| CTRI Number |
CTRI/2025/08/092900 [Registered on: 12/08/2025] 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
|
Comparing Video Game Exercises to Traditional Balance Training for Improving Balance in Older Adults" |
|
Scientific Title of Study
|
EXERGAMING VERSUS CONVENTIONAL BALANCE EXERCISES ON BALANCE COMPROMISED GERIATRIC POPULATIONS: A RANDOMIZED CLINCAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
THANSIL M S |
| Designation |
PG STUDENT (MPT NEUROPHYSIOTHERAPY) |
| Affiliation |
CAUVERY COLLEGE OF PHYSIOTHERAPY MYSORE. |
| Address |
MPT,ROOM NO 1, DEPARTMENT OF NEUROLOGICAL SCIENCE FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPY, KBL LAYOUT NEAR DEVEGOWDA CIRCLE ,MYSORE MPT, DEPARTMENT OF NEUROLOGICAL SCIENCE ROOM NO 1,FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPY ,KBL LAYOUT NEAR DEVEGOWDA CIRCLE ,MYSORE Mysore KARNATAKA 570028 India |
| Phone |
9656567522 |
| Fax |
|
| Email |
thansilthansu03@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MR.RAKESH M |
| Designation |
ASSOCIATE PROFESSOR IN NEURO PHYSIOTHERAPY DEPARTMENT |
| Affiliation |
CAUVERY COLLEGE OF PHYSIOTHERAPY MYSORE., RGUHS UNIVERSITY BANGLORE |
| Address |
MPT,ROOM NO 1, DEPARTMENT OF NEUROLOGICAL SCIENCE FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPY, KBL LAYOUT NEAR DEVEGOWDA CIRCLE ,MYSORE MPT, DEPARTMENT OF NEUROLOGICAL SCIENCE ROOM NO 1,FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPY ,KBL LAYOUT NEAR DEVEGOWDA CIRCLE ,MYSORE Mysore KARNATAKA 570028 India |
| Phone |
7795771545 |
| Fax |
|
| Email |
rakeshmanju098@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
THANSIL M S |
| Designation |
PG STUDENT(MPT NEUROPHYSIOTHERAY) |
| Affiliation |
CAUVERY COLLEGE OF PHYSIOTHERAPY MYSORE. |
| Address |
MPT,ROOM NO 1, DEPARTMENT OF NEUROLOGICAL SCIENCE FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPY, KBL LAYOUT NEAR DEVEGOWDA CIRCLE ,MYSORE MPT, DEPARTMENT OF NEUROLOGICAL SCIENCE ROOM NO 1,FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPY ,KBL LAYOUT NEAR DEVEGOWDA CIRCLE ,MYSORE Mysore KARNATAKA 570028 India |
| Phone |
9656567522 |
| Fax |
|
| Email |
thansilthansu03@gmail.com |
|
|
Source of Monetary or Material Support
|
| CAUVERY COLLEGE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
CAUVERY COLLEGE OF PHYSIOTHERAPY |
| Address |
MPT, DEPARTMENT OF NEUROLOGICAL SCIENCE,ROOM NO 1,FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPYKBL LAYOUT NEAR DEVAGOWDA CIRCLE ,MYSORE |
| Type of Sponsor |
Other [PRIVATE COLLEGE] |
|
|
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 |
| MRRAKESH M ASSOSIATE PROFESSOR |
CAUVERY COLLEGE OF PHYSIOTHERAPY OPD |
MPT, DEPARTMENT OF NEUROLOGICAL SCIENCE ROOM NO 1,FIRST FLOOR, BUILDING ONE CAUVERY COLLEGE OF PHYSIOTHERAPYKBL LAYOUT NEAR DEVAGOWDA CIRCLE ,MYSORE Mysore KARNATAKA |
7795771545
rakeshmanju098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
balance compromised geriatric populations |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL BALACE EXERCISE EXPERIMENTAL GROUP B |
Participants in the group B will perform conventional balance exercises for 8 weeks, with 3 sessions per week. Each session will last 30–40 minutes and include static and dynamic postural training, weight-shifting, tandem walking, and obstacle crossing exercises to improve balance and stability. |
| Intervention |
EXERGAMING EXPERIMENT GROUP A |
Participants in the experimental group will undergo Nintendo Wii Fit–based balance training for 8 weeks, with 3 sessions per week. Each session will last 30–40 minutes and include games targeting weight-shifting, stepping, and dynamic postural control, such as ski slalom, table tilt, and tightrope walk. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 60 and 80 years.
2.Moderate balance impairment Berg Balance Scale score 21 40.
3.Ability to walk independently or with minimal assistance.
4.Both male and female participants.
A score of greater than 23 on the Falls Efficacy Scale International FES I indicating fear
of falling.
|
|
| ExclusionCriteria |
| Details |
1.Musculoskeletal impairments.
2. Vestibular or visual deficits.
3.Inability to walk.
4. Postural hypotension.
5. Presence of pacemakers or history of seizures. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BERG BALANCE SCALE |
BASELINE DAY-0,POST INTERVENTION DAY 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FALL EFFICACY SCALE |
BASELINE DAY-0,POST INTERVENTION DAY 42 |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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)
|
22/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="15" |
|
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 - NO
|
|
Brief Summary
|
This randomized clinical trial aims to compare the effects of exergaming using the Nintendo Wii Fit balance training program and conventional balance exercises on balance and fear of falling in older adults. Participants aged 60 to 80 years with moderate balance impairment defined by a Berg Balance Scale score between 21 and 40 will be included. A total of 46 participants will be randomly allocated into two groups: an exergaming group and a conventional balance exercise group. Both groups will undergo eight weeks of supervised balance training sessions. The primary outcome measure will be improvement in balance assessed using the Berg Balance Scale, and the secondary outcome will be the reduction in fear of falling assessed using the Falls Efficacy Scale. The study aims to determine whether exergaming provides better functional balance improvement and engagement compared to conventional balance exercises in older adults. |