Updated 23/11/12

FACULTY OF PHYSICAL THERAPY

APPLICATION FOR ETHICAL REVIEW

NOTES:

 Answers to questions must be entered in the space provided.

 An electronic version of the completed form should be submitted to the Research Ethics

Officer, at the following email address: …ethical@pt.cu.edu.eg . Please do not submit

paper copies.

 If you have any queries about the form, please address them to the Research Ethics Team.

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FACULTY OF PHYSICAL THERAPY OFFICE USE ONLY:

Application No:
APPLICATION FOR ETHICAL REVIEW Date Received:

1. TITLE OF PROPOSAL
EFFECT OF POLARIZED LIGHT ON IMMUNE
SYSTEM
IN MAJOR BURN
2. THIS PROPOSAL IS:
Physical TherapyStaff Research Proposal
Physical TherapyPostgraduate Research (PGR) Student Proposal
Master Doctoral Other

Other (Please specify):

3.INVESTIGATORS

PLEASE GIVE DETAILS OFStudent(FOR PGR STUDENT PROPOSAL)or first author for staff Research
Proposal

Name: Title / first name / family name MOHAMED TAHSEEN OTHMAN

Highest qualification & position held: Master of physical therapy
Department/Faculty/ University Burn and Surgery department
Telephone: 01227184961
Email address: M_t_othman@hotmail.com

PLEASE GIVE DETAILS OF ANYCO-SUPERVISORS ORCO-INVESTIGATORS (FOR PGR STUDENT

PROPOSAL) or co- first author for staff Research Proposal

Name: Title / first name / family name PROF.DR.AMAL MOHAMED ABD EL BAKY
Highest qualification & position held: professor for surgery department
Department/Faculty/ University Faculty of physical therapy-cairo university
Telephone:
Email address:

Name: Title / first name / family name Prof. Dr.AHMED MOHAMED KENAWY
Highest qualification & position held: Professor for Plastic Surgery
Department/Faculty/ University Consultant of Plastic Surgery – Faculty of medicine
Cairo University
Telephone:
Email address:

Name: Title / first name / family name DR.EMAN MOHAMED OTHMAN

Highest qualification & position held: ASSIT.PROF of Physical Therapy
Department/Faculty/ University Surger Department - Cairo University
Telephone:
Email address:

3. SUMMARY OF PROPOSAL

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PURPOSE:The main objectives of the study are:

1. To assess the therapeutic efficacy of polarized light as physical therapy

modality on improving the immune system in major burns patients.

2. To evaluate the therapeutic efficacy of bioptron Hyperlight Therapy on the

activity of both T-lymphocytes and monocytes in the blood..
BACKGROUND:

The need of this study developed from the lack in the quantitative
knowledge and information in the published studies about the ideal polarized
light application in enhancing immunomodulatory system in major burn.

Unfortunately there is a contradiction opinion about the best type

recommended in the role of polariezed hyperlight therapy approaches in the
treatment and immune system complication in major burns.

This study investigates the immunomodulatory effects of polychromatic

polarized light therapy (PLT) on human immune cells. While there is some
evidence demonstrating a clinical effect in the treatment of certain
conditions, there is little research into its mechanism of action (Bjordal et
al., 2006).
HYPOTHESES:

It will be hypothesized that:

 There will be benefit of polarized light and bioptron hyperlight therapy

on immunomoduatory system of wounds in major burned patients

RESEARCH QUESTION:" Does polarized hyperlight therapy is effective on immune

sysem in major burn patients?"

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4. CONDUCT OF PROJECT

Please give a description of the research methodology that will be used

Procedures of the study:

- A verbal explanation about the importance of this study procedures, main aims
and conceptual approach were explained to every patient.

- The procedures of this study will be divided into two main categories:

Measurement procedures ():

(1) Preparatory phase:

In this phase, each patient was achieved the following steps:

- All participants will be signed an institutional review board approved informed

consent statement prior to testing.

- Subjects will be familiarized with equipment and test procedures before testing
commenced.

- All patients will be given an explanatory session before the evaluation procedure
based on the protocols set.

Primary brief medical history had been obtained, and demographic data had been
recorded, including age, sex, height, weight, general health status, and activity
level to decide if the patient was able to undergo the experiment.

- Each subject's history will be taken carefully to collect information about his
general condition, physical activity and current medication.

- Measurements will be performed under standardized conditions as the following:

Measurements will be carried out by the same investigator.

-The measurements procedures will be conducted two times, before treatment

application (pre-treatment) and after eight weeks of treatment application
(post-treatment).
.

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Patients will be introduced to the lab at the scheduled dates, had taken the
general knowledge about the system, and revised the evaluation procedures
prior to onset of evaluation.
- Each subject will be tested in a single session.
(2) Measuring phase
-Blood sample will be taken from patient before and after end of therapeutic
procedures.
-Colony count :T-lymphocytes and monocytes
Therapeutic procedures:
This current study will be designed to prove the therapeutic effect
Bioptron polarized hyperlight therapy on the immune system in major burns,
so the treatment protocol will be applied through the following steps and
phases:
Therapeutic intervention for the study was started at the same time for
all groups of the study as following;
Exercise therapy protocol:
(1) Preparatory phase:
 Preparation of the patients:
 The patients will be checked carefully to make sure there will be no
contraindications.
 Every patient will be given information about the measurement and
treatment procedures before the beginning of the treatment.
 All participants were asked to be cooperating with treatment programme.
(2) Application phase:

The Bioptron Light Therapy treatment protocol:

The procedure of this protocol will be achieved under the following steps:
sessions were applied three times weekly for a total period of treatment
for eight weeks with a special protocol of major burn patients of 10 minutes
for every session (Courneya et al., 2009).

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1-Wound preparation: the wound will be cleaned at first by hydrogen

peroxide, saline rinse and betadine.
2-BLT device preparation: the plug of the BLT unit will be inserted into the
main current supply; the on/off switch will be switched on. Then set the
treatment parameters of BLT.
3-BLT application: point the light beam at the area to be treated, holding the
device at right angle (90°) perpendicular to the surface of the burn wound and
maintaining a distance of 10 cm from the surface of the burn wound and
applying the BLT for about 10 minutes.
4-Frequancy of application: applied once daily (session every 24 hours) for
two months
5-Unplug the device after use and it is advisable to prolong the BLT for one or
two weeks if wound closure occurred before the end of the treatment period
(two months) in order to strengthen the treated area.(Sattayut et al., 2003).

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5. PARTICIPANTS AS THE SUBJECTS OF THE RESEARCH

Describe the number of participants and important characteristics (such as age, gender, intellectual
ability etc.). Specify any inclusion/exclusion criteria to be used.

The subjects will be chosen under the following criteria:

Inclusive criteria:
Criteria of selecting the patients from hospitals include the
following:
 All patients will be of both sexes.
 The age of the patients will be ranged from 35 to 45 years.
 All patients will bew examined by a physician before the study.
 Major burn patients will be performed.
 All patients had the same medical care and free from any pathological
conditions that might affect the results.
 All patients will be suffered from second degree of burns .
 All patients will be received a good explanation of treatment and
measurement devices.
 All patients should be conscious and ambulant.
Exclusive criteria:
The subjects were excluded from the study if they meet one of the
following criteria;
 Patients suffering from skin abnormalities (skin malignancy in the
area will be treated).
 Patients who suffering from anemia.
 Patients who suffering from associated or inhalation injuries..
 Patient with life threatening disorders as renal failure, myocardial
infarction.
 Patients those are pregnant.
 Patients who suffering from myasthenia gravis, hyperthyroidism,
hemorrhage, acute viral disease, acute tuberculosis, mental disorders
or those with pacemakers will be excluded from the stud (Irion, 2002
and Thomas, 2000).

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6. RECRUITMENT
Please state clearly how the participants will be identified, approached and recruited.
Note: Attach a copy of any poster(s), advertisement(s) or letter(s) to be used for recruitment.

Sixty patients (male or female) will be suffered from electrical or chemichal

second degree burn (partial thickness) and will be selected randomly from
ELECTRICITY Hospital in Cairo, and these patients were randomly
subdivided into two equal groups; (30 patients for each):

7. CONSENT
Describe the process that the investigator(s) will be using to obtain valid consent. If consent is not to
be obtained explain why. If the participants are minors or for other reasons are not competent to
consent, describe the proposed alternate source of consent, including any permission / information
letter to be provided to the person(s) providing the consent.
I am freely and voluntarily consent to participate in a research program under the
direction of M.Sc.MOHAMED TAHSEEN OTHMAN
A thorough description of the procedure has been explained and I understand that I may withdraw
my consent and discontinue participation in this research at any time without prejudice to me.
Date Participant
‫إقرار‬
‫ محمد تحسين عثمان محمد‬/‫أقر انا الموقع أدناه أنني وفقت علي األشتراك في برنامج البحث تحت إشراف الباحث‬
‫وقد تم شرح خطوات البحث لي بالتفصيل وأنه من حقي أن انسحب من الدراسة في أي وقت أشاءالتاريخ‬
‫المشارك‬
Note: Attach a copy of theConsent Form, Participant Information Sheet (if applicable).

PARTICIPANT WITHDRAWAL
a) Describe how the participants will be informed of their right to withdraw from the project.
Before the beginning of the study the participants will be informed of their right orally that they can
with draw from the project at any time for any reason.

b) Explain any consequences for the participant of withdrawing from the study and indicate what will
be done with the participant’s data if they withdraw.

When the patient wants to withdraw , he should inform the researcher at first. Then his data will be
deleted .

8. CONFIDENTIALITY

a) Will all participants be anonymous? Yes No 

b) Will all data be treated as confidential? Yes No

Note: Participants’ identity/data will be confidential if an assigned ID code or number is used, but it will
not be anonymous. Anonymous data cannot be traced back to an individual participant.

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9. SIGNIFICANCE/BENEFITS
Outline the potential significance and/or benefits of the research

The need for this study designed from the lack of the primary related
studies and researches about the role of physical therapy for improve immune
system in patients with major burns .
Unfortunately there is a contradiction opinion about the best type
recommended in the role of physical therapy approaches in the treatment
complication post major burns.
The current study is an attempt to determine the preferable type affect
the immune system in major burns patients. Therefore, it is believed that the
value of the present study doesn't not lie in describing a new phenomenon but
in providing a quantative information to assess main points which play an
important role in planning the therapeutic program for such patients
(Greenhalgh et al., 2007).
10. RISKS

Outline any potential risks to INDIVIDUALS, including research staff, research participants, other individuals
not involved in the research and the measures that will be taken to minimise any risks and the
procedures to be adopted in the event of mishap

No risk is predicted in our study

11. DECLARATION BY APPLICANTS

I submit this application on the basis that the information it contains is confidential and will be used by the
Faculty of Physical Therapy for the purposes of ethical review and monitoring of the research project
describedherein, and to satisfy reporting requirements to regulatory bodies. The information will not be used
for any other purpose without my prior consent.

I declare that:
 The information in this form together with any accompanying information is complete and correct to
the best of my knowledge and belief and I take full responsibility for it.
 I will report any changes affecting the ethical aspects of the project to the Faculty of Physical
Therapy Research Ethics Officer.
 I will report any adverse or unforeseen events which occur to the relevant Ethics Committee via the
Faculty of Physical TherapyResearch Ethics Officer.

Mohamed Tahseen Othman

Name of Principal investigator/project supervisor: Prod.Dr.Amal Mohamed Abd El Baky

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