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CTRI Number  CTRI/2024/11/077344 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Virtual Reality-based ReMind device on upper limb dysfunction in stroke 
Scientific Title of Study   Efficacy of Virtual Reality-based ReMind device on upper limb dysfunction in stroke: A randomized controlled 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  Vishnu V Y 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  RN 704, Seventh floor CN CENTRE AIIMS New Delhi Ansari Nagar New Delhi 110029 South DELHI 110029 India

New Delhi
DELHI
110029
India 
Phone  9855480361  
Fax    
Email  vishnuvy16@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Vishnu V Y 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  RN 704, Seventh floor CN CENTRE AIIMS New Delhi Ansari Nagar New Delhi 110029 South DELHI 110029 India

New Delhi
DELHI
110029
India 
Phone  9855480361  
Fax    
Email  vishnuvy16@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vishnu V Y 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  RN 704, Seventh floor CN CENTRE AIIMS New Delhi Ansari Nagar New Delhi 110029 South DELHI 110029 India

New Delhi
DELHI
110029
India 
Phone  9855480361  
Fax    
Email  vishnuvy16@yahoo.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan P.O. Box No. 4911. Ansari Nagar New Delhi- 110029, India Ph: 91-11-26588895 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan P.O Box No. 4911 Ansari Nagar, New Delhi- 110029, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishnu V Y   All India Institute of Medical Sciences, New Delhi  Room No. 704, CN Centre Department of Neurology All India Institute of Medical Sciences, New Delhi Ansari Nagar New Delhi 110029
South
DELHI 		 9855480361

vishnuvy16@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I69||Sequelae of cerebrovascular disease,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  The control will now receive 1 hour home-based conventional physiotherapy. 
Intervention  Virtual Reality + Conventional Physiotherapy  The experimental group will now receive 1 hour of home-based therapy comprising of 30 minutes of VR therapy and 30 minutes of conventional physiotherapy, 5 times a week for 4 weeks. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age 18 to 75 years
Stroke onset greater than or equal to 3 months to less than 3 years
a diagnosis of stroke (haemorrhage or ischemia) confirmed through CT or MRI
MoCA greater than or equal to 18, ability to understand simple instructions
MAS score for spasticity ranging from 0 to 3, with the capability to perform VR exercises
able to sit independently for at least 60 minutes
Willingness to participate and sign an informed consent

 
 
ExclusionCriteria 
Details  i) Uncorrected auditory or visual disorder which is limiting the use of Virtual Reality headset.
ii) Musculoskeletal injury/ fracture in affected UE in the past 6 months that limit or restrict range of motion
iii) surgical wound or implants or surgical procedure like craniotomy.
iv) any uncontrolled or unstable medical condition, or other neurological disorder such as seizures.
v) any other impairment limiting the use of VR system
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in FMA Score at 1 month from baseline
 		 Change in FMA Score at 1 month from baseline
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Change in FMA Score at 3 months from baseline
 		 Change in FMA Score at 3 months from baseline
 
Action research arm test (ARAT) at 1 & 3 months from baseline  Action research arm test (ARAT) at 1 & 3 months from baseline 
Modified Ashworth scale (MAS) at 1 & 3 months from baseline  Modified Ashworth scale (MAS) at 1 & 3 months from baseline 
Modified Functional Reach Test (mFRT) at 1 & 3 months from baseline
 		 Modified Functional Reach Test (mFRT) at 1 & 3 months from baseline
 
Addenbrookes Cognitive Examination at 1 & 3 months from baseline  Addenbrookes Cognitive Examination at 1 & 3 months from baseline 
Stroke Impact Scale at 1 & 3 months from baseline  Stroke Impact Scale at 1 & 3 months from baseline 
MRC scale for strength at 1 & 3 months from baseline
 		 MRC scale for strength at 1 & 3 months from baseline
 
Function is Sitting test (FIST) at 1 & 3 months from baseline   Function is Sitting test (FIST) at 1 & 3 months from baseline  
Frenchay Aphasia Screen Test (FAST) at 1 & 3 months from baseline  Frenchay Aphasia Screen Test (FAST) at 1 & 3 months from baseline 
SF-36 at 1 & 3 months from baseline  SF-36 at 1 & 3 months from baseline 
MRS at 1 & 3 months from baseline  MRS at 1 & 3 months from baseline 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   16/12/2024 
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="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   This randomized controlled trial evaluates the efficacy of the ReMind device, a virtual reality (VR)-based rehabilitation tool, in stroke survivors. The primary objective is to assess its impact on upper limb motor function, while secondary objectives include examining its effects on spasticity, dynamic balance, cognition, and quality of life. Subacute and chronic stroke patients will be enrolled, with participants randomized into two groups. The experimental group will receive 45 minutes of VR-based therapy combined with conventional physiotherapy, administered five times a week for four weeks. The control group will receive standard physiotherapy care over the same period.  
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