Diana Suciu

Restoring Mobility Confidence in Amputees, a literature review of Integrated Lower Limp Sensory Prosthetics

Abstract:
Background: Individuals with lower limb loss experience a significant decline in their mobility and confidence in
navigating varied terrain after amputation. New advancements in commercially available products have made
prosthetics lighter, and more reliable; with the advent of microprocessor knees, and powered ankles to help
ambulation. However, these new devices have done little to improve amputee reliance on their prosthesis, as
knee, ankle, and hip surgeries of the intact limb are still common, due to amputees putting excessive pressure
and strain on their intact side. For lower-limb amputees the critically important aspect for displaying integrated
reliance on their prosthesis and ensuring confidence in maintaining balance, preventing falls, and responding
to unexpected agitations, is sensory input. Objective: In this work, we will report and review the peer-reviewed
literature available on the latest advancements in integrated lower limb sensory prosthesis. Results: The
papers included in this review describe the design of the novel systems, their users, length of usage time,
functionality, and progress in ambulatory tasks the users experienced with the integrated lower limb prosthetic
systems. Publications on integrated sensory prosthetic legs mainly focus on the development of new
technologies, and acute studies with participants operating in mainly lab settings. Significance: This review
provides information on the methods for sensory feedback systems in lower limb prosthetics. Integrated lower
limb prosthesis receive very little attention and have low appreciation in literature when compared to integrated
hand prosthesis, or brain computer interfaced robotic limbs. Integrated sensory prosthetic leg units are shown
to be useful to many unilateral amputees and should receive more attention and higher acceptance.

Introduction:
Lower limb loss results in a substantial disturbance of sensorimotor coordination. Despite centuries of
prosthetic innovation lower limb amputees constantly face challenges during ambulation. Lower limb amputees
experience a decreased sense of balance and ambulation confidence (SITE), an increased risk of falling
(SITE), and an increased cognitive burden when accomplishing simple ambulatory tasks when compared to
able bodied individuals (SITE). As a result of this loss of coordination confidence, and increased mental load,
many amputees adapt an asymmetrical gait (SITE). This unbalanced gait leads to chronic back pain, as well as
injury in their intact knees, hips which can require surgery (SITE). The causes for these ongoing issues and
challenges for lower limb amputees has been attributed to the stiff mechanical properties of their prosthetic
limbs. Commercially available prosthetics do not provide the users with the ability to adjust their locomotion
based on sensory information. The main method amputees receive any somatosensory feedback from their
prosthetic limb is via interactions between the prosthetic limb socket and their residual limb.
Recent studies have suggested that incorporating somatosensory feedback into the prosthesis of lower limb
amputees would allow an increased in confidence, and thus allow for a more natural gait, thus decreasing
injury risk. These new studies have begun to investigate the potential of integrating sensory feedback into
lower limb prosthetics in two main modalities: implanted sensory feedback systems, and external feedback
systems.
Implanted sensory feedback systems rely on the subject to undergo a surgery in which an electrode is placed
on the sciatic within the residual limb. Once the subject has recovered, they are trained to distinguish sensation
in their phantom limb when the nerve is excited through the electrodes. There are two implanted modalities
which will be discussed in this review C-FINES (cuff or flat interface nerve electrode) and TIMES (Transversal
intrafascicular multichannel electrodes).
External sensory feedback systems are less common than implanted systems, they rely on noninvasive
methods for eliciting environmental awareness to the prosthetic user. The non-invasive nature of these
systems makes them a desirable possibility for individuals who cannot or do not wish to undergo surgery for
increased prosthetic ambulation ability. However, due to the rare nature of these somatosensory feedback
systems only one external sensory method will be reviewed in this paper, the Vibrotactile Feedback System.
The Vibrotactile Feedback System is a relatively lightweight wearable system which delivers vibrations on the
prosthetic users’ residual limb to alert them of balance perturbations and balance changes.
In the present review, we focus on the latest emerging technologies in the field of integrated neuroprotheses.
We depict the different existing approaches for providing sensory feedback, the experimentation process in
which improvements in confidence and ambulatory ability are classified, and look at the future prospects of
integrated sensory lower limb neuroprosthesis.

Methods:
Implanted Electrodes for Integrated Neuroprothesis
Directly interfacing with the remaining nerves within the residual limbs of amputees can be an effective method
in eliciting useful sensations in people with different levels of amputation. There are multiple studies that
investigate the feasibility of restoring sensation in lower limb amputees via implanted electrodes. In this review
we will focus on the two most recent immerging implant technologies, the C-FINES and TIMES systems.

C-FINES
In the studies conducted by Christine and Charkar et al (CHECK SPELLING), two individuals with unilateral
transtibial amputations were implanted with high-density composite flat interface nerve electrodes (C-FINES).
During the outpatient implantation procedure each participant received three 16 contact C-FINES along their
sciatic nerves. The C-FINES are flexible and allow for gentle reshaping around the sciatic nerve with little to no
pressure to the nerve itself, resulting in high electrode contact and no agitation to the participants. This method
allows for a minimally invasive electrode however it may result in lower selectivity during neural excitation.
After implantation the C-FINE’s leads were routed through a percutaneous incision on the subject’s upper
thigh, out of the area of disturbance from the prosthetic socket. Once the incisions were healed the electrical
stimulation trials began. The participants underwent tests weekly for upwards of seven months, and
intermittent tests for up to three years after initial implantation. Elicited sensations are perceived immediately
and are interpreted by the participants as originating from the missing limb. Subject’s reported sensations
included tactile and proprioceptive sensations.

TIMES
(NAMES) et al papers conducted a study with three individuals with unilateral transfemoral amputations who
were implanted with the TIMES system for 90 days. Each subject received four individual TIMES electrodes in
the distal most section of their remaining tibial branch of the sciatic nerve of their residual limb. The TIMES
electrodes are pointed and slim allowing them to be easily inserted interfascicularly across the diameter of the
sciatic nerve. This allows stimulation to be highly selective, exciting individual fascicles responsible for foot and
ankle sensation. Additionally, it also makes stimulation highly sensitive, as the excitation signals do not need to
travel through the nerve myelination to activate an action potential. Similar to the C-FINE system the cables
were tunneled from the end of the residual limb to the upper tight where the cables were made percutaneous.
No information was provided regarding the recovery time of subjects after implantation. During the first month
after implantation the elicited sensations perceived by stimulating the electrodes was characterized. During this
90-day study subjects reported sensations of muscle movement and tactile feedback from their phantom limb.

External Stimulators as an Accessible Alternative:

Implanted systems may not be a viable option for all amputees interested in a sensory feedback system.
Though tending to be less sensitive, non-invasive options are cheaper and more accessible to all potential
users. There are multiple systems designed to integrate sight, sound, and touch feedback to the user through
their prosthetic, however none have come into widespread appreciation or application. This review looks at one
of the most recent external sensory feedback systems, the Vibrotactile Feedback System.

Vibration Feedback System

The Vibrotactile Feedback System, developed by (NAME) et al is a unique system that utilizes vibration as the
main feedback modality for its users. The feedback system consists of a pressure insole with four force
sensors, which went under to prosthetic foot. Four vibration motors were worn medio-laterally on the subject’s
thigh which cued to the four sensors of the insole. All of the electronics for the insole sensitivity and the
vibrating tractors were contained in a waist pack that could be easily worn by the user. In their mobility studies,
both able bodied and amputee participants were recruited. Able bodied participants wore ski boots to restrain
their ankles and reduce foot sensation as a proxy to a prosthetic leg. The studies relied on the subjects
learning how to interpret and discriminate the meaning of the vibration from the thigh-mounted tractors. The
feedback system was highly mobile and adjustable, allowing the user to modulate the tractor’s strength to their
desired levels of comfort.

Experimental Methods
For each of the three sensory feedback systems discussed above, two sets of tests were conducted: a
sensation focused and a mobility focused set of experiments. For the sensation tests the subjects were
instructed to do ‘Passive Tasks’ such as sitting or standing, then which the sensory feedback method was
activated and the subjects reported their elicited sensations as a result of the feedback. In the Mobility tests the
subjects were asked to do more complex tasks (such as walking an obstacle course) while their vision was
limited in some capacity. The subjects conducted the complex task with and without sensory feedback, and
they were compared against an able-bodied control and against themselves to measure their improvement
over each trial. There were factors that were individual to each feedback modality which will be elaborated
upon further in the following sections of this review.

Sensation Tests
C-FINES Sensory Methods
During the sensation focused experiments for the C-FINE feedback system, two transtibial amputees were
instructed to sit comfortably with their prosthesis removed and their intact foot on the floor while each channel
of the C-FINE implanted electrode was stimulated at 2 second increments. The subjects were asked to report
their subjective sensations and drew maps of each sensation on a diagram of their phantom limb. This
experiment spanned 7 months, with each participant coming into the lab weekly undergo this sensory
experiment. Changes in the subject’s phantom limb perception and sensation in the residual limb were
assessed at the beginning of each session via questionnaires.

CFINES Sensory Results

It was found that stimulation via C-FINES elicited sensations in discrete areas of the subject’s missing limb with
different modalities in both participants. During the first two weeks of the study the reported locations and
sensations were inconsistent for the same set of stimulation parameters. After three weeks of the study
perceived sensations became much more consistent with the location and modality of the reports becoming
more repeatable.
Based on the reported sensory location maps it was concluded that there was indeed selective activation of the
sciatic nerve through the different C-FINE contacts, as the reported sensations vary in location of the foot and
residual limb. This ability to distinguish distinct areas of the residual and missing limb appeared to aid in
subject’s prosthetic embodiment as well. Prior to the initial stimulation subjects were told to close their eyes
and point to where their big toe on their phantom limb was (6 and 11 cm bellow the end of the residual limb
respectively). After stimulation the subjects reported their phantom limb residing closer to the floor (14cm and
27cm respectively). This telescoping of the phantom limb persisted in each subject between sessions and even
increased as the experiments continued.

TIMES Sensory Methods

During the TIMES sensory experiments the three transfemoral subjects had their nerve stimulation
characterized during the first month post electrode implantation. During this initial characterization each
electrode channel was connected via an electrical stimulator which distributed electrical current pulses at
variable duration, intensity, and frequency. Utilizing a dedicated graphical user interface subjects described the
type, location, and intensity of the elicited sensation they felt during these initial stimulations.
After the initial characteristics of stimulation were discerned, the ability for the subjects to distinguish specific
elicited targeted sensations was assessed. Three passive tests were conducted to determine the ability for the
participants to distinguish touch, proprioception, and a combination of the two. Subjects prosthetics were
outfitted with a pressure insole on the foot and a gyroscope on the knee which connected to the TIMES
electrodes. The subject’s prosthetic was given to the experimenter’s, and while the participant was blindfolded,
and acoustically insulated, the experimenters manipulated the participant’s prosthetic. During the touch test the
participants were asked to identify the location of the pressure points on the pressure insole administered by
the experimenter. In the proprioception trials the subjects had to recognize the angle the knee was placed in.
The final combined trial asked the participants to do both at once. Overall, the participants performed more
than 1224 recognition trials.

TIMES Sensory Results

It was found that the TIMEs system elicited sensation in all participants during the initial characterization data
collection phase. Each subject had a distinctly unique sensation map that the experimenters used to create the
insole and knee feedback system. During the passive touch tests, it was found that all participants achieved a
performance of approximately 90% in distinguishing pressure applied to individual foot regions. During the
proprioceptive trials there was more variation across subjects, ranging from 70-80% accuracy during the
experiments. Finally, during the combined scores two of the subjects retained consistent scores within the 70%
range, while the third participant consistently had an accuracy of 90%. When asked to identify touch or flexion
events without stimulation accuracy rates of the subjects dropped down to a chance levels.

Vibration Sensory Methods

A total of 24 persons with unilateral transtibial amputation were recruited to participate in the vibrotactile
sensory study. During the sensory experimental trials, the subjects wore a custom-made device that
transmitted feedback from a pressure sensor insole under the prosthetic foot in real time to four vibrating
tractors located on the thigh of the residual limb. Once the vibrating tractors were fitted to the participant, they
underwent a tractor tuning process. During the tuning process it was ensured that there was minimal vibration
during a subjects neutral standing position, and that vibration increased when the pressure pads under the foot
were loaded. Each of the four vibrating tractors on the thigh correlated with the four pressure pads under the
foot (indicating forefoot, 2 midfoot, and heel).
Three balance sensory tests were conducted with and without the vibrotactile feedback system: standing
balance, limits of stability, and rhythmic weight shifting experiments were conducted. All sensory balance tests
were performed on a Balance master force plate system, which is capable of rotating around a single axis at
ankle level of the participant. During the standing balance tests subjects were asked to maintain a standing
posture for 20 seconds under four conditions: with stable support and eyes open, stable support with eyes
closed, swaying support with eyes open, and swaying support with eyes closed. The subject’s ability to
maintain balance was documented, any adjustments, foot adjustments, steps, or falls were recorded. In the
second set of experiment in which the participants’ limits of stability was investigated, participants had to
rapidly shift their center of gravity following visual cues provided by a computer. Subjects had to adjust their
center of gravity according to a target set on a screen as quickly as possible and maintain the stance for eight
seconds without stepping out of position or falling. In the final set of experiments that tested subjects rhythmic
weight shifting abilities in which subjects adjusted their center of gravity in rhythmic time with a cursor on the
computer screen, with the goal being to adjust their body weight to match the cursor movement as closely as
possible, again any missteps or falls were documented during this stage.

Vibration Sensory Results

During the standing balance trials, all subjects completed the four conditions, however six falls were reported
across three participants. No falls were reported during the limits of stability or rhythmic weight shifting tests.
There was no statistical difference was reported in the stability of participants with or without the vibrotactile
feedback in all three trials. Thus, the use of this vibratory feedback system on transtibial amputees poses no
benefit or hinderance when conducting passive balance-based tasks.

Mobility Tests
C-FINES Mobility Methods
Fourteen able-bodied participants served as a control group. On average, able-bodied control participants
were 34±16 years old. Six volunteers with unilateral below-knee (trans-tibial) amputations were enrolled in this
study, and three of them also performed the test using the sensory neuroprosthesis C-FINE system, whose
experiments and results will be the main focus in this review. All BKAs were male with an average age of
57±10 years.
Subjects were blindfolded and asked to cross a randomized ladder. The ladder had rungs that could be
randomly spaced 19, 28.5, 38, or 47.5 cm apart. There were 6 different orientations of the ladder that were
utilized to minimize participants learning the ladder. Participants were blindfolded before the arrangement of
the ladder rungs in each trial. Participants were instructed to walk in a ‘foot-over foot’ manner, step on top of
the rungs one at a time, and to not step on the floor or ladder side rails. The blindfolded, horizontal ladder
walking test was thought to approximate challenging real-world scenarios in a controlled setting, such as
mimicking walking outside in the dark, when carrying items that block the ground, or other high fall risk
activities for prosthetics users. Each trial consisted of crossing the ladder in both directions, with the option to
take a break after the first crossing. Force-sensing pressure insoles were placed in the participants shoe to
track where they stepped to later evaluate their navigation strategy. Pressure readings from insole were
collected at a sampling rate of 1000 Hz.
Participants performed two practice trials and 16 data collection trials. In order to evaluate the influence of the
sensory neuroproteins the three bellow knee amputees with the C-FINE implanted preformed additional 28
trials (12 without stimulation). Trials with C-FINE stimulation were impossible to blind to the participants, so
they were randomly inserted throughout the 28 additional trials.

C-Fines Mobility Results

The primary outcome measures for this experiment were foot placement accuracy and the time it took to
complete each trial. Video recordings of the trials were reviewed to determine foot placement accuracy.
Accuracy was defined by the errors an individual took in each trial, errors included: missing a rung, slipping off
a rung, stepping on the floor, stepping on two rungs at once, or stepping on the side rail. Participants were
allowed to search with their foot ahead of them, but could not place it or put weight on it.
For the subjects with the C-FINE sensory neuroprosthesis, improvement seemed to be highly dependent on
their navigation style. Subjects who were fast and thus likely to have many accuracy errors improved their
accuracy while retaining their speed. Subsequently, subjects who were slow, but highly accurate retained their
high accuracy but were able to navigate the course faster with sensory feedback. It is also important to not that
a decrease in overall error rate while using the sensory neuroprosthesis was predominantly caused by a
decrease in errors made with the prosthetic foot.

TIMEs Mobility Methods

Three transfemoral (???) amputees were recruited for this study. Once the implantation surgery was
conducted and the subjects had healed and their sensations had been characterized the pressure insole and
knee motion sensors were integrated with the subjects’ prothesis without prior training of the user. To
determine if the TIMES neuroprothesis system could assist walking capacity, three functional mobility
assessments were conducted: Stair accent / and decent, an obstacle course, and walking in a straight line with
and without sensory feedback conditions.
During the stairs test, the subjects were asked to ascend and descend an angular staircase, climbing up five
steps and going down on three steps. Subjects completion time of each set of complete ascends and
descends was monitored. This task was of particular interest to the research as navigating stairs is reported to
be one of the most challenging situations in lower limb amputee’s daily life. Ascending and descending stairs
are one of the most challenging situations in an amputee’s daily life.
In order to evaluate if sensory feedback impacted the subject’s ability to not slip and fall, they were instructed
to walk a platform while their inferior field of vision was obscured. The subjects walked at a self-selected space
and had to navigate unseen obstacles the researchers put in their way. The number of slips, stumbles, and
falls was recorded for each trial.
In order to test the potential agility gained due to restored sensation via the TIMES sensory feedback system,
subjects were asked to walk foot-over-foot in a straight line. If subjects misstopped (???) and did not precisely
walk on the line it was recorded as an error.
Finally, to investigate the subject’s integration with the prosthetic system, their cognitive burden was measured.
While wearing an EEG subjects were asked to walk while counting the number of ‘odd’ tones played to them
during a set of tones played over a set of headphones. The subjects repeated this trial with and without
sensory feedback, as well as a control trial while passively sitting in a chair.

TIMEs Mobility Results

As soon as subjects received their prosthetic leg with the integrated TIMES sensory system they reported
perceived sensations coming from their phantom foot and leg in accordance with walking. It was reported by
the participants as being an intuitive system, and that the sensations elicited were due to the interaction with
their prosthetic foot to their environment, and the movement of their prosthetic knee.
During the stair assessment, a higher number of laps were was able to be achieved by the three subjects with
the sensory feedback on, resulting in a higher reported mobility than without stimulation. For the obstacle
course trials, the number of falls decreased when sensory feedback was activated as well. Additionally,
subjects had a 35-50% increase in the accuracy to walk on a straight line with sensory feedback than without.
Overall subjects preformed much better during their functional tasks with feedback than without. It also
appears the sensory feedback decreases subject’s cognitive load, as during the EEG experiments it was
shown that only during control and sensory feedback conditions did subjects have the cognitive resources to
identify and count the target tones.

Vibration Mobility Methods

The wearable vibrotactile feedback system has been evaluated on 14 participants in total. 12 control
participants and 2 unilateral transtibial prosthesis were put through simulated stair tasks in which their ability to
discern foot position with and without feedback was measured. The 12 control subjects were asked to wear a
stiff ski boot in order to eliminate plantar foot sensation, thus simulating prosthetic wearing conditions. In the
experiment the participants were asked to utilize vibration from the upper thigh tractors of the feedback system
or to use the sensory feedback from their regular prosthetic/ski boot during a blind stair stepping task. In the
stepping task the participants stood in front of a hidden step with their lower field of vision obscured, the
experimenter would set the hidden stair to a randomize height in which the subject would have to navigate onto
without slipping, tripping, or miss stepping. 120 total trials were broken into 60 conditions with vibrotactile
feedback, and 60 without.

Vibration Mobility Results

Over the course of the experimental trials each participant wore the vibrotactile feedback device for an
average of two hours. Over that time there were no complaints of discomfort, prosthetics users responded very
favorably to the device. During the stair stepping challenge all but two participants showed improvement in
accuracy with the feedback system. The accuracy without the feedback system averaged 77.1%, while with the
vibrotactile feedback system accuracy averaged 82.5%. For the two prosthetic users, both showed improved
accuracy with feedback. One participant had an improvement of 20% accuracy, while the other had an
improvement of 15%. This study demonstrated that the implementation of a non-invasive, wearable sensory
feedback method has the ability to improve foot placement perception during a functional mobility task.

Discussion:

C-Fines:
Involves Major invasive surgery. Electrodes are percutaneous so has potential for infection is real, or
even breakageing of mechanical/electrical hardware. Potential for re-implantation if the CUFF electrodes reject
over time. However, it does seem to be a good option for a stable, long term system (over several years), if
they could make the system wireless.

TIME
A study of this technology has not occurred for longer than 3 months, which given the nature of
interfasicular electrodes and their overall instability makes me question how viable this system would be for
longer term. However it does seem to have a higher accuracy of location with less drift over the C-Fines, so if
the system can be applied long term, and the subject is eligible for an invasive surgery it could be a fantastic
option for restoring sensation in the future. It was an informative experiment to see that the integrated system
did relive cognitive load on subjects during functional tasks. I would like to see similar studies done on the
other two systems discussed in this review.

Vibration:
(was more of an initial conceptual study, so the numbers weren’t as robust as the other two) This
technology does not require a major surgery which is a plus, however it is currently quite a large and relatively
unwieldy system, as it develops it can get smaller. However, a study to compare how it fairs long term against
implanted technology is to be seen. The fact it is external means adjustments will be easier, and do you (???)
have the risk of bodily rejection as implantable devices have.

Papers Reviewed:

Charkhkar, Hamid, et al. “High-Density Peripheral Nerve Cuffs Restore Natural Sensation to Individuals with
Lower-Limb Amputations.” Journal of Neural Engineering, vol. 15, no. 5, 2018, p. 056002., doi:10.1088/1741-
2552/aac964.

Charkhkar, Hamid, et al. “Sensory Neuroprosthesis Improves Postural Stability during Sensory Organization
Test in Lower-Limb Amputees.” Scientific Reports, vol. 10, no. 1, 2020, doi:10.1038/s41598-020-63936-2.

Christie, Breanne P., et al. “Ambulatory Searching Task Reveals Importance of Somatosensation for Lower-
Limb Amputees.” Nature News, Nature Publishing Group, 23 June 2020, www.nature.com/articles/s41598-020-
67032-3.

Rokhmanova, Nataliya, and Eric Rombokas. “Vibrotactile Feedback Improves Foot Placement Perception on
Stairs for Lower-Limb Prosthesis Users.” 2019 IEEE 16th International Conference on Rehabilitation Robotics
(ICORR), 2019, doi:10.1109/icorr.2019.8779518.

Rusaw, David et al. “Can vibratory feedback be used to improve postural stability in persons with transtibial
limb loss?.” Journal of rehabilitation research and development vol. 49,8 (2012): 1239-54.
doi:10.1682/jrrd.2011.05.0088

Petrini, Francesco et al. “Enhancing functional abilities and cognitive integration of the lower limb prosthesis”
Journal of Science Translational Medicine.vo. 11, 2019

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Dietrich, Caroline, et al. “Sensory Feedback Prosthesis Reduces Phantom Limb Pain: Proof of a Principle.”
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