| CTRI Number |
CTRI/2025/08/093694 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Improving hand recovery in stroke survivors through biofeedback |
|
Scientific Title of Study
|
The effectiveness of EMG biofeedback and mirror visual feedback on improving hand function in subacute stroke. A Quasi experimental study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poornima D |
| Designation |
PG resident |
| Affiliation |
College of physiotherapy, Sri Ramakrishna institute of paramedical sciences |
| Address |
3rd Floor, 2nd room, College of physiotherapy, Sri Ramakrishna institute of paramedical sciences , 395, Sarojini naidu road, Sidhapudhur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9597218246 |
| Fax |
|
| Email |
poornimad103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Porkodi R |
| Designation |
Professor, Department of Neurology |
| Affiliation |
College of physiotherapy, Sri Ramakrishna institute of paramedical sciences |
| Address |
3rd Floor, 2nd room, College of physiotherapy, Sri Ramakrishna institute of paramedical sciences, 395, Sarojini naidu road, Sidhapudhur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Porkodi R |
| Designation |
Professor, Department of Neurology |
| Affiliation |
College of physiotherapy, Sri Ramakrishna institute of paramedical sciences |
| Address |
3rd Floor, 2nd room, College of physiotherapy, Sri Ramakrishna institute of paramedical sciences, 395, Sarojini naidu road, Sidhapudhur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3rd Floor, 2nd room, College of physiotherapy, Sri Ramakrishna institute of paramedical sciences , 395, Sarojini naidu road, Sidhapudhur, Coimbatore 641 044,India |
|
|
Primary Sponsor
|
| Name |
Poornima D |
| Address |
3rd Floor, 2nd room, COLLEGE OF PHYSIOTHERAPY, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, 395, Sarojini naidu road, Sidhapudhur, Coimbatore 641 044, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Poornima D |
Sri Ramakrishna multispecialty hospital |
Neurorehabilitation center, Sri Ramakrishna multispecialty hospital , Sarojini naidu road, Sidhapudhur, Coimbatore.
Coimbatore
TAMIL NADU |
09597218246
poornimad103@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G460||Middle cerebral artery syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
exercises with EMG biofeedback |
Wrist and finger ROM exercises with EMG biofeedback and Task based hand exercises for 45min per session,5 sessions per week, for 2 months. |
| Comparator Agent |
exercises with mirror visual feedback |
Wrist and finger ROM exercises with mirror visual feedback and Task based hand exercises, 45 min per session, 5 sessions per week, for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed left MCA ischemic stroke, Sub acute phase, Good static trunk balance, No history of use of EMG or mirror therapy, Brunnstrom stage 4,5
Minimum 10 degree of active flexion and extension of wrist |
|
| ExclusionCriteria |
| Details |
Associated neurological disorder, Cognitive disorder MMSC less than 24, Perceptual disorders, RSD, Subluxed shoulder, Pusher syndrome, Modified Ashworth scale more than 3 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
w/h Fugl meyer upper extremity
for hand function evaluation.
|
pre test of individual participant will be assessed before the first session and post test will be assessed by end of last session which is after 2 months follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Goniometer- wrist extension ROM |
pre test of individual participant will be assessed before the first session & post test will be assessed by end of last session which is after 2 months follow up. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
08/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Hand function impairment is one of the most disabling consequences of stroke, affecting up to 80% of stroke survivors. The loss of hand function and motor control severely limits the ability to perform essential activities of daily living such as, eating, dressing and writing there by reducing independence and quality of life. EMG biofeedback and mirror therapy have individually shown promising effects on hand recovery while advanced neurorehabilitation techniques such as robotic therapy, VR have been widely studied, direct comparison between EMG biofeedback and mirror therapy remains limited. This study aims to compare the effectiveness of EMG biofeedback and mirror therapy for improving hand function in sub-acute stroke. Based on purposive sampling method sub-acute stroke patients are taken from Sri Ramakrishna hospital from the department of neurorehabilitation center. Total number of 20 patients selected by inclusion and exclusion criteria. The patients are divided into two groups according to their availability and purposively allocated. The pre test measure was taken by FMA-UE scale and Goniometer for hand function and wrist extension ROM .A well explained consent form is given and the approval of patients are received. One group patients (10) are wrist exercise with mirror visual feedback, the other group (10) receives wrist extension exercise with EMG biofeedback. After 2 months of follow up the post test measure will be taken to determine the effects. |