| CTRI Number |
CTRI/2025/06/088693 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying the Immediate Effect of Watching 360° Virtual Reality Videos along with Physiotherapy on Walking Ability in People After a Stroke |
|
Scientific Title of Study
|
Immediate Effect of 360° Virtual Reality
Video-viewing on Parameters of Gait in
Individuals with Stroke |
| 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 Archana Gore |
| Designation |
Additional Professor |
| Affiliation |
Physiotherapy School and Centre, Seth G.S Medical College and KEM Hospital, Mumbai |
| Address |
Physiotherapy School and Centre, Seth G.S Medical College and
KEM Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Gore |
| Designation |
Additional Professor |
| Affiliation |
Physiotherapy School and Centre, Seth G.S Medical College and KEM Hospital, Mumbai |
| Address |
Physiotherapy School and Centre, Seth G.S Medical College and
KEM Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Gore |
| Designation |
Additional Professor |
| Affiliation |
Physiotherapy School and Centre, Seth G.S Medical College and KEM Hospital, Mumbai |
| Address |
Physiotherapy School and Centre, Seth G.S Medical College and
KEM Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy School and Centre, Seth G.S. Medical College and KEM Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Yash Shinde |
| Address |
402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, Dr Ernest Borges Road, opposite Tata Memorial Hospital, Parel, Mumbai |
| Type of Sponsor |
Other [Self funded student study] |
|
|
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 Archana Gore |
Seth G.S Medical College and KEM Hospital |
OPD No. 6, Physiotherapy Department, Orthopaedic Centre Building, KEM Hospital, Parel, Mumbai - 400012
Mumbai
MAHARASHTRA |
9082621220
nilarch17@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Seth G. S Medical College and KEM Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
360 Degree Virtual Reality Video-viewing |
The video presentation will be given to the participants using a head-mounted display (Irusu Play VR). A 40 second gait video of a healthy individual will be recorded using a 360 degree camera (Insta 360 One RS) at an appropriate walking speed of 0.8 - 1m/s based on average gait speed in stroke individuals. The 360 degree field of view gait video will be shot in OPD area by professional filming personnel. It will be filmed in the OPD corridor within institute premises.
Day 1 –
-Screening of individuals with stroke will be done with above explained methods in physiotherapy OPD unit.
-After screening, participants will be briefed about the nature and purpose of the study, its procedure and a written consent will be taken. The data will be collected from individuals who meet the
inclusion and exclusion criteria will be included in the study and requested for a follow-up.
-To minimize the risk of any VR sickness, short stints of VR
intervention with breaks will be given. Patients will also be requested to come for the follow-up hydrated, preferably after a light meal. Its best that the learner takes the position they’re visualizing in the headset i.e. standing.
Day 2 –
-Assessment of baseline parameters of gait will be done using Wisconsin Gait Scale (WGS) and the Single limb stance test (SLT). Participant may use orthoses.
Theyll be observed while walking for movement analysis.
-Participants will then be given conventional rehab for approx 45 mins
-Assessment of pre-intervention parameters of gait will be done using the WGS and SLT
-To ensure that environment is familiar, the 360 degree presentation will be filmed at the same location where the participants will perform the walking test
-To experience the presentation, participants will be secured safely with a harness rope, requested to stand, and fit with head-mounted VR goggles. To make the most of the immersive features of VR, the screening will be with the patient facing down, observing the movement of legs presented, the 40 second 360 degree
walking video being played 3 times, a total of 2 minutes, followed by a 5-minute break to avoid any motion sickness
-After experiencing the presentation, a brief walking practice will be given with verbal cues for 2 minutes
-After taking a rest, they will again be given the walking presentation, in the same position i.e. standing
-The participants will then be asked to walk, be observed and post-intervention assessment using WGS and SLT will be done.
-The collected data will be tabulated and analyzed using Microsoft Excel and SPSS v26. The difference between pre-intervention and post-intervention gait parameters will be calculated and their clinical significance will be investigated.
-The statistical analysis will be carried out by checking the values of WGS Score and Single limb stance test for normality and using an appropriate test to compare and find significance of pre-post total score and sub items of WGS and SLT |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Stroke patients between the ages of 30 to 60 who are medically stable
Patients of both genders with incidence of first stroke
Ambulatory hemiparetic patients
Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment (MMSE score less than 18)
Severe forms of unilateral spatial neglect, screened using the Bell’s Test (cut off score more than or equal to 50 percent)
Severe ideomotor apraxia screened using the Apraxia Screen of TULIA (AST) (cut off score less than 5)
Severe anosognosia screened using the Visual-
Analogue Test Assessing Anosognosia for Motor Impairment (VATA-M) (cut off score for lower limb more than or equal to +6)
Severe visual field of view deficits screened using
Confrontation Visual Fields method
VAS for pain during ambulation is more than 4
Drug resistant epilepsy or hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Wisconsin Gait Scale (WGS)
2) Single Limb Stance Time (SLT) |
1. Baseline
2. Pre-intervention
3. Post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="0"
Months="10"
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
|
Stroke can lead to severe physical dysfunction of limbs, impaired balance, cognition and sensation which leads to functional limitations and disabilities.
Gait re-training after a stroke requires constant, reinforced real-world like environmental conditions and situations during training. Virtual reality is used to artificially stimulate visual and proprioceptive information by providing an immersive experience.
Movements practiced in such a virtual environment that closely mimics real-world tasks have been shown to maximize the effects of training which is an advantage of VR therapy.
The purpose of this study is therefore to give stroke patients an immersive 360° VR experience of walking that is more correct than their present activity pattern and ascertain its immediate effect on improving gait may also be more feasible to practice in clinical setting.
It is one-time experimental study requiring a total of 1 or 2 routine visits in which participants will be screened and evaluated for 10-15 minutes and VR treatment will take 15-20 minutes. Sample size of the study is 30 participants who will come routinely to neuro physiotherapy rehabilitation OPD.
If they agree to give consent to participate in this study, they will be asked about a) previous medical and surgical history, current health status and medications. b) undergo a brief physical examination i.e. observational gait analysis and one leg stance time.
The study staff will review the results of these evaluation and test. If you are eligible to participate you will be taken in the study. In that visit pre-evaluation of observational gait analysis and one leg stance time. 360° VR video-viewing treatment will be given via a head-mount VR headset, for total of 2 minutes, twice. Post intervention evaluation of gait parameters and single leg stance time will be done.
The collected data will be tabulated and analyzed using Microsoft Excel and SPSS version 26 (IBM). The difference between pre-intervention and postintervention gait parameters will be calculated and their clinical significance will be investigated.
The statistical analysis will be carried out by first checking the values of WGS Score and Single limb stance test parameters for normality. Normality of the data will be checked. Depending on normality, Paired T Test (Parametric) or Wilcoxon Signed Rank test (non-parametric) will be used to compare pre post total score, sub scales and sub items of Wisconsin Gait Scale and the Single Limb Stance time. |