| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [SUJINLAZAR3@GMAIL.COM].
- 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.
- 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. |