| CTRI Number |
CTRI/2025/10/095870 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study in stroke patients to compare virtual reality based rehabilitation with routine physical therapy for improving hand and arm movements. |
|
Scientific Title of Study
|
Comparison of stroke population getting virtual reality rehabilitation versus stroke population getting physical rehabilitation. |
| Trial Acronym |
STROKE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Selva Balaji R |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu
Chennai
TAMIL NADU
602105
India |
| Phone |
9597369767 |
| Fax |
|
| Email |
bselva558@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Kannan |
| Designation |
Professor, General Medicine |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu
Chennai
TAMIL NADU
602105
India |
| Phone |
9710071284 |
| Fax |
|
| Email |
endork@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Selva Balaji R |
| Designation |
Post Graduate, General Medicine |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu
Chennai
TAMIL NADU
602105
India |
| Phone |
9597369767 |
| Fax |
|
| Email |
bselva558@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu, India. Pincode- 602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu, India. Pincode- 602105 |
| Type of Sponsor |
Private medical college |
|
|
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 Selva Balaji R |
Saveetha Medical College and Hospital |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, Tamilnadu, India. Pincode- 602105
Chennai
TAMIL NADU |
9597369767
bselva558@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coventional physical rehabilitation for upper extremity post stroke |
Standard physiotherapy exercises for upper extremity rehabilitation, Therapist supervised, 30 minutes/day session for 5-7 days |
| Intervention |
Virtual Reality based rehabilitation for upper extremity post stroke |
Non invasive device assisted therapy. 30 minutes/day session for 5-7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
(1) Participants must be aged 18 years or above.
(2) Diagnosis of acute stroke confirmed by neurological assessment including neuroimaging (MRI or computed tomography) within the last 12 months
(3) Absence of cognitive impairments / seizures.
(4) Able to follow verbal instructions related to the use of VR devices
(5) Patients with either of upper limbs affected. |
|
| ExclusionCriteria |
| Details |
(1)Patients who are below 18 years of age.
(2) Patients who aren’t willing to give consent for the study.
(3) Patients with both upper limbs affected.
(4) Patient who have no attention or Power 0 has been excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in upper limb motor function assessed using Fugl Meyer Assessment- Upper Extremity (FMA-UE) |
At baseline and after 1 week of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in upper limb motor function of stroke patients with rehabilitation using Fugl Meyer Assessment- upper extremity |
At the end of intervention (day 5-7) |
|
|
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)
|
20/10/2025 |
| 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="0"
Months="6"
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
|
COMPARISON OF STROKE POPULATION GETTING VIRTUAL REALITY REHABILITATION VS PHYSICAL REHABILITATION. VIRTUAL REALITY REHABILITATION IS A NOVEL , IMMERSIVE APPROACH FOR TREATMENT ALTERNATIVE TO PHYSIOTHERAPY USING PRINCIPLES OF MOTOR LEARNING IN REGAINING MOTOR FUNCTION IN PATIENTS WHEREIN VR GAMING SYSTEM PLAYS A VITAL ROLE IN TASK ORIENTED ACTIVE EXERCISES PROVING DEVELOPMENT OF NEUROPLASTICITY IN STROKE PATIENTS. HEREBY, WE COMPARE CLINICAL OUTCOMES WITH OTHER GROUP GETTING ONLY PHYSIOTHERAPY USING FUGL MEYER ASSESSMENT- UPPER EXTREMITY (FMA-UE) DURING THE PERIOD OF HOSPITAL ADMISSION. |