| CTRI Number |
CTRI/2025/08/092568 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of video game based balance board exercises and regular balance board exercises on improving balance in older adults living in community. |
|
Scientific Title of Study
|
Effect of Exergaming Wobble Board Training Vs Conventional Wobble Board Training on Balance in Community Dwelling Older Adults: 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 |
Dishi Trivedi |
| Designation |
MPT Scholar |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy Neuro Physiotherapy Department Ayurvihar Complex Eastern Express Highway Sion Mumbai
Mumbai (Suburban) MAHARASHTRA 400022 India |
| Phone |
7208609553 |
| Fax |
|
| Email |
dishitrivedi19@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mugdha Oberoi |
| Designation |
Assistant Professor |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy Neuro Physiotherapy Department Ayurvihar Complex Eastern Express Highway Sion Mumbai
Mumbai (Suburban) MAHARASHTRA 400022 India |
| Phone |
9820585119 |
| Fax |
|
| Email |
mugdha@somaiya.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Mugdha Oberoi |
| Designation |
Assistant Professor |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy Neuro Physiotherapy Department Ayurvihar Complex Eastern Express Highway Sion Mumbai
MAHARASHTRA 400022 India |
| Phone |
9820585119 |
| Fax |
|
| Email |
mugdha@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya College of Physiotherapy, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai- 400022 |
|
|
Primary Sponsor
|
| Name |
Dishi Trivedi |
| Address |
KJ Somaiya College of Physiotherapy, Neuro Physiotherapy Department, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai |
| 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 Dishi Trivedi |
KJ Somaiya College of Physiotherapy |
KJ Somaiya College of Physiotherapy, Neuro Physiotherapy Department, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai-400022 Mumbai (Suburban) MAHARASHTRA |
7208609553
dishitrivedi19@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 |
| Healthy Human Volunteers |
60-80 year old Community Dwelling Elderly, All genders, MMSE more than 24, POMA score more than 19 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Wobble Board Training |
Each subject will be given a session for 40 mins, 5
sessions for 2 weeks.
Warm up exercises will be given for 10mins followed by wobble board training- Anterior – posterior tilt, Medial- Lateral tilt, Anteromedial- posterolateral tilt, Anterolateral- Posteromedial tilt.
Each will be given for 5 mins, total 20 mins followed by cool down for 10 mins |
| Intervention |
Exergaming Wobble Board Training |
Each subject will be given a session for 40 mins, 5
sessions for 2 weeks
Warm exerises for 10 mins followed by Star Boat and Space Invasion games for 10 mins each followed by cool down for 10 mins |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
60-80 year old community dwelling elderly willing to participate, able to
understand English language and follow instructions with MMSE score
more than 24, Individuals with all genders and POMA – Score more than 19 (low
to moderate risk of fall). |
|
| ExclusionCriteria |
| Details |
1.Individuals with uncorrected visual or auditory impairment.
2. Use of walking aid or orthosis
3.Individuals with surgical, traumatic, inflammatory, and any
musculoskeletal condition.
4. Individuals with unstable angina.
5. Any neurological conditions.
6. Individual with vestibular dysfunction, including vertigo.
7. Individual with a history of hospitalisation in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unipedal stance test, Multidirectional reach test, Sensor based balance evaluation |
Baseline and post 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
02/09/2025 |
| 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="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
|
|