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CTRI Number  CTRI/2025/07/091177 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to improve wrist range of movement in stroke survivors using virtual reality to watch and practice wrist bending and straightening  
Scientific Title of Study   TO STUDY THE EFFECTIVENESS OF VIRTUAL REALITY BASED ACTION OBSERVATION THERAPY FOR WRIST FUNCTION IN SUB-ACUTE AND CHRONIC STROKE PATIENTS :AN 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  METALIA HARDI RAJESHBHAI  
Designation  MPT IN NEUROLOGICAL CONDITIONS  
Affiliation  GOVERNMENT PHYSIOTHERAPY COLLEGE JAMNAGAR  
Address  Government physiotherapy college,Rameshwar nagar,jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9429272510  
Fax    
Email  hardimetalia111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Karishma Jagad  
Designation  Senior lecturer, MPT in Neurological condition, department of physiotherapy  
Affiliation  GOVERNMENT PHYSIOTHERAPY COLLEGE JAMNAGAR  
Address  Department of physiotherapy, goverment physiotherapy college, Rameshwar nagar, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9374141991  
Fax    
Email  karishma.jagad@gptcjam.edu.in  
 
Details of Contact Person
Public Query  
Name  METALIA HARDI RAJESHBHAI  
Designation  MPT IN NEUROLOGICAL CONDITIONS  
Affiliation  GOVERNMENT PHYSIOTHERAPY COLLEGE JAMNAGAR  
Address  Government physiotherapy college, Rameshwar nagar, jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9429272510  
Fax    
Email  hardimetalia111@gmail.com  
 
Source of Monetary or Material Support  
Neurological rehabilitation OPD of government physiotherapy college, Rameshwar nagar,Jamnagar, Gujarat -361008 
 
Primary Sponsor  
Name  Government physiotherapy college Jamnagar  
Address  Government physiotherapy college,Rameshwar nagar, jamnagar, gujrat-361008 
Type of Sponsor  Government medical college 
 
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 Hardi Metalia   Government physiotherapy college ,Jamnagar   Neurological rehabilitation out patient department
Jamnagar
GUJARAT 		 9429272510

hardimetalia111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee shree M.P. Shah Govt. medical college and G.G.Govt. Hospital, Jamnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional therapy   Other physiotherapy treatment according to need of patient  
Intervention  Virtual reality based action observation therapy   Action observation therapy (having visual of wrist flexion and extension)10 minutes,5 days a week for 4 weeks , active assisted wrist movement plus conventional therapy  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Have passed more than 7 days since onset. Can understand and follow instructions. Have more than 21 score in mini mental state exam . Have age between 20-70 years with difficulty in active wrist flexion and extension. Can sit independently for 10-15 minutes. 
 
ExclusionCriteria 
Details  Patient who has any kind of mental disease or disorder, musculoskeletal injury, impaired comprehension, visual defect. Previous experience of participation in VR based action observation therapy. spasticity grade 4 in Modified Ashworth scale.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fugl Meyer assessment for upper extremity wrist component  at baseline (first day) and at end of 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
range of motion of wrist flexion and extension  at baseline (first day) and at end of 4 weeks 
 
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)   01/08/2025 
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="10"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 15-08-2025 and end date provided 15-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Data will be collected from Neurological rehabilitation centre out patient department of government physiotherapy college Jamnagar . After collecting the data extraction of patients who are eligible for research will be done according to inclusion and exclusion criteria and information about research will be given to patient.  Consent of patient will be taken . Further all the patients will be divided into two groups. One group (experimental ) will recieve conventional therapy plus watch virtual reality based action observation therapy for 10 min  and active assisted movement of wrist , the other group will recieve conventional therapy only. Fugl meyer assesment score for upper extremity wirst component and active range of motion of wrist flexion and extension will be taken at baseline (first day) and at end of 4 weeks . The comparison of result will be done and conclusion will be made.  
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