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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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