| CTRI Number |
CTRI/2024/12/077790 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of mirror therapy with or without EMG- biofeedback in improving hand function of stroke patients |
|
Scientific Title of Study
|
COMPARATIVE EFFICACY OF MIRROR THERAPY WITH OR WITHOUT
ELECTROMYOGRAPHY BIOFEEDBACK IN IMPROVING SUPINATION AND
HAND FUNCTION OF STROKE PATIENTS A RANDOMISED CLINICAL TRIAL
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
APARNA GOSWAMI |
| Designation |
MPT STUDENT |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
2C Nunda mullick road Kolkata
2C Nunda mullick road Kolkata
Kolkata
WEST BENGAL
732101
India |
| Phone |
7602981631 |
| Fax |
|
| Email |
aparnagoswami1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANWESH PRDHAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
2c nunda mullick road kolkata
2c nunda mullick road kolkata
WEST BENGAL
732101
India |
| Phone |
07602981631 |
| Fax |
|
| Email |
anweshpradhan696@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
APARNA GOSWAMI |
| Designation |
MPT STUDENT |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
2C nunda mullick road kolkata
2C nunda mullick road kolkata
WEST BENGAL
732101
India |
| Phone |
07602981631 |
| Fax |
|
| Email |
aparnagoswami1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| NOPANY INSTITUTE OF HEALTHCARE STUDIES
2c nunda mullick road kolkata PIN 700006 |
|
|
Primary Sponsor
|
| Name |
NOPANY INSTITUTE OF HEALTHCARE STUDIES |
| Address |
2C Nunda mullick road. Kolkata-7000006 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| APARNA GOSWAMI |
Nopany physiotherapy clinic (room no 1) |
2c nunda mullick road kolkata
Kolkata
WEST BENGAL |
07602981631
aparnagoswami1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NOPANY INSTITUTE OF HEALTHCARE STUDIES ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MIRROR THERAPY
EMG BIOFEEDBACK |
30 Patients with stroke will be chosen based on
inclusion and exclusion criteria. Random sampling will be done and patients will
be allocated into two groups to find out the effects of Mirror Therapy with or without
EMG-Biofeedback in improving supination and hand function in upper limb of stroke
patients. Group A will be treated with Mirror Therapy for 20 minutes a day, 5 days
per week for 3 weeks and EMG-Biofeedback for additional 30 minutes, 10 minutes
each muscle of Supinator and Extensor Carpi Radialis and Extensor carpi ulnaris
muscle for 5 days per week for 3 weeks. Group B will be treated only with mirror
therapy for 20 minutes 5 days a week for 3 weeks. Exercises are Exercises involves.
1st Week of Intervention:
I. Supination and Pronation of the forearm,
II. Wrist flexion and extension
2nd Week of Intervention:
I. Finger flexion and extension, abduction, adduction and opposition
II. Picking up block
3rd Week of Intervention:
I. Collecting blocks of separate diameter into bucket.
II. Grasping and releasing
III. Counting and taping
IV. Clinching and opening of the hand
. Pre-intervention data will be
collected before the commencement of the study. After 3 weeks of study, post intervention data will be collected. Pre- and post- intervention data will be analyzed
by using proper statistical tools |
| Comparator Agent |
MIRROR THERAPY |
During the Mirror Therapy the patient will be seated on chair close to a
mirror box.
Patient will place the affected hand behind the mirror that it will not be
visible to him.
ï‚· The unaffected hand is placed in the sight of the mirror.
ï‚· This practice incorporated various movements of the unaffected side while the
patient has to look into the mirror and watch the image of his/her unaffected
hand.
ï‚· In this process the patient may perceive the illusion of the unaffected hand in
the mirror.
ï‚· The patient will be asked to the movements with both hands simultaneously.
23
Exercises involves.
ï‚· 1
st Week of Intervention:
I. Supination and Pronation of the forearm,
II. Wrist flexion and extension
ï‚· 2nd Week of Intervention:
I. Finger flexion and extension, abduction, adduction and opposition
II. Picking up block
ï‚· 3rd Week of Intervention:
I. Collecting blocks of separate diameter into bucket.
II. Grasping and releasing
III. Counting and taping
IV. Clinching and opening of the hand
|
|
|
Inclusion Criteria
|
| Age From |
39.00 Year(s) |
| Age To |
77.00 Year(s) |
| Gender |
Both |
| Details |
Brunnstrom stage of upper extremity of 3 or more
Score ≥24 in Mini-Mental State Examination scale
First episode of unilateral stroke
Both gender |
|
| ExclusionCriteria |
| Details |
Acute or chronic injury to the upper limb
Subluxation of shoulder
Contracture, tightness, deformities of upper limb
Shoulder hand syndrome
Loss of vision |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugl-Meyer upper extremity assessment scale
Goniometric measurement |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Forearm supination range
Wrist extension range |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THESIS TOPIC: Comparative Efficacy of Mirror Therapy with or without Electromyography-Biofeedback in Improving Supination and Hand Function of Stroke Patients – A Randomised Clinical Trial. 2. SUMMARY: One of the post-stroke impacts found among the patients is the motor impairment of hand. Loss of supination and proper hand function following the stroke is frequent. This is one of the most challenging conditions that a patient may face. It may lead to poor quality of life. Mirror Therapy helps to enhance the functioning of upper limb in hemiplegic patients. EMG- Biofeedback also helps to recover upper extremity function following stroke. Hence this study will try to find out the comparative efficacy of Mirror Therapy with or without ElectromyographyBiofeedback in improving the supination and hand function in patients with stroke. 3. PURPOSE OF THE STUDY: The purpose of the study is to find out the effect of Mirror Therapy with or without EMG-Biofeedback in improving the supination and hand function in stroke patients. 4. OBJECTIVE: To determine and compare the efficacy of Mirror Therapy with or without EMG-Biofeedback in improving supination and hand function of stroke patients and to compare the effects between them. 5. MATERIAL AND METHODS: 30 Patients with stroke will be chosen based on inclusion and exclusion criteria. Convenient sampling will be done and patients will be allocated into two groups to find out the effects of Mirror Therapy with or without EMG-Biofeedback in improving supination and hand function in upper limb of stroke patients. Group A will be treated with Mirror Therapy for 20 minutes a day, 5 days per week for 3 weeks and EMG-Biofeedback for additional 30 minutes, 10 minutes each muscle of Supinator and Extensor Carpi Radialis and Extensor carpi ulnaris muscle for 5 days per week for 3 weeks. Group B will be treated only with mirror therapy for 20 minutes 5 days a week for 3 weeks. Pre-intervention data will be collected before the commencement of the study. After 3 weeks of study, postintervention data will be collected. Pre- and post- intervention data will be analyzed by using proper statistical tools |