| CTRI Number |
CTRI/2024/12/077668 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECTIVENESS OF VIRTUAL REALITY TRAINING ON HAND MOVEMENTS AMONG STROKE PATIENTS WITH PARALYSIS |
|
Scientific Title of Study
|
EFFECTIVENESS OF IMMERSIVE VIRTUAL REALITY TRAINING ON HAND MOTOR FUNCTION AMONG HEMIPARETICS |
| 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 PRIYA M |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SATHYABAMA INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY, DENTAL BLOCK, SATHYABAMA INSTITUTE OF SCIENCE AND TECHNOLOGY, JEPPIAR NAGAR, SH 49 A, CHENNAI, TAMIL NADU 600119
Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu 600119
Chennai
TAMIL NADU
600119
India |
| Phone |
08148967036 |
| Fax |
|
| Email |
priyavishnu835@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VISHNU PRIYA M |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SATHYABAMA INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Department of Physiotherapy, Sathyabama Institute of Science and Technology, Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu 600119
Chennai
TAMIL NADU
600119
India |
| Phone |
08148967036 |
| Fax |
|
| Email |
priyavishnu835@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VISHNU PRIYA M |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SATHYABAMA INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu 600119
Chennai
TAMIL NADU
600119
India |
| Phone |
08148967036 |
| Fax |
|
| Email |
priyavishnu835@gmail.com |
|
|
Source of Monetary or Material Support
|
| SATHYABAMA INSTITUTE OF SCIENCE AND TECHNOLOGY- INSTITUTIONAL SEED FUND, JEPPIAR NAGAR, CHENNAI - 600119, TAMIL NADU, INDIA. |
|
|
Primary Sponsor
|
| Name |
SATHYABAMA INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu, INDIA 600119 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 PRIYA KUMARI HOD |
SATHYABAMA HOSPITAL |
Physiotherapy Out patient department, First floor, Sathyabama Institute of Science and Technology, Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu 600119
Chennai
TAMIL NADU |
9789807079
priyakumari.physiotherapy@sathyabama.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VELS INSTITUTE OF SCIENCE AND TECHNOLOGY - INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CONVENTIONAL PHYSIOTHERAPY INTERVENTION FOR HAND FUNCTION |
REGULAR PHYSIOTHERAPY REHABILITATION GIVEN BY DIFFERENT FUNCTIONAL ACTIVITIES |
| Intervention |
IMMERSIVE VIRTUAL REALITY TRAINING FOR HAND MOTOR FUNCTION |
USING THE DESIGNED GAMING APPLICATION "SYNAPSE VR" - PATIENTS ARE IMMERSED INTO VIRTUAL REALITY ENVIRONMENT BY WEARING VR GOGGLES. SET OF 12 GAME ACTIVITIES ARE GIVEN TO IMPROVE HAND MOVEMENTS |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Acute to subacute stroke more than one month of onset to six months
Hemiparetic subjects - Ischemic 0r hemorrhage stroke
Conscious and comprehensive MMSE – 24- 30
Educational level – Basic qualification
|
|
| ExclusionCriteria |
| Details |
Multiple infarcts or hemorrhage
Cognitive impairment
Vertigo
Motion sickness
Other neurological, visual, musculoskeletal conditions
Sensory problems
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Post test – fugyl meyer assessment UE Hand component
2.Box and block test
|
1st measure - BASELINE
2nd measure - AFTER 6 WEEKS
3rd measure - after follow up of 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BDNF - BRAIN DERIVED NEUROTROPHIC FACTOR |
8.0–927.0pg per ml |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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) |
17/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
Virtual reality training is one of the advanced form of rehabilitation. Immersion into unrealistic environment provides various sensory feedback. The synapse VR application designed to improve hand motor function among hemiparetic patients. The activities are believed to facilitate the hand motor function. Hemiparetic subjects will be recruited based upon inclusion and exclusion criteria and randomly allocated into two groups. Informed consent will be obtained. participants are assigned and evaluated for the outcome measures. Group A receives Immersive virtual reality intervention and group B receives conventional rehabilitation exercise program for 6 weeks and follow up measures were taken after 12 weeks. |