| CTRI Number |
CTRI/2025/10/095835 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Virtual Reality Relaxation for Post-Stroke Recovery: A Randomised Controlled Trial
|
|
Scientific Title of Study
|
Efficacy of Virtual Reality-Based Relaxation on Post-Stroke Anxiety, Fatigue, and Quality of Life: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjana Manoj Mohata |
| Designation |
Post graduate student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
OPD no. 19 G-1 floor KLES Dr. Prabhakar Kore Hospital Nehru Nagar, Belagavi, Karnataka, 590010 Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7028859912 |
| Fax |
|
| Email |
sanjanamohata2908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjana Manoj Mohata |
| Designation |
Post graduate student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
OPD no. 19 G-1 floor KLES Dr. Prabhakar Kore Hospital Nehru Nagar, Belagavi, Karnataka, 590010 Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7028859912 |
| Fax |
|
| Email |
sanjanamohata2908@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendrasingh Dharwadkar |
| Designation |
MPT (PhD) |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
OPD no. 19 G-1 floor KLES Dr. Prabhakar Kore Hospital Nehru Nagar, Belagavi, Karnataka, 590010 Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy, Belgaum, 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sanjana Mohata |
| Address |
KLEs Dr. Prabhakar Kore Hospital and MRC, Advance Physiotherapy Centre Neurology Physiotherapy Department room no 19, Nehru nagar, Belagavi, 590010 |
| Type of Sponsor |
Other [Sanjana Mohata] |
|
|
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 Sanjana Mohata |
KLEs Dr. Prabhakar Kore Hospital |
Advamce Physiotherapy Centre, OPD no 39, Room no 19, Neurology Department, KLEs Dr. Prabhakar Kore Hospital and Medical Research centre, Nehru Nagar, Belagavi, Karnataka, 590010 Belgaum, Karnataka
Belgaum
KARNATAKA |
7028859912
sanjanamohata2908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stroke |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Participants will be given the Virtual reality along with conventional physiotherapy. |
Virtual reality, along with conventional physiotherapy for 60 minutes, 5 days/week, for 2 weeks, we will provide a comfortable seating arrangement or reclining chair, then brief to participants on how to use the VR equipment will be given, then select a suitable VR relaxation environment (e.g., nature, scenery, a virtual world filled with sounds of nature). Guide participants to wear the VR headset and adjust for comfort, and check audio settings to ensure clarity and appropriate volume. Ensure the VR headset is properly set up and calibrated for comfort. Start the relaxation experience session of 20 minutes.
|
| Comparator Agent |
Progressive muscle relaxation along with conventional physiotherapy |
Progressive muscle relaxation, along with conventional physiotherapy, Instructions on how to relax using Jacobsons relaxation technique (progressive muscle relaxation and deep breathing) will be given. Ensure the person is in a quiet environment, free from distractions, then have them sit or lie down in a comfortable position. Instruct them to take a few deep breaths, inhaling through the nose and exhaling slowly through the mouth. Starting with the hand, followed by the upper limbs, shoulders, head, neck, chest, abdomen, and finally the lower limbs. muscle tension, for 10–15 s, and the relaxation process can be 15–20 s; each group
of muscles is repeatedly trained 3 times in sequence. Each session will last approximately 20 minutes.
At the same time, the patient takes a deep breath, inhaling through their nose and exhaling through their mouth.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Stroke patients who are willing to participate, with all genders of age group 18-65 years, Anxiety score of more than 22 on BAI, Score more than 36 on fatigue severity scale, Able to understand instructions and ability to sit through VR sessions
|
|
| ExclusionCriteria |
| Details |
Subjects who are medically unstable, History of epilepsy or seizure, Vestibular disorders, Impaired vision or hearing
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Beck Anxiety Inventory (BAI), Fatigue Severity Scale (FSS), Stroke Specific Quality of Life Scale (SS-QOL)
|
assessed on the first day of treatment and on the last day of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stroke Specific Quality of Life Scale (SS-QOL)
|
assessed on the last day of treatment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
14/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Anxiety in stroke patients is mainly due to their
concern about the prognosis status, e.g., recurrence, re-working abilities, the
occurrence of fall accidents, and so on. This suggests it is important to
continue to assess for anxiety 12 months or more after stroke onset. Being exposed to nature, including blue and green
natural environments, is good for both physical and mental health. evidence
shows that even if unable to engage directly in a natural environment, visible
exposure to nature scenes can be beneficial. Its effect on post-stroke anxiety, fatigue, and QOL
remains limited; hence, this study aims to investigate the effectiveness of VR as
a relaxation tool in stroke patients experiencing anxiety and fatigue and poor
quality of life. By conducting a randomised controlled trial, we seek to
determine whether VR can provide a viable, accessible, and engaging method to
enhance mental well-being and improve rehabilitation outcomes. |