| CTRI Number |
CTRI/2026/03/105179 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Game-Based Wobble Board Training and Standard Wobble Board Training to Improve Balance and Mobility in Stroke Patients. |
|
Scientific Title of Study
|
Effect of Wobble Board Therapeutic Exergaming Vs Standard Wobble Board Training on Balance, Limits of Stability and Functional Mobility in Stroke Patients-An Experimental 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 |
Mrunalini Patil |
| Designation |
MPT Scholar |
| Affiliation |
KJ Somaiya College Of Physiotherapy |
| Address |
KJ Somaiya College Of PhysiotherapY, Neurophysiotherapy Department Ayurvihar Complex, Eastern Express Highway, Sion East, Sion, Mumbai.
Mumbai (Suburban) MAHARASHTRA 400022 India |
| Phone |
9673361900 |
| Fax |
|
| Email |
patilmrunalini85@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Priti Agni |
| Designation |
PHD Scholar, Associate Professor, Neurophysiotherapy Department |
| Affiliation |
KJ Somaiya College Of Physiotherapy |
| Address |
KJ Somaiya College Of PhysiotherapY, Neurophysiotherapy Department Ayurvihar Complex, Eastern Express Highway, Sion East, Sion, Mumbai.
Mumbai (Suburban) MAHARASHTRA 400022 India |
| Phone |
9673361900 |
| Fax |
|
| Email |
pritiagni@somaiya.edu |
|
Details of Contact Person Public Query
|
| Name |
Priti Agni |
| Designation |
PHD Scholar, Associate Professor, Neurophysiotherapy Department |
| Affiliation |
KJ Somaiya College Of Physiotherapy |
| Address |
KJ Somaiya College Of PhysiotherapY, Neurophysiotherapy Department Ayurvihar Complex, Eastern Express Highway, Sion East, Sion, Mumbai.
MAHARASHTRA 400022 India |
| Phone |
9673361900 |
| Fax |
|
| Email |
pritiagni@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya College Of Physiotherapy,Eastern Express Highway,Sion east,Sion,Mumbai,Maharashtra,Pincode-400022 |
|
|
Primary Sponsor
|
| Name |
Mrunalini Patil |
| Address |
KJ Somaiya College Of PhysiotherapyAyurvihar Complex, Eastern Express Highway, Sion East, Sion, Mumbai, Maharashtra 400022 |
| 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 Mrunalini Patil |
KJ Somaiya College Of Physitherapy |
Neurophysiotherapy Department, Ayurvihar Complex, Eastern Express Highway,Sion ,Mumbai- 400022
Mumbai(Suburban)
MAHARASHTRA Mumbai (Suburban) MAHARASHTRA |
9673361900
patilmrunalini85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,KJ Somaiya College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Wobble Board |
The control group will receive Standard Wobble Board Training, consisting of conventional balance exercises such as standing, weight shifting, and controlled tilting on a wobble board for 15 minutes per session along with standard physiotherapy exercises, once daily, 5 days a week, for 2 weeks duration. |
| Intervention |
Wobble Board Therapeutic Exergaming |
A therapeutic exergaming system utilizing a wobble board has been developed for balance and postural stability training. The wobble board is embedded with an inertial motion-tracking sensor that detects body movement and provides real-time feedback. It connects wirelessly via Bluetooth to a tablet, allowing patients to interact with on-screen game tasks by tilting the board in different directions. Balance training using a wobble board with exergame feedback, will be given for 15 minutes per session along with standard physiotherapy exercises, once daily for 5 days a week, for 2 weeks duration.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1)Early 8 days-3 months and late subacute 4-6 months and chronic from 6 months onwards stroke patients
2)Individuals of all genders between the age group 18- 59 years with first episode of unilateral stroke
3)Functional ambulatory category grade greater than or equal to 2
4)Mini Mental State Examination score greater than or equal to 24 |
|
| ExclusionCriteria |
| Details |
1.Individuals with lower-limb impairment caused by other diagnosed neurological (other than stroke) or musculoskeletal diseases.
2.Individuals with diagnosed psychiatric conditions, perceptual disorders and/ or uncorrected visual /auditory impairments.
3.Individuals with uncontrolled hypertension/diabetes.
4.Individuals with diagnosed uncontrolled cardiopulmonary diseases.
5.Individuals not giving consent.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Balance will be assessed by Berg Balance Scale & Limits of stability will be assessed by Multidirectional Reach Test
Functional Mobility will be assessed by TUG Test
|
Baseline assessment of outcome measures will be conducted prior to the intervention, and post-intervention assessment will be performed after 2 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
12/03/2026 |
| 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="6" 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
|
Stroke often leads to impaired balance, reduced limits of stability and decreased functional mobility, increasing fall risk and dependency in daily activities. Conventional balance training methods, though beneficial, may lack engagement and real-time feedback. Exergaming integrates physical activity with interactive gaming, providing visual biofeedback to enhance motivation, postural control, and motor learning. This experimental study aims to compare the short-term effects of wobble board therapeutic exergaming versus standard wobble board training on balance, limits of stability, and functional mobility in stroke patients. Thirty-six participants aged 18–59 years with unilateral stroke will be randomly allocated into two groups. The experimental group will receive wobble board therapeutic exergaming with standard physiotherapy, while the control group will undergo standard wobble board balance training with the same physiotherapy regimen. Both interventions will be delivered 5 sessions per week for 2 weeks. Outcome measures include the Berg Balance Scale (BBS), Multidirectional Reach Test (MDRT), and Timed Up and Go (TUG) test, assessed pre- and post-intervention. The study aims to provide evidence on the effectiveness of exergaming-based wobble board training as an engaging and effective approach to improve balance and functional mobility in stroke rehabilitation. |