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CTRI Number  CTRI/2020/07/026461 [Registered on: 09/07/2020] Trial Registered Prospectively
Last Modified On: 28/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [Virtual Reality Training]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of video game based treatment on eye and hand movements among stroke patients 
Scientific Title of Study   Effect of Head- Mounted Virtual Reality gaming on oculomotor and upper limb function among individuals with chronic stroke 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Maurya 
Designation  Post Graduate student of Master of Optometry 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8637818028  
Fax    
Email  snehamaurya317@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Krithica S 
Designation  Assistant Professor- selection grade 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861330980  
Fax    
Email  krithica.s@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Sneha Maurya 
Designation  Post Graduate student of Master of Optometry 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8637818028  
Fax    
Email  snehamaurya317@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Research institution and hospital 
 
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 
Sneha Maurya  Pre clinic  Department of Optometry, Room no.303, 3rd Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
8637818028

snehamaurya317@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital lnstitutional Etlrics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I638||Other cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physical Therapy  It is the treatment of movement disorders caused by impairments of joints and the muscles that move the joints. Here physical therapy will be given for improvement of Upper limb function. 
Intervention  Head Mounted Virtual Reality display  A head mounted display is a display device, worn on the head or as part of a helmet, that has a small display optic in front of one or each eye. This Video games training consists of games that involves the movement of body parts such as hand, head, and eye. Each game will run for 15 minutes with 5 minutes breaks. - Based on Visual acuity of the patients, size of the target can be changed. - Depending upon the Visual field defects, the target can be shifted to the viewing side. - Speed of the game can be adjusted depending upon the patient’s performance. - In case of diplopia, occlusion of one eye can be done. - The therapy will be given with best corrected visual acuity. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Chronic Stroke of ≥6 months
2. Arm paresis (Chedoke-McMaster Arm Scale of 2-6 /7) with voluntary elbow flexion/extension of at least 20° per direction
3. Visual Acuity: Ability to see the largest targets in the game binocularly 
 
ExclusionCriteria 
Details  1. Presence of Ptosis
2. Bilateral paresis
3. Contracture at wrist or Elbow greater than 50% of the functional Range.
4. Shoulder Pain > 7/10 on numerical VAS Scale
5. Complex Regional Pain Syndrome
6. Any other associated Neurological Deficit that has alternate prognosis from Stroke or Orthopaedic Deficit that prevents mobility of upper limb to perform the functional exercise.
7. Any Cardiovascular disease that can preclude intervention.
8. Major Depression as identified Beck Depression inventory
9. Patients with history of motion sickness
10. Cognitive deficit and Aphasia deficit 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Horizontal and Vertical time taken in seconds, H/V Ratio using Developmental eye movement test.
2. Reading Speed using MN Read chart (time in second)
 
Twice during study period 
 
Secondary Outcome  
Outcome  TimePoints 
1. Fugyl Meyer Upper Limb Score
2. Reach Performance Scale Score
3. Score of Action Research Arm test 
Twice during study period 
 
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   Phase 2 
Date of First Enrollment (India)   01/08/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Stroke is most common form of acquired disability and it affects the activities of daily living. It can lead to loss of body balance, body control, weakening of the muscles, eye movement, reading disability. Hence, there is need to analyze the effect of Head- Mounted Virtual Reality gaming on oculomotor and upper limb function among chronic stroke subjects.


This is a study with the duration of 1 year, and total sample size is 30 and will be divided into two groups; Control and Intervention groups. Participants will be selected on the basis on inclusion and exclusion criteria. Written consent form will be given to each participant before starting the therapy. Each participant will undergo some tests such as assessment of vision, body movements, eye movements, rate of reading speed, etc., by the trained Physiotherapist and Optometrist before going for the therapy. It is a home- based therapy, Control group will receive conventional physical therapy and Intervention group will receive use of Video games training which consists of three games that involves the movement of body parts such as hand, head, and eye and conventional physical therapy also. Each game will run for 15 minutes with 5 minutes breaks. For the first time demonstration will be given to participants then will approach to therapy.

Objective: To assess the effect of Virtual Reality gaming on:

-Rate of reading

-Oculomotor function

-Impairment of upper limb

-Quality and compensatory movements of the upper limb during reach-to-grasp task

-Upper limb function

As there is no published evidence that shows how visual function improves by giving Virtual Reality training, so there is a need to understand how Virtual Reality training will help in improvement of oculomotor functions.
Even though there are studies that reports different forms of Virtual Reality as a valuable method in Rehabilitation of stroke especially in upper limb motor function but there is lack of studies analyzing the improvement in upper limb function using head mounted
Virtual Reality.


 

 
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