| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|