| CTRI Number |
CTRI/2025/02/079855 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring the Use of Virtual Reality to Improve Balance in Patients with Brain Stroke : A Longitudinal Pilot study |
|
Scientific Title of Study
|
The Feasibility analysis of virtual reality based -Intervention for Improving balance in patients with stroke : A Longitudinal 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 |
CHINTALAPATI NAVYASRI |
| Designation |
Student |
| Affiliation |
GIMSR Medical College, GITAM University (Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM Deemed to be University, Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
09959922233 |
| Fax |
|
| Email |
navya13sri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
CHINTALAPATI NAVYASRI |
| Designation |
Student |
| Affiliation |
GIMSR Medical College, GITAM University (Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM Deemed to be University, Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
09959922233 |
| Fax |
|
| Email |
navya13sri@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anishmamaria Chungath |
| Designation |
Assistant Professor |
| Affiliation |
GIMSR Medical College, GITAM University (Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM Deemed to be University, Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530045 India |
| Phone |
9408626024 |
| Fax |
|
| Email |
achungat@gitam.edu |
|
|
Source of Monetary or Material Support
|
| GSPT, GITAM Institute of Medical Sciences and Research, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh,India. |
|
|
Primary Sponsor
|
| Name |
Chintalapati Navyasri |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM Deemed to be University, Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Anishmamaria Chungath |
GITAM institute of medical science and research |
Room number:01,department of physiotherapy,GITAM school of physiotherapy,Gandhi nagar,Rushikonda,Vishakapatnam Visakhapatnam ANDHRA PRADESH |
9408626024
achungat@gitam.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Institute of Medical Science and Research |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
virtual reality games and conventional physiotherapy exercises for stroke |
virtual games include VR Roller Coaster (360) and Beatbox Buster VR and the conventional physiotherapy exercises include Bed mobility exercises, Normalize the muscle tone by – facilitatory and inhibitory techniques , Weight-bearing exercises for the upper limb, Range of motion exercises (passive, active-assisted, and active) , Stretching exercises for upper limb, lower limb, and trunk musculature, Grip strength training, Coordination and balance training, Gait training, initially with mobility aids and parallel bar training later progressing to independent walking , Functional training, Electrophysical modalities as required (Electrical stimulation, thermal agents, etc.)
This intervention will be given to the patient from the day of allocation till the discharge.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are medically diagnosed with stroke and medically stable, Patients without any cognitive impairment (Mini-Mental State Examination Score - 25 and above, Patients with Berg Balance Score - 20 and above |
|
| ExclusionCriteria |
| Details |
Patients who have any other coexisting neurological conditions, Individuals who have a history of seizures, Individuals with significant visual impairments, Patients with lower limb impairments not related to stroke |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Suitability Evaluation Questionnaire (SEQ) for Virtual Rehabilitation System |
1 - At the time of discharge of the patient the Suitability Evaluation Questionnaire for Virtual Rehabilitation System |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg-balance scale, Tinetti balance assessment tool & timed up & go |
3-time points
All the 3 outcomes will be measured at the time of allocation & after one week of treatment again the outcome will be measured & also at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
20/02/2025 |
| 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
|
Based on the literature that is reviewed it is found that exercise-based conventional training may be combined with alternate training methods to improve balance and virtual reality is beneficial compared to conventional therapies because it allows for intensive repetition activities. Patients with stroke often experience balance issues affecting independence and quality of life. Advancements in Virtual reality (VR) technology spread globally, but VR’s adaptation in India is lagging compared to other countries. There should be more research literature on VR interventions and their feasibility in India. This study is designed to investigate the feasibility of Virtual reality (VR) interventions along with conventional physiotherapy for balance improvement in stroke patients in the Indian population. Participants will be screened based on the inclusion and exclusion criteria. Later the participants will be thoroughly informed about the study and informed consent will be obtained from the participants. After recruiting the participants, a thorough neurological assessment will be taken along with the outcome measures like the Berg-balance scale (BBS), and Tinetti balance assessment tool, and timed up and go to establish the baseline measurement. Later the intervention comprises both conventional therapy and virtual reality therapy will be given until the patient’s discharge. Before the discharge of the participants, the Suitability Evaluation Questionnaire for Virtual Rehabilitation Systems (SEQ) will be assessed by the patient either by self-reported or interview-based, and the Berg-balance scale (BBS), Tinetti balance assessment tool and timed up-and-go outcome measure will be measured.
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