| CTRI Number |
CTRI/2025/09/094945 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Virtual reality training to improve upper limb movement in stroke patients. |
|
Scientific Title of Study
|
Virtual reality training for upper limb rehabilitation in subacute stroke patients: A Quasi experimental study on improving motor function.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAGADISH KUMAR M |
| 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, Sidhapudur, Coimbatore-641044,
Tamil Nadu.
Coimbatore TAMIL NADU 641044 India |
| Phone |
9585886041 |
| Fax |
|
| Email |
jagadishkumarm0@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PORKODI R |
| Designation |
MPT(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, Sidhapudur, Coimbatore-641044,
Tamil Nadu.
Coimbatore TAMIL NADU 641044 India |
| Phone |
09443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PORKODI R |
| Designation |
MPT (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, Sidhapudur, Coimbatore-641044,
Tamil Nadu.
Coimbatore TAMIL NADU 641044 India |
| Phone |
09443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neuro rehabilitation center, Sri Ramakrishna Multi Speciality Hospital, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore-641044,
Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
JAGADISH KUMAR M |
| Address |
3RD FLOOR, 2ND ROOM, COLLEGE OF PHYSIOTHERAPY, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, 395 SAROJINI NAIDU ROAD, SIDHAPUDUR, COIMBATORE- 641044
Coimbatore
TAMIL NADU
641044
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 |
| PORKODI R |
Sri Ramakrishna Multi Speciality Hospital |
3rd floor, 2nd room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395, Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044. Coimbatore TAMIL NADU |
09443820164
porkodi.mpt@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: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Virtual Reality with Conventional therapy. |
15 repetitions for each exercises for 30 minutes per day, 5 days per week per session for about 6 weeks.
Shoulder Flexo-extension,
Shoulder Abducto-adduction,
Shoulder Rotations,
Elbow flexo-extension,
Wrist Flexo- extension and range of motion exercises.
|
| Comparator Agent |
Group B: Conventional therapy alone. |
15 repetitions for each exercises for 30 minutes per day, 5 days per week per session for about 6 weeks. Shoulder, elbow and wrist range of motion exercises. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Participant is aged 40 – 55 yrs.
Both males and females,
Both ischemic and haemorrhagic types of stroke,
Left MCA stroke is included,
A first episode of unilateral stroke with hemiparesis,
Stroke duration less than 6 months and more than 1 month,
Function in sitting test (score greater than 40),
Medically stable enough to participate in active rehabilitation,
Upper extremity motor deficits (Brunnstrom stage for upper extremity 4). |
|
| ExclusionCriteria |
| Details |
Uncontrolled blood pressure or angina,
Cognitive impairment (defined as score LESS THAN 24 MMSE),
Problems with auditory or visual functioning,
Fracture and joint dislocation,
Severe hemineglect,
Pusher’s syndrome,
History or current diagnoses of any other neurological OR psychiatric conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl-Meyer Assessment - Upper Extremity |
Pre test of individual participant will be assessed at baseline and post test will be assessed after 4-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
19/09/2025 |
| 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
|
The Global Burden of Disease Study suggested Stroke is the second leading cause of death globally and the third leading cause of premature death and disability as measured in Disability Adjusted Life Years (DALY). Upper limb motor impairment is a common disability in stroke. Afflicted patients need to undergo therapeutic exercises to restore motor function and independence. Virtual Reality (VR) is a technology that creates a simulated environment, allowing users to feel like they are in a different place or world. Virtual reality (VR) technology has emerged as a new technique in neurorehabilitation. It enables users to control and interact with the game console without the need to touch a game controller, through a natural gesture-based user interface. The device comes with an RGB camera and a depth sensor, which in combination provides full- body three dimensional motion capture capabilities and gesture recognition. . The aim is to investigate the effectiveness of virtual reality training on improving upper limb motor function as measured by the Fugl Meyer Assessment for Upper Extremity. The objective is to evaluate the effectiveness of virtual reality training on upper limb motor function in subacute stroke patients. Methodology: A quasi experimental study was conducted involving both males and females in subacute stroke patients aged 40–55 years with mild to moderate upper limb motor impairment will be divided into two groups: Group A will receive VR-based training along with conventional therapy, while Group B will receive conventional therapy alone (Range of motion exercises). The intervention will last up to 6 weeks with 5 sessions per week. Motor function will be assessed using the Fug Meyer Assessment for Upper Extremity before and after the intervention. Results: Pre-test and post-test intervention assessment may indicate significant improvements in both groups but greater improvement in group A. Expected Outcomes: It is expected that the combination of VR and conventional therapy will result in greater improvements in upper limb motor function compared to conventional therapy alone. Conclusion: If effective, VR-based training could be integrated into routine stroke rehabilitation to enhance motor recovery, patient motivation and cost-effectiveness. |