| CTRI Number |
CTRI/2025/04/085008 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Virtual reality rehabilitation and conventional physical therapy in improving balance and motor function in stroke patients |
|
Scientific Title of Study
|
Effect of virtual reality rehabilitation vs conventional physical therapy in improving balance and motor function in stroke patients pilot 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 |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Department of Physiotherapy Alvas College of Physiotherapy and Research Centre
AHC complex, AHC road, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Department of Physiotherapy Alvas College of Physiotherapy and Research Centre
AHC complex, AHC road, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Department of Physiotherapy Alvas College of Physiotherapy and Research Centre
AHC Complex, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of Physiotherapy and Research Centre, Alvas Health Centre complex, Moodbidri, DK, Karnataka Pincode 574227, India |
|
|
Primary Sponsor
|
| Name |
Alvas College of Physiotherapy and Research Centre |
| Address |
Moodbidri, Dakshina Kannada, Karnataka, Pincode 574227, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sridharan |
Alvas College of Physiotherapy and Research Centre |
Department of Physiotherapy, Alvas Health Center Complex, Moodbidri, Dakshina Kannada, Karnataka - 574227
Dakshina Kannada
KARNATAKA |
8147760381
sridharanphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Alvas College of Physiotherapy and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physical Therapy |
Upper limb exercise, lower limb exercise, balance exercise and gait training
The conventional rehabilitation is provided 5 times a week for 3 months
The total duration of the intervention is 3 months |
| Intervention |
Virtual reality rehabilitation |
Exercises, for balance, gait, upper extremity using Virtual rehabilitation incorporates immersive method of interface with the stroke survivors wearing a head mounted device and perform exercises, tasks related to their motor deficits. It includes upper extremity and lower extremity tasks related to gait and motor deficits The intervention is provided 5 days per week for 3 months
The total duration of the intervention is 3 months |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Individuals with ability read and write |
|
| ExclusionCriteria |
| Details |
Stroke patients with any co-morbid systemic conditions, musculoskeletal injuries or deformities in the past, willing to participate, cognitive dysfunctions, visual or hearing impairments |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale and
The scale of motor assessment |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2025 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
02/05/2025 |
| Date of Study Completion (Global) |
30/07/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study results could provide insights on the effect of virtual reality rehabilitation in improving balance and motor outcomes in stroke survivors |