possible resistance during swing

period, pushing the ground at each step and


trying to keep the maximum flexion-extension values at the end of each gait cycle.

Instructions were given to ensure the comprehension of normative gait patterns, and

verbal encouragement in addition to direct feedback by graphics in real-time was

delivered throughout the sessions.

II. Second phase: the main aim of this phase was to further train motor control and

increase power in order to ensure the transference to the independent gait pattern.

Aware of the sequence of movement of a normal gait pattern, the patient’s contribution

became an important aspect to develop neuroplasticity and preserve the gained motor

control [15]. The active participation was achieved both by boosting the patient’s

motivation and by requiring self-activity [16]. The latter was implemented through AAN

algorithms and the impedance control modes presented previously for CPWalker.

Duration of the study

The robot-aided treatment was proposed for a whole period of 2 monthly cycles (1 month for

each phase of the treatment) with the aim of having enough sessions to generate significant

neural changes. The children trained 2 non-consecutive days per week for 8 weeks. The sessions

consisted of a 10–15 min warm-up and 60 min of over-ground exercise with CPWalker, including

3 min of independent gait as a cool-down phase.

The first 8 sessions corresponded with general motor control and strength exercises, where the

robot imposed a gait trajectory tracking. Sessions 9 to 16 were related to muscle power

performance through levels of AAN strategies, where self-activity was required.

Training phases
In order to individually define the training progression through the different sessions and to

comply with the NSCA guidelines, the principal modifications were implemented on ROM,

PBWS and gait velocity. This selection was concluded in collaboration with our clinical partners,

based on the evaluation of previous studies carried out with CPWalker. The robot-based tasks

began with high assistance and PBWS, and they progressed toward greater ROM and smaller

PBWS as long as the patient overcame the different levels of the sessions. Parameter variations

within and between sessions were performed as long as session goals were attained and when

the clinical staff agreed, based on levels of spasticity, fatigue and motor control presented in the

last day. If the patient was not ready to jump to the next challenge, the session was repeated

with the same last percentages.

Figure 3 Figure 4
Within the first phase, the first session was performed with the children completely suspended

(100% of PBWS) in order to adapt the users to the movements with the robot. Moreover, during

random moments of this first session, the patients wore a mask on their eyes to feel the motion

performance. For the rest of the first phase children’s lower limbs were guided through a pure

position control imposed by the CPWalker platform, with a gradual decrease in PBWS (Fig. 3

blue), and a gradual amplification of ROM (Fig. 3 light-grey). Gait velocity during this first phase

was maintained around a regular and small value (Fig. 3 dark-grey). Notice that in general, only

one variable at each session was varied.

The second phase of the training (sessions 9 to 16 in Fig. 4) presented an additional difficulty

that enhanced the user’s collaboration in the exercises performance through different levels of

AAN strategies in the exoskeleton. The initial ROM for the second phase was set at 80% of the

total gait pattern and reached 100% by session 13 (Fig. 4 light-grey), time at which velocity was

highly increased (Fig. 4 dark-grey). Note that gait velocity for this phase became around double

of the one achieved in the first phase, which is in relation to the requisites exposed in Table 2.

Furthermore, PBWS declined up to 30% of weight supported by the platform (Fig. 4 blue).

It is important to highlight in Figs. 3 and 4 that the percentage of PBWS was related to the

individual patient’s total weight, and the percentage of ROM was applied to the total trajectory

of the gait pattern programmed in the control of CPWalker. The estimated changes in gait

velocity are represented regarding percentages of CPWalker platform, where 100%

corresponded to 0.6 m/s.

Postural control
It was important to ensure that throughout all the sessions, patients maintained a proper

posture of head and trunk because it facilitates the performance of any activity of daily living,

and improves the social interaction, the participation and communication. In this sense, the aim

of our proposal was to provide biofeedback to the patients each time that they kept an

incorrect position of the body during walking. With this goal, the CPWalker robot used Inertial

Measurement Units (IMUs) (Technaid, Spain) to measure the rotation of head and trunk in real

time, and give acoustic feedback when subjects overcame predefined maximum values selected

by clinicians. In response to the acoustic feedback, patients were instructed to correct their

position, time at which the acoustic feedback ceased. This strategy had been previously proved

with promising results in children with spastic diplegia.

Metrics

In order to objectively measure the patient’s evolution and due to the lack of homogeneity

among children with CP, we decided to evaluate the progression of the therapy by comparing

each patient to himself, instead of maintaining a control group. We carried out some analyses

and evaluation metrics on different occasions of the study: during the use of the robot, before

the treatment begins (pre), in the middle and after the whole session (post).
The 10mwt was assessed for two situations: normal comfortable walking speed and maximum

walking speed. Three trials were collected for each situation and subsequently, the average of

the three trials was calculated.

Regarding the 6mwt, it was performed indoors along a flat corridor, where the walking course

had a 30 m length and was marked every 3 m. The turnaround points were marked with cones.

The patients received information about remaining time every minute, but they were not

encouraged during the exercise. The heart rate was also measured for each patient in two

situations: resting and just after finishing the test. This parameter gives the possibility of

calculating the Physiological Cost Index (PCI) after the exercise, which is used to quantify the

energy expended by the patients during the exercise and their progression. 3D gait analysis was

recorded at 200 Hz using a motion capture system Smart-DX (BTS Bioengineering, Italy). In order

to obtain gait kinetics, a set of reflective markers were placed over the skin on discrete

anatomical sites according to the Helen Hayes Model. Subjects walked barefoot at a

self-selected speed.

Maximum isometric strength was measured in kgf with a hand-held dynamometer microFET2

(Hoggan Scientific LLC, USA). Three records were taken and averaged for each movement

bilaterally (dorsiflexion, plantarflexion, knee flexion-extension, hip flexion-extension, abduction

and adduction).

The particularity of the SCALE assessment was that it was evaluated by the same

physiotherapist bilaterally on three occasions (pre, middle and post), with the aim of reducing

the subjective error.


The changes of GMFM-88were collected for the 88 items, but we focused on dimensions D

(standing) and E (walking).

The kinesiophobia assessment consisted of a test composed of 10 questions of 1 to 4 points

each. The responses were given by the patients without parents’ influence.

Two FAQ questionnaires were requested: one as initial questionnaire at the beginning and the

other as follow up at the end of the treatment. These surveys presented several questions for

parents and others referred to children.

During the whole treatment, ROM performance and force interactions were measured for each

session in order to evaluate if the patient was prepared to jump to the next stage with more

difficult parameters and level of assistance.

Finally, the users’ motivation was subjectively evaluated by the practitioner from 0 to 10 points

for each session with the robot.

Result

The preliminary evaluation with patients with CP shows improvements in several aspects as

strength (74.03 ± 40.20%), mean velocity (21.46 ± 33.79%), step length (17.95 ± 20.45%) or gait

performance (e.g. 66 ± 63.54% in Gross Motor Function Measure-88 items, E and D

dimensions).

Conclusions

The main aim of this research was to provide a first approach to the implementation of a novel

and defined robotic rehabilitation method that could cover the most important clinical aspects
of the ICF-CY framework. This proposal was tested with four paediatric patients with CP, which

they provided some preliminary outcomes to assess it. Although the patients’ progression was

evaluated without a control group, they do not consider it as a relevant limitation of the study,

since the wide variety of differences among each child with CP makes it interesting and even

necessary to expose the improvements by comparing each patient with himself. The most

challenging part was the second phase of the training, which allowed the possibility of adapting

the level of assistance depending on the patient’s progression. Thereby, any subject could

achieve the last level (level 6), and although the action of reaching level 4 took P3 longer than

the rest of children, this patient could pass through it in the last three sessions. It is interesting

to highlight that the outcomes from isometric strength measures showed important peaks of

improvement, especially for hip and knee flexion-extension, which was targeted with the

CPWalker robotic platform. These higher values were observed from the middle to the post

analysis. The results of the present study are difficult to compare with the scientific literature

due to the lack of studies using exoskeletons for gait resistance training. However, we can

establish that our results are in line with previous studies assessing conventional resistance

strength training in CP. Finally, the motivation scale for the patients and the parents’ satisfaction

with the robot-based treatment was very high in most aspects.

Reference:

​https://jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-018-0412-9

https://archdesk.com/blog/the-pros-and-cons-of-using-exoskeletons/

https://eksobionics.com/indications-for-use/
REX – ROBOTIC EXOSKELETON
Group 4: Bionic Solution

Cofreros, Regil

Diaz, Julienne

Sindol, Seychelle

Dionio, Lea Denise

Meriveles, Izra Joy

Gumayan, Patrick

Bayona, Ranel

Torrato, Arvin
REX – Robotic Exoskeleton

INTRODUCTION

REX is used by physiotherapists for people with mobility impairments, in rehabilitation centers in

the US, the UK, the Middle East, Australia and New Zealand.

Rex Bionics is working with rehabilitation specialists to develop the practice of Robot-Assisted

Physiotherapy. REX lifts patients from a sitting position into a robot-supported standing position,

allowing them to take part in a set of supported walking and stretching exercises, designed by

specialist physiotherapists to help achieve rehabilitation goals (REXERCISES).

REX does not require the use of crutches, leaving the arms free for upper-body exercises and

activities of daily living; and allowing access for a wide range of patients.

Wheelchair users are at risk of developing numerous medical complications from extended

periods of sitting. By enabling them to spend more time standing, walking and exercising, REX

may offer significant health benefits. A programme of clinical trials is under way to evaluate

these potential benefits


DATE OF INVENTION & APPLICATION

REX BIONICS LIMITED filed its patent on September 23, 2021 and was approved on January 6,

2022. It was invented by Richard Little and Robert Alexander Irving. REX is a walker for use by a

mobility impaired disabled user. The walker supports the user while moving them through a set

of movements correlating to a walking motion. The walker includes an exoskeleton, a power

source in the form of a battery pack or other similar onboard power pack together with its

associated power supply cables, and a control system The exoskeleton includes a rigid pelvic

support member including a pelvic harness and a pair of leg structures Each of the leg structures

comprise an upper leg structural member, a lower leg structural member, a foot member, a

main hip actuator, a knee actuator and a main foot actuator.

INDICATION

• SCI

• Stroke

• Balance problems

• Gait problems

• Multiple Sclerosis
CONTRAINDICATION

• Impaired skin integrity, including but not limited to wounds or skin lesions where the REX

cuffs, pads and straps come in contact with the User.

• Musculoskeletal impairment which influences the fit of the REX or places the User at risk

of injury during full weight bearing or movement, i.e. severe contractures, recent

fractures or severe osteopenia.

• High risk of autonomic dysreflexia in response to standing or walking.

• Other contraindications to standing or walking.

• Any condition that would pose an unacceptable infection control risk.

• spasticity score > 3 on the Modified Ashworth scale in the lower extremities.

Extra Care should be taken with individuals who have:

• Lower limb musculoskeletal impairment; including but not limited to hypomobility,

hypermobility, joint deformities, contracture, or heterotopic ossification.

• Compromised cardiovascular function; including but not limited to significant cardiac

disease, orthostatic hypotension, peripheral vascular disease, or those that take blood

thinning medications.

• Impaired cognitive function which may impact the Users ability to operate the REX safely

under clinical guidance.

• Impaired cognitive function which may result in the user becoming agitated and restless

while in the device.


• Impaired cognitive function that means the User is unable to fully grasp what is required

of them during the use of REX resulting in the inability to give informed consent.

• A stoma bag or PEG feed in situ which could be negatively affected by REX’s support

structures and straps.

ADVANTAGES

• Stand alone

• Quick to get going

• Maneuverable – fully automated Forward, Backwards, Sideways, and Turning movements

• Widely accessible – people with severe disabilities are able to successfully use REX

• Workhorse – shares the physical demands of delivering therapy and reduce the strain on

therapist

DISADVANTAGES

• May pose risk to patients such as ankle swelling and fracture on distal tibia or calcaneus

during walking.

• Requires special measurements for custom fit to patient.

• Requires special adjustments for patients with SCI if there is leg length discrepancy, pelvis

obliquity, sever muscle wasting, or even highly sensitive skin.


• Requires 10 to 30 minutes to safely don before walking, thus limiting the allotted training

time set for each patient

• Not suited for SCI patients who are overweight or obese weighting more than 100

kilograms.

• Patients needs to attain 10-15 degrees hip extension, <10 knee extension in standing or

supine with ankle in neutral for patients to be able to use this product.

• Patient experiences pressure injuries when using this device

• Diminishes sensation and impairs peripheral circulation

• Expensive

STANDARD OPERATING PROCEDURE

• REX is a hands-free, self-supporting device that allows for mobilization without the use of

crutches or a walking frame to maintain stability. It can be used by those with minimal

upper extremity function.

• The User is supported securely within the device using a pelvic harness, and thigh and

calf cuffs.

• REX is designed for use in a clinical environment, under the supervision of a REXtrained

Clinician. It is sophisticated, yet simple to use and operate. REX can be easily adjusted to

suit a variety of Users.


• The User typically transfers into REX, with appropriate assistance, in a seated position.

Once aligned properly and strapped in, the User is passively moved by REX into standing

and walking positions.

• The User or Clinician controls REX with a 3-button keypad and joystick or T-bar. REX is

powered by an on-board rechargeable, interchangeable battery pack.

• The functionality of REX enables a User to perform the following mobility functions within

a controlled environment, on a flat, horizontal surface: Stand Sit Walk Turn Shuffle (Side-

Step) Backward-Step REXercises

• REX is adjusted by a REX-trained Clinician, working closely with the User, to ensure an

accurate alignment of the User’s limb dimensions to REX’s at the ankle, knee, and hip

joints. Adjustments are independent of each other, enabling individualized postural

support.
RESULT / DISCUSSIONS

Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury:

ambulation and functional exercise programs in the REX powered walking aid investigates the

feasibility, safety and acceptability of using the REX self-stabilizing robotic exoskeleton in people

with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the

completion of transfer into the REX device, competency in achieving autonomous control and

completion of upper body exercise in an upright position in the REX device. Safety is measured

by the occurrence of serious adverse events. Device acceptability is assessed with a user

questionnaire.

RAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort

study in people with SCI recruited from neurological rehabilitation centres in the United

Kingdom, Australia and New Zealand. This is the planned interim report of the first 20

participants. Each completed a transfer into the REX, were trained to achieve machine control

and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a

single first time session. The time to achieve each task as well as the amount of assistance

required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring

device acceptability, was completed.

All participants could transfer into the REX. The mean transfer time was 439 s. Nineteen

completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of

whom needed either no assistance or the help of just one therapist. Eighteen participants

completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one
therapist. The questionnaire demonstrated high levels of acceptability amongst users. There

were no Serious Adverse Events.

This first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use

the REX powered assisted walking device to ambulate and exercise in. Participants with

tetraplegia and paraplegia could walk and perform a functional exercise program when standing

needing only modest levels of assistance in most cases. User acceptability was high.

SUMMARY

Physiotherapists use REX to help persons with movement issues, and Rex Bionics is partnering

with rehabilitation specialists to develop the practice of Robot-Assisted Physiotherapy in

rehabilitation clinics. REX raises patients from a seated posture to a robot-assisted standing

position, allowing them to participate in a series of supported walking and stretching activities

devised by physiotherapists to aid in the achievement of rehabilitation goals. REX eliminates the

need for crutches, freeing up the arms for upper-body workouts and daily activities, and giving

access to a wide spectrum of patients. REX eliminates the need for crutches, freeing up the arms

for upper-body workouts and daily activities, and giving access to a wide spectrum of patients.

REFERENCES

• https://www.rexbionics.com/

• https://patents.justia.com/inventor/richard-little
• www.rexbionics.com/wp-content/uploads/2017/09/TF-04-v4.0-REX-Clinical-Assessment-

Guide.pdf

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477376/

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153133/
OSSUR -POWER KNEE

INTRODUCTION

The Power Knee is the world’s first motor-powered microprocessor knee

Active assistance powers flexion and extension to mimic concentric and eccentric muscle activity

Advanced sensors accurately detect the user’s movements and inform the microprocessor

where state-of-the-art algorithms enable the knee to respond to the user’s needs

A powerful motor provides consistent stance phase but also free swing phase

Delivering active extension when standing up, controlled resistance when descending, active

flexion and extension during walking and energy returning stance flexion, Power Knee facilitates

symmetrical weight distribution and natural gait

DATE OF INVENTION/ APPLICATION

Ossur – Power Knee filed its patent on August 31,2015 and was approved on December 19,

2017. A prosthetic knee for active users has a locking head generally parallel to a vertical axis of

the prosthetic knee, a chassis, and a plurality of links connecting the locking head to the chassis.

The knee includes a swing control mechanism having a flexion stop connected to the chassis and

arranged to control the flexion angle of the knee. The flexion stop extends outwardly from the

chassis and obliquely relative to the vertical axis. The knee has an audible feedback mechanism

for providing the user with information about the location of the knee. The knee may also have a

block lock forming a manually activated mechanism allowing load bearing in a flexed position.
INDICATION

The device is to be used exclusively for the exo-prosthetic fitting of amputations of the lower

limb.

• Unilateral transfemoral amputation

• Use of the device with bilateral transfemoral amputees and patients showing limited

residual limb control, such as unilateral hip-disarticulated amputees and lower extremity

dysmelia patients, is subject to a case-by-case assessment and advanced fitting

performed by a qualified Össur clinical specialist.

CONTRAINDICATION

• None known

ADVANTAGES

• Auto-adaptive real-time stance and swing control

• Energy returning stance flexion

• Active assistance in level-ground walking, step-over-step stair ascent and when standing

up

• Intuitive knee lock when standing, facilitating equal weight distribution

• 25-hour typical usage on a single battery

• Replaceable battery, can be charged in knee or separately


• Accompanying Össur Logic app for iOS devices provides simple practitioner setup and

adjustment

DISADVANTAGES

• Cost, which is $70,000 to $90,000 US (or even more) for a complete solution.

• Weight: at 2.7 kilograms, it is too heavy for some users.

• Noise: The Power Knee does make an unmistakable noise while moving;

• Length: at 37.5 centimeters, it is too long for people with longer residual limbs.

STANDARD OPERATING PROCEDURES

Using the Prosthesis

The device automatically adapts to activities such as walking, standing up, walking up stairs, and

more. It has several different states that the patient must learn to recognize and activate.

Standing

The device is in standing state by default and it will revert to standing state if it does not

recognize a movement pattern.

The device will provide support when the patient applies weight to the prosthesis. The knee will

release/swing freely when the prosthesis is unloaded/no weight is applied to it. The patient can

take small steps and turns in a natural and physiological way.


Walking on Level Ground

The device adapts to the patients walking speed and style. It will give adaptive support in stance

phase and powered extension and flexion in swing phase.

Sitting Down

The device automatically detects sitting down motion. The device will provide support while the

patient sits down. The patient can use this to distribute weight equally to both legs and control

how fast to sit down.

To sit down, the patient should:

1. Stand in front of a chair.

2. Take most of the weight off the prosthesis momentarily.

3. Put weight back on the prosthesis.

4. Within 3 seconds, lean slightly backwards and start flexing the knee. The knee will

provide support during knee flexion until seated.

5. The patient can now take the weight off the leg to release the knee and move the knee

freely while seated.

After a few seconds of sitting without moving the knee, the knee will enter standby. Standby

turns off the motor to save power.

To exit standby, flex or extend the knee slightly


Standing Up

The device will recognize when the patient starts to stand up. The device will provide a powered

extension to let the patient apply equal weight to both legs.

To stand up, the patient should:

1. Make sure the prosthetic foot is underneath knee.

2. Put equal weight on both feet.

3. Start to stand up. The patient will feel the knee assist standing up naturally.

NOTE: If the patient is unable to apply enough weight to the prosthesis to get the knee to assist

with standing up, the patient can increase weight by momentarily pressing on top of the knee by

hand.

Walking Up Stairs

The device will provide powered knee extension when it detects stair ascent.

Initial training:

1. Stop in front of the first step of the stairs.

2. Flex the hip to lift the prosthesis off the ground. The knee will swing freely.

3. If needed, swing the leg outwards to get the leg onto the first step to prevent the toe

from catching the step.

4. Put the prosthetic foot flat onto the first step.

5. Put weight on the prosthesis and extend the knee fully. The knee will detect the stairs

and will provide powered extension.


6. When the knee has fully extended, place the other foot on the same step.

7. Take the weight off the prosthesis and if stair ascent has been triggered, the knee will

flex.

8. After a brief pause the knee will automatically extend.

9. Practice going up and down the first step, repeating the above steps, until the patient is

familiar with the knee action

To walk upstairs, the patient should:

1. Stop in front of the first step of the stairs.

2. Flex the hip to lift the prosthesis off the ground. The knee will swing freely.

3. If needed, swing the leg outwards to get the leg onto the first step to prevent the toe

from catching the step.

4. Put the prosthetic foot flat onto the first step.

5. Put weight on the prosthesis and extend the knee fully. The knee will detect the stairs

and will provide powered extension.

6. When the prosthetic knee has fully extended, place the other foot on the step above.

7. Flex the hip on the prosthetic side to bring the prosthesis to the next step. The prosthesis

will provide knee flexion to provide clearance and to prepare for the next step.

8. Continue climbing the stairs, with a step overstep pattern.

9. At the top of the stairs:

a. a. If prosthetic foot is leading, place the other foot next to it, and keep equal

weight on both feet for 3 seconds before continuing.


b. b. If the other foot is leading, flex the hip to place the prosthetic knee slightly in

front of the other knee until the prosthetic knee extends.

Walking Downstairs and Ramps

The knee will give support while it flexes when walking downstairs and ramps.

To walk downstairs or ramps, the patient should:

1. Take the first step down with the prosthesis.

2. Put weight on the prosthesis. Lean slightly backwards to flex the knee. The knee will flex

and give support.

3. Lower the other foot onto the next step or ramp.

4. Continue to walk down the stairs or ramp. The knee will adapt the support to the walking

speed. Tell the patient to put half of the foot onto the lower step for constant support

when walking downstairs.

Walking Up Ramps

Walking up ramps requires no change from level ground walking.

Standing Lock

Standing lock lets the patient stand with the knee locked at up to 30° angles. The patient can

lean against objects or stand comfortably with the knee slightly bent. In standing lock, the knee

will not flex but it can be extended.

To enter standing lock, the patient should:


1. Remove weight from the prosthesis.

2. Flex the knee to the desired position, up to 30°.

3. Put some weight on the prosthesis and hold it in position for a second.

4. Transfer full weight to the prosthesis. The knee will lock and give support.

To exit standing lock, the patient should:

1. Take weight off the prosthesis. The device will return to standing state.

Kneeling

The device automatically detects kneeling motion. The device will provide support until the knee

reaches the ground.

To kneel, the patient should:

1. Take a step forward with the sound leg. If needed, use a hand support to maintain

balance.

2. Take most of the weight off the prosthesis momentarily.

3. Put weight on the prosthesis.

4. Within 3 seconds, slightly flex the hip on the prosthetic side and hold pressure until the

knee starts to flex.

5. Kneel. The device gives support while kneeling.

Driving

When driving a vehicle, the device must be turned off.


RESULTS

Research entitled “Effects of extended power knee prosthesis stance time via visual feedback on

gait symmetry of individuals with unilateral amputation” shows a result that Increasing the

amputated-limb stance time via visual feedback significantly improved the stance time symmetry

(p=0.012) and peak propulsion symmetry (p=0.036) of individuals walking with both prostheses.

With the powered knee prosthesis, the highest feedback target elicited 36% improvement in

stance time symmetry, 22% increase in prosthesis-side peak propulsion, and 47% improvement

in peak propulsion symmetry compared to a no feedback condition. The changes with feedback

were not different with the passive prosthesis, and the main effects of device/ prosthesis type

were not statistically different. However, subject by device interactions were significant,

indicating individuals did not respond consistently with each device (e.g. prosthesis-side

propulsion remained comparable to or was greater with the powered versus passive prosthesis

for different subjects). Overall, prosthesisside peak propulsion averaged across conditions was

31% greater with the powered prosthesis and peak propulsion asymmetry improved by 48% with

the powered prosthesis.

SUMMARY

The Power Knee is the first motor-driven microprocessor knee in the world. Flexion and

extension are powered by active support to replicate concentric and eccentric muscle activity.

Advanced sensors precisely detect the user's movements and send them to the microprocessor,

which uses cutting-edge algorithms to enable the knee to respond to the user's needs. A

powerful motor allows for both consistent stance and free swing phases. Power Knee supports
symmetrical weight distribution and natural gait by providing active extension while standing up,

controlled resistance when descending, active flexion and extension while walking, and energy

returning stance flexion.

REFERENCE

• https://media.ossur.com/image/upload/pi-documents-global/Power_Knee.pdf

• https://www.ossur.com/en-us/prosthetics/knees/power-

knee#specificationContentAnchor

• https://www.virginiaprosthetics.com/technology_bionics.html

• https://jneuroengrehab.biomedcentral.com/track/pdf/10.1186/s12984-019-0583-z.pdf
Title: LUKE ARM

by: Mobius Bionics

Group 4: Bionic Solution

Cofreros, Regil

Diaz, Julienne

Sindol, Seychelle

Dionio, Lea Denise

Meriveles, Izra Joy

Gumayan, Patrick

Bayona, Ranel

Torrato, Arvin

Baltazar, Marese
ABSTRACT

The LUKE (Life Under Kinetic Evolution) arm is a modular prosthetic arm developed by DEKA

Research & Development Corp. (founded by Kamen) with funding from the Defense Advanced

Research Projects Agency (DARPA), and now manufactured by Mobius Bionics LLC. The LUKE arm

is configurable for levels of amputation ranging from shoulder to forearm. The hand has multiple,

preprogrammed grips using four powered degrees of freedom.

Mobius Bionics has announced the commercial introduction of the LUKE arm, the first prosthetic

arm cleared by the U.S. Food and Drug Administration in the new product category for integrated

prosthetic arms.

Features of the advanced prosthesis include:

• A powered shoulder with the capability to reach overhead or behind the back

• A powered elbow with the strength to lift a bag of groceries from floor to tabletop

• A powered, multi-movement wrist with the precision, range of motion, and dexterity to hold

a glass of water overhead or at waist level without spilling

• A hand with four independent motors and a conforming grip to hold everything from

delicate items such as a phone or an egg to heavy items such as a gallon of milk without

worrying that the item will slip or break

• An innovative grip-force sensor that senses how firmly something is being grasped and

communicates that information to the user

• A variety of ways to control the arm, including electromyographic (EMG) electrodes and

foot-mounted inertial measurement sensors


• Protection against water and dust – offering peace of mind when used inside and outside

the home.

OTHER FEATURES

• Proportional Speed Control - allows for more fluid motion by letting the user control how

fast the joints move by adjusting how gently or aggressively they trigger the input signal.

• Compound Wrist - combines the movements of Wrist Flexion and Extension with Ulnar and

Radial Deviation which allows users to grasp objects above the head or below the waist

while keeping the hand level.

• Optional Internal Battering - Humeral and Shoulder Configurations are orderable with an

optional internal battery that can be used by itself or in conjunction with the external

battery to extend usage time.

• Conforming Grasp - The LUKE hand has a powered thumb, powered index finger and

combined powered middle, ring and pinky fingers that allow the hand to conform to

different objects in multiple grip patterns.

• Tactile Feedback - A tactor (vibratory motor) can be mounted to the user’s socket to

provide vibratory feedback. This can be activated by sensors in the thumb and/or by

switching modes and grips.

• Virtual Reality Training - The software used by the prosthetist to set up the controls of each

arm has a simulated arm which allows users to test and practice their controls while making

any desired changes prior to donning the arm.


DATE OF INVENTION

The LUKE Arm was originally developed for DARPA by DEKA Research and Development

Corporation and approved for commercial use by the FDA in 2014. Mobius Bionics then took over

the commercialization of the arm in late 2016.

In June 2017, two Veterans with arm amputations became the first to receive new generation

LUKE arms. In February 2018, U.S. Air Force Veteran Ron Currier became the first person to be

fitted with two LUKE Arms.

ADVANTAGES

● Effective as an alternative functional arm for an upper limb amputee patient

● Customizable depending on the level of Upper limb amputation

● Water Resistant

● Offers flexion and extension in the hand, rotation of the shoulder and rotation of the

elbow.

● Has a unique alternative control method – the foot control.

● Provides increased functionality.

● It is the only powered shoulder joint available on the market.

● Available for three levels of amputation:

○ lower arm or trans-radial,

○ mid-arm or trans-humeral, and

○ shoulder disarticulation
DISADVANTAGES

● Cannot be used by patients with lower limb amputation since it serves as the control

Intuitive Wireless Foot Controls

● Not recommended for neurological disorders that are prone to fatigue

● Significantly more expensive than all prosthetic products available on the market.

● There is no knowledge about the long-term effects and the lengths of time it can be worn.

● Very expensive (Costs £200k per unit)

● Estimated short lifecycle and only a two-year warranty (it will need replacing every two

years)

● Does not conform to UK safety standards.

● Extremely heavy (at the shoulder level it is fitted to a socket weighs over 10kg

METHODS

IMU – Intuitive Wireless Foot Controls

In addition to the many control input options, the LUKE arm may be controlled with Inertial

Measurement Units (IMUs) that are typically worn on the user’s shoes. They read the tilt of the

user’s foot and interpret each movement like a joystick to control the arm.

• Control arm functions with foot movements

• Up to 2 IMUs can be used at a time along with other input options

• IMUs are sealed and waterproof

• Charged with a wireless charging pad


• Walk detect feature automatically disables IMU inputs when the user is walking and re-

enables them as soon as the user stops walking

Grip Patterns of Luke Arm

• Power Grip - used to grasp larger objects such as bottles, handles, etc.

• Tool Grip - can be used to grasp a tool handle and independently operate the index finger

to trigger the tool. It can also be used for many other applications such as typing.

• Fine Pinch Closed Grip - the tips of the thumb and index finger come together while the

middle, ring, and pinky fingers are closed. The fine pinch closed grip allows the user to

pick up and grasp small items or pinch a zipper, for example.

• Fine Pinch Open Grip - is similar to the fine pinch closed grip except the middle, ring, and

pinky fingers remain open and extended. The fine pinch open grip may be useful in

grasping items where the closed fingers would interfere.


• Lateral Pinch Grip - the thumb and index finger come together allowing the user to grip

items such as keys, pens or pencils, forks, knives, or spoons.

• Chuck Grip - thumb engages the index and middle fingers directly, creating a three finger

hold. It can be used to grasp round objects such as door knobs, bottles, cups, etc.

10 Powered Joints

The LUKE arm is the only commercially-available prosthesis with a powered shoulder, allowing a

shoulder-level amputee to reach over their head. In its shoulder configuration, the LUKE arm

features ten powered joints.

• Shoulder Abduction and Adduction

• Shoulder Flexion and Extension

• Humeral Rotation

• Elbow Flexion and Extension

• Wrist Pronation and Supination

• Ulnar and Radial Deviation

• Thumb Abduction and Adduction

• Index Finger Flexion and Extension

• Flexion and Extension of Other Fingers


RESULTS

At Discharge

1. Satisfaction with the LUKE Arm, as measured by the TAPES in patients accepting the

prosthesis, will be rated “satisfied” or “very satisfied” by 75% of patients

2. Satisfaction with services will be rated positively by 85% of patients

At 1 Month

1. 75% of patients will be using the prosthesis

2. Satisfaction with services will be rated positively by 85% of patients

At 1 Year

1. 75% of patients fit with the LUKE Arm will be using the prosthesis at 1 year

2. Satisfaction with the LUKE Arm, as measured by the TAPES will be rated “satisfied” or “very

satisfied” by 75% of patients

3. Satisfaction with services will be rated positively by 85% of patients

SUMMARY

It is still early days for the product. There remain very few users worldwide (less than ten) and

consequently there is very little data to test the long term capability of the product at this

stage. The early research indicates that there are still significant technical areas of development

for the prosthesis as well as practical problems that make other products on the market more

attractive to the amputee. In addition, there is the geographical hurdles, as the LUKE arm is not

currently produced or approved outside the US, and most still need to be fitted there. Whilst
the prosthetics industry shows no signs of slowing down, it is likely that upper limb prostheses

will show the greatest technological development in the short term future. The LUKE arm

remains a work in progress but is undoubtedly a product that could benefit certain upper limb

amputees if development continues. For the time being, however, the significant price

differential for much smaller functional gain means that the LUKE arm is unlikely to be suitable

in most cases, particularly where there is a compensation shortfall due to a liability split.

REFERENCES

Https://www.mobiusbionics.com/luke-arm/

https://www.therobotreport.com/luke-prosthetic-arm-sense-touch-move-response-thoughts/

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