| CTRI Number |
CTRI/2025/11/098068 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Cognitive and Physical functions in older adults through indian folk games |
|
Scientific Title of Study
|
Effects of Indian folk games on cognition, coordination, balance, and quality of life in elderly -A randomised controlled 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 |
Ashwini SN |
| Designation |
Assistant professor |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced physiotherapy Centre, room number 39, Department of neurological physiotherapy, Sagar floor, KLE, Dr Prabhakar Kore Hospital and medical research Centre
Belgaum
KARNATAKA
590010
India |
| Phone |
6360378795 |
| Fax |
|
| Email |
ashwinijain@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwini SN |
| Designation |
Assistant professor |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced physiotherapy Centre, room number 39, Department of neurological physiotherapy, Sagar floor, KLE, Dr Prabhakar Kore Hospital and medical research Centre
KARNATAKA
590010
India |
| Phone |
6360378795 |
| Fax |
|
| Email |
ashwinijain@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shardul Patil |
| Designation |
intern |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced physiotherapy Centre, room number 39, Department of neurological physiotherapy, Sagar floor, KLE, Dr Prabhakar Kore Hospital and medical research Centre
Belgaum
KARNATAKA
590010
India |
| Phone |
7058404237 |
| Fax |
|
| Email |
shardulp2002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KAHER institute of physiotherapy |
| Address |
Advanced physiotherapy Centre, room number 39, Department of neurological physiotherapy, Sagar floor, care, Dr Prabhakar Kore Hospital and medical research Centre, Belgaum, Karnataka, 590010 |
| Type of Sponsor |
Private medical 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 |
| DrShardul Patil |
KAHER Institute of Physiotherapy |
Advanced physiotherapy centre ,Room no. 39, Department of Orthopaedic manual therapy ,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre , Belgaum , Karnataka ,590010
Belgaum
KARNATAKA |
7058404237
shardulp2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICAL COMMITTEE KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
five stones (knuckle bones),Pushampa(statue games) Arm wrestling, Lemon and spoon
astha chamma (indian ludo) |
These games improve cognition, balance, coordination in elderly population and improve quality of life
Duration :2 weeks |
| Comparator Agent |
Frankels exercise ,Flexiblity exercise ,Balance exercise. |
Stretching of Calf,hamstrings quadricipes,,hip flexors& hip adductors
Stepping in all directions, reaching to the limits of stability in different position
Standing on hard surface and home surface step up and down, tandem standing and walking,single
limb standing (eyes open and eyes closed)
Duration: 2 weeks
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age 60 to 85 years male and female
Participant with MOCA scale score of 18 to 25 mild 10to17 moderate cognitive impairment
BERG BALANCE scale score of 41 to 56 risk of fall
SARA scale score of 1 to 15 out of 40 incoordination
Functional mobility sufficient to participate in group based folk games: able to stand and walk for at least 10 mins
|
|
| ExclusionCriteria |
| Details |
Participants diagnosed with any neurological disorders, recent fractures
Unstable cardiovascular or pulmonary disease e.g unstable angina recent myocardial infarction within 3 months, uncontrolled heart failure that makes participation unsafe.
Complete Vision and auditory impairment
Participation in another clinical trial or structured cognitive/motor intervention program during the study period.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
SARA scale (Scale for assessment rating of ataxia)
MOCA (The Montreal Cognitive Assessment scale)
WHOQOL-BREF Scale |
Berg Balance Scale
SARA scale (Scale for assessment rating of ataxia)
Before and After intervention(2 weeks)
MOCA (The Montreal Cognitive Assessment scale)
WHOQOL-BREF Scale |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
The study titled “Effect of Indian Folk Games on Cognition, Coordination, Balance and Quality of Life in Elderly: A Randomized Controlled Trial” aims to evaluate the effectiveness of traditional Indian folk games as a therapeutic intervention in the elderly population. With aging, there is a progressive decline in cognition, coordination, and balance, leading to reduced independence and quality of life. Indian folk games are culturally rooted, enjoyable, and promote both physical and mental engagement, making them a feasible and low-cost alternative to conventional rehabilitation.This randomized controlled trial will include 36 participants aged 60–85 years from old age homes in Belagavi, Karnataka, divided equally into experimental and control groups. The experimental group will participate in selected folk games for two weeks. Outcomes will be measured using MoCA (cognition), SARA (coordination), BBS (balance), and WHOQOL-BREF (quality of life).The study hypothesizes that participation in Indian folk games will significantly improve cognitive function, coordination, balance, and quality of life among elderly individuals. |