| CTRI Number |
CTRI/2025/11/097857 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of music on movement and balance in elderly |
|
Scientific Title of Study
|
Immediate Effects of Up Tempo vs Down Tempo Music-Based Internal Cueing On Functional Mobility And Balance In Elderly |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha rathod |
| Designation |
postgraduate student |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
Ramaiah college of physiotherapy, MSR college road, MSR nagar, MSRIT post, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9892602227 |
| Fax |
|
| Email |
disha02227@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Debur |
| Designation |
Professor- M S Ramaiah college of Physiotherapy |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
Ramaiah college of physiotherapy, MSR college road, MSR nagar, MSRIT post, Bengaluru 560054
KARNATAKA
560054
India |
| Phone |
9845544848 |
| Fax |
|
| Email |
rameshdebur.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Disha rathod |
| Designation |
postgraduate student |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
Ramaiah college of physiotherapy, MSR college road, MSR nagar, MSRIT post, Bengaluru-560054
KARNATAKA
560054
India |
| Phone |
9892602227 |
| Fax |
|
| Email |
disha02227@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah college of physiotherapy, MSR nagar, MSRIT post, bangalore-560054 |
|
|
Primary Sponsor
|
| Name |
Disha Rathod |
| Address |
Ramaiah college of physiotherapy, MSR nagar, MSRIT post, Bangalore-560054 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Disha Rathod |
Ramaiah medical hospital |
M S Ramaiah college of physiotherapy, M S Ramaiah nagar, MSRIT Post, bangalore-560054
Bangalore
KARNATAKA |
9892602227
disha02227@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commitee M S Ramaiah medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impaired balance individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
musical metronome |
using a musical metronome for internal cueing with modulated tempo to examine effects on functional mobility and balance. |
| Comparator Agent |
musical metronome |
using a musical metronome for internal cueing with non- modulated tempo to examine effects on functional mobility and balance. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 60 to 80 years
2. Independent ambulation of at least 10 meters without assisted devices
3. TUG score greater than 12s
4. Consent to participate |
|
| ExclusionCriteria |
| Details |
1. Diagnosed neurological disorders (such as Parkinson’s disease, Alzheimer’s
disease, Stroke, Peripheral neuropathy)
2. Diagnosed Musculoskeletal conditions (such as Arthritis, Chronic pain of
lower extremity, recent fractures)
3. Severe cognitive impairment( Montreal Cognitive Assessment score less than ten )
4. Diagnosed hearing or vision impairment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed Up and go test |
immediate effects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Four Square Step Test & Single Leg Stance |
immediate effects |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
25/12/2025 |
| 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="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 - NO
|
|
Brief Summary
|
This study titled Immediate Effects of Up-Tempo vs Down-Tempo Music-Based Internal Cueing on Functional Mobility and Balance in Elderly is a Randomised controlled trial aimed at examining the immediate effects of mental singing using music of varying tempos on balance and mobility in older adults. Thirty-two community-dwelling elderly individuals aged 60–80 years with balance deficits (TUG score greater than 12s) will be randomly allocated into intervention (up-tempo or down-tempo) and placebo (baseline tempo) groups using computer-generated randomization with sealed opaque envelope concealment. Participants will engage in 10 minutes of seated mental singing of Sargam—first listening through headphones and then continuing mentally—followed by assessment of functional mobility and balance using the Timed Up and Go Test, Four Square Step Test, and Single Leg Stance Test. The study seeks to determine whether internal cueing with different musical tempos can produce immediate, measurable improvements in postural control and mobility among older adults. |