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CTRI Number  CTRI/2026/02/104669 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To compare virtual reality games and conventional therapy for improving bilateral coordination among persons in acute stroke 
Scientific Title of Study   Effects of of Nintendo Wii fit balance board virtual reality games as compared with standard of care for improving bilateral coordination among individuals with acute stroke treated at tertiary care institute in South Kerala 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujin Stephanas Lazar 
Designation  Associate Professor 
Affiliation  Dr SMCSI MEDICAL COLLEGE AND HOSPITAL,KARAKONAM 
Address  Dr.S.M.C.S.I Medical College & Hospital Department of Physiotherapy Karakonam P.O Thiruvananthapuram, Kerala South India Pin - 695504

Thiruvananthapuram
KERALA
695504
India 
Phone  7094425626  
Fax    
Email  SUJINLAZAR3@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Aliver Justin 
Designation  Professor 
Affiliation  Dr SMCSI MEDICAL COLLEGE AND HOSPITAL,KARAKONAM 
Address  Dr.S.M.C.S.I Medical College & Hospital Karakonam P.O Thiruvananthapuram, Kerala South India Pin - 695504
Dr.S.M.C.S.I Medical College & Hospital Karakonam P.O Thiruvananthapuram, Kerala South India Pin - 695504
Thiruvananthapuram
KERALA
695504
India 
Phone  7094425626  
Fax    
Email  sujinlazar3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sujin Stephanas Lazar 
Designation  Associate Professor 
Affiliation  Dr SMCSI MEDICAL COLLEGE AND HOSPITAL,KARAKONAM 
Address  Dr.S.M.C.S.I Medical College & Hospital Depatment of physiotherapy Karakonam P.O Thiruvananthapuram, Kerala South India Pin - 695504

Thiruvananthapuram
KERALA
695504
India 
Phone  7094425626  
Fax    
Email  SUJINLAZAR3@GMAIL.COM  
 
Source of Monetary or Material Support  
Dr.Somervell Memorial Medical College and Hospital,Karakonam,Trivandrum Dist,Kerala  
 
Primary Sponsor  
Name  Sujin Stephanas Lazar 
Address  Dr SMCSI Medical College and Hospital,Karakonam PO Pin code :695504 
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 Sujin Stephanas Lazar  Dr SMCSI Medical College and Hospital  Department of Physiotherapy Karakonam P.O Thiruvananthapuram, Kerala South India Pin - 695504
Thiruvananthapuram
KERALA 
7094425626

SUJINLAZAR3@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics comitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard conventional acute stroke physiotherapy   30 minutes/session, 3 sessions/week, for 4 weeks (total 12 sessions)  
Intervention  nintendo wii fit balance board virtual reality games  30 minutes/session, 3 sessions/week, for 4 weeks (total 12 sessions)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Adults aged greater than 18 years admitted with first-ever or recurrent ischemic or hemorrhagic stroke confirmed by neuroimaging.
2)In the acute phase: within 7–21 days post-stroke at time of recruitment.
3)Able to follow simple verbal commands (MOCA), done by the primary investigator.
4)Medically stable and cleared by physician for standing/weight-shifting activities.
5)Able to stand (with or without assistance) for greater than 1 minute or sit-to-stand with minimal assistance
 
 
ExclusionCriteria 
Details  o Severe cognitive, visual or perceptual deficits preventing participation (e.g., severe hemi spatial neglect).
o Severe lower-limb musculoskeletal conditions that limit safe participation.
o Unstable cardiac status or other contraindications to moderate physical activity.
o Pre-existing neurological disease affecting coordination (e.g., advanced Parkinson’s).
o Participation in other interventional trials targeting balance/coordination
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Bilateral coordination  four weeks, six weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Balance  four weeks,six weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   10/03/2026 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [SUJINLAZAR3@GMAIL.COM].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Stroke continues to be a major public health challenge in India, particularly in Kerala, where the prevalence and incidence are higher than the national average due to lifestyle and demographic factors(10). A significant proportion of stroke survivors experience long-term motor impairments, including deficits in bilateral coordination, which limit their ability to perform activities of daily living independently. Effective rehabilitation is therefore essential to reduce disability, improve quality of life, and decrease the socioeconomic burden of stroke.

 

Conventional physiotherapy remains the standard of care for stroke rehabilitation, focusing on repetitive exercises, balance training, and functional re-education. While effective, these approaches may lack the motivational and engaging elements required to sustain patient adherence, particularly in the acute phase of recovery. Moreover, the resource-intensive nature of traditional rehabilitation can sometimes limit its scalability and accessibility.

 

Emerging evidence suggests that virtual reality (VR)-based interventions, such as those provided by the Nintendo Wii Fit Balance Board, can complement and enhance traditional therapy. In this context, virtual reality (VR)-based interventions—such as the Nintendo Wii Fit Balance Board—offer a novel, interactive solution. These systems combine gamified exercises with real-time feedback, encouraging active participation and stimulating bilateral motor activity. The Wii Fit Balance Board, in particular, has shown promise in improving balance, coordination, and motivation among neurological patients, making it a viable adjunct to conventional therapy.

 

VR-based rehabilitation creates immersive, interactive, and feedback-driven environments that not only promote motor learning and neuroplasticity but also improve patient motivation and participation. The balance board specifically targets postural control and coordination, which are crucial for bilateral motor recovery. Its affordability and ease of use also make it a viable option for integration into clinical practice in resource-limited settings.

 

Despite promising findings from international studies, there is a lack of region-specific research evaluating the effectiveness of Nintendo Wii Fit Balance Board games in stroke rehabilitation in India, particularly in South Kerala, where the stroke burden is notably high. Conducting this study will help generate evidence on whether VR- based rehabilitation provides superior outcomes in improving bilateral coordination compared to the standard of care. The findings may guide clinical decision-making, support cost-effective innovations in therapy, and contribute to developing patient-centered rehabilitation protocols in tertiary care institutes.

 

Investigating the effects of Wii Fit Balance Board VR games on bilateral coordination in acute stroke patients is therefore justified. This study could provide evidence for incorporating such technology into early


rehabilitation programs, potentially improving recovery outcomes, increasing patient motivation, and reducing long-term disability.

 

This study is grounded in the need to explore cost-effective, engaging, and scalable rehabilitation strategies that can be integrated into standard care. By comparing the effects of Wii Fit Balance Board VR games with traditional physiotherapy, the research aims to generate evidence that could inform nursing protocols, enhance patient outcomes, and support the adoption of technology-driven rehabilitation in resource-limited settings.

 
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