| CTRI Number |
CTRI/2025/12/098596 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to Compare the Effect of Virtual Reality and Muscle Feedback Therapy on Improving Arm function and Independence in People with Long-Term Stroke Paralysis. |
|
Scientific Title of Study
|
Effect of Virtual Reality versus Electromyographic Biofeedback on Motor Function and functional Independence of the upper limb in subject with chronic Hemiplegic stroke–A comparative interventional study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROSE SUNGURA |
| Designation |
PG Scholar |
| Affiliation |
Marwadi University |
| Address |
Marwadi University Morbi Road Gavridad 360003 Rajkot Gujarat
faculty of Health science
Physiotherapy department
room number MB557
INDIA.
Rajkot
GUJARAT
360003
India |
| Phone |
7069842034 |
| Fax |
|
| Email |
rose.sungura132629@marwadiuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashish Kakkad PT |
| Designation |
THESIS GUIDE |
| Affiliation |
Marwadi University |
| Address |
Marwadi University Morbi Road Gavridad 360003 Rajkot Gujarat
faculty of Health science
Physiotherapy department
room number MB567
INDIA.
Rajkot
GUJARAT
360003
India |
| Phone |
9824415797 |
| Fax |
|
| Email |
ashish.kakkad@marwadieducation.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ROSE SUNGURA |
| Designation |
PG Scholar |
| Affiliation |
Marwadi University |
| Address |
Marwadi University Morbi Road Gavridad 360003 Rajkot Gujarat
faculty of Health science
Physiotherapy department
room number MB557
INDIA.
Rajkot
GUJARAT
360003
India |
| Phone |
7069842034 |
| Fax |
|
| Email |
rose.sungura132629@marwadiuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ROSE SUNGURA |
| Address |
Marwadi University Morbi Road Gavridad 360003 Rajkot Gujarat
faculty of Health science
Physiotherapy department
room number MB557
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 |
| Dr Rose Sungura |
Marwadi Physiotherapy Center |
Marwadi university
Morbi Road Gavridad 360003 Rajkot Gujarat INDIA
Rajkot
GUJARAT |
7069842034
rose.sungura132629@marwadiuniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Marwadi University ethical 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 |
ELECTROMYOGRAPHY BIOFEEDBACK |
Pheezee, a wearable device will be used to measure the focused motor function parameters.
The top and bottom Pheezee modules will be placed in such a way that it will attached above and below the surface of the joint being evaluated.
The EMG cable will be connected by using adhesive electrodes that will be placed on the selected muscles.
After placing on the device, the patient data will be filled in the device for data collection and preparing of the report and then patient will be asked to perform each selective activity such as;
Pinching, lifting blocks, grasping was given to the subjects to target wrist flexor, extensor, and finger flexors muscle activation.
Also hitting and catching of objects was given to target subject deltoid, triceps and biceps muscle activation.
Drawing and painting activities was given for the activation of shoulder flexors, elbow extensors and flexors as well as wrist extensors
Objects placing, reaching and real ball throwing activity will be given to increase subject real-time response.
|
| Comparator Agent |
NIL |
NIL |
| Intervention |
VIRTUAL REALITY |
Subjects will take the training program at the Marwadi University campus OPD and other Physiotherapy centers in and around Rajkot city.
The meta quest 2® formerly known as oculus meta quest 2®, with 128 GB storage and built-in hand-tracking capabilities game will be installed with a game for the hand, elbow and shoulder joint activities.
Hand physics lab, which helps in hand tracking without controllers, the tasks involved in this game are lifting blocks, pinching and grasping and grabbing objects.
Koord couch, which helps to regain reflex and coordination of the single hand through catching and hitting the targets.
Open brush/Multi brush, for controlling hand and arm motion through 3D drawing and painting and,
Custom unity VR-based tasks, for checking real time response through virtual ball throwing, reaching and object placing.
The training materials will be sourced from official meta quest store on the meta quest 2 system and all training session will be done in a 3D environment where Subjects will perform various activities.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with chronic hemiplegic stroke/6 months post stroke.
Subjects who voluntarily agree to participate and provide informed
consent.
Mini-Mental State Examination score of 24 or higher.
Subjects without visual impairment and visual field defects.
Subjects who understand and carry out instructions. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Functional independence measure (FIM)
2. Fugl Meyer assessment (FMA) |
At the baseline and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
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)
|
28/12/2025 |
| 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
|
Subjects with chronic hemiplegic stroke faces significant challenges in motor functional independence, of the upper limb which affect to carry out the activities of daily living such as grooming, slicing, picking and dropping, reaching out to object, etc. Standard methods often lack engagement and fail to provide real-time feedback for motor learning. EMG biofeedback enhances neuromuscular control, while VR offers motivation through interactive environments. The comparative impact of VR vs EMG biofeedback on improving upper limb motor function outcomes in subject with chronic hemiplegic stroke remained unexplored. This study aims to bridge this gap by providing an innovative, engaging rehabilitation approach tailored to their needs. |