| CTRI Number |
CTRI/2026/01/101989 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| 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
|
Comparing virtual reality and watching movement videos for stroke recovery in people with depression |
|
Scientific Title of Study
|
Effect of virtual reality versus action observation therapy in post stroke survivors with depression- A randomized control 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 |
Dr Sanjiv kumar |
| Designation |
Professor |
| Affiliation |
KLE institute of physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7624919304 |
| Fax |
|
| Email |
tejaswinipatrot@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjiv kumar |
| Designation |
Professor |
| Affiliation |
KLE institute of physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7624919304 |
| Fax |
|
| Email |
tejaswinipatrot@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendrasingh dharwadkar |
| Designation |
associate professor |
| Affiliation |
KLE institute of physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghvendrasingh@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar kore Hospital and Medical Research center |
|
|
Primary Sponsor
|
| Name |
KAHER UNIVERSITY |
| Address |
KLEs Dr. Prabhakar Core Hospital and Medical Research Center |
| 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 |
| Sanjiv kumar |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi. |
KLEs Dr. Prabhakar
Kore Hospital and
Medical Research
Center, Room No. 39,
Sagar Floor, Advanced
Physiotherapy Centre,
Department of
Neurophysiotherapy,
Belgaum, Karnataka.
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
7624919304
tejaswinipatrot@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and 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 |
Action Observation therapy group |
The session will be conducted by therapists trained in administering the protocol, the session will be of 40 mins, 3 times a week for 4 weeks, participants will have to come to the physiotherapy OPD for the same, where a video of different movements was shown to the patients via videography and then they were asked to perform the same movement along with conventional therapy for the same |
| Comparator Agent |
Mental imagery |
MI protocol included the imagination of scenarios that are calming for the patients, which will be administered for 30 minutes and then followed by the conventional therapy protocol. Then they would be administered the same protocol for 4 weeks, 3 sessions per week |
| Intervention |
Virtual reality |
Virtual reality protocol will be given via Head mounted device, where a video will play for 30 mins, which will include sceneries and a peaceful music for relaxation for 3 times a week for 4 weeks, which will be give along with conventional therapy. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Day(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
subjects with occurrence of first stroke, minimum time post onset of stroke should be 3 months
2. Diagnosed cases of Depression and evaluated by a Psychiatrist. Participants with a score of 11 to 16 on Becks Depression Inventory II will be recruited.
3. Vividness of mental image scale will be used at screening tool to assess patients ability to perform the mental imagery efficiently.
4. Montreal Cognitive assessment (MoCA) will be used to assess the cognitive ability and a minimum score of 26 or more will be recruited. |
|
| ExclusionCriteria |
| Details |
1. Subjects with previous history or cases with presence of any diagnosed Psychiatric illness.
2. Subjects not willing to participate in the study and difficulty in comprehension.
3. Participants with history of associated Neurological or Orthopedics conditions.
4. Subjects with visual impairments or vestibular dysfunctions and recent eye surgeries will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BDI-2 |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Montreal Cognitive Assessment |
10 minutes |
| Stroke-specific quality of life |
10 minutes |
| Motor assessment scale |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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="2"
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
|
Title: Effect of virtual reality versus action observation therapy in post-stroke survivors with depression - A randomised control trial This study investigates the effect of virtual reality versus action observation therapy in post-stroke survivors with depression. Depression is a common psychological disorder that often accompanies post-stroke. Virtual reality and action observation therapy have shown successful improvement. Its immersive, multi-sensory approach can be beneficial in treating post-stroke depression. This is an experimental interventional study involving 74 stroke survivors with at least one episode of stroke and a minimum time from the onset of stroke should be 3 months between the age group of 25-75 years conducted over 4 weeks. Participants will undergo a structured training protocol of duration of 3 sessions per week for 4 weeks, for 85 minutes. The study aimed to evaluate the effectiveness of virtual reality and action observation therapy in reducing depression among stroke survivors.
|