| CTRI Number |
CTRI/2025/12/099421 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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 the Effect of Backward Walking with and without the use of Rhythmic Auditory Beats on Balance in Older Adults |
|
Scientific Title of Study
|
Comparison of the Effect of 4-week Retro Walking Training Program with and without Rhythmic Auditory Cueing on Balance in 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 |
Himani Parekh |
| Designation |
PG Student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8692096130 |
| Fax |
|
| Email |
himaniparekh2306@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Pimpale PT |
| Designation |
Professor and Head of Department, Department of Neurosciences |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9082194223 |
| Fax |
|
| Email |
dr.satishpimpale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Pimpale PT |
| Designation |
Professor and Head of Department, Department of Neurosciences |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar
MAHARASHTRA
410210
India |
| Phone |
9082194223 |
| Fax |
|
| Email |
dr.satishpimpale@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar- 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar- 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himani Parekh PT |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar- 410210
Raigarh
MAHARASHTRA |
8692096130
himaniparekh2306@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee (Academic) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older adults who are at a medium to high risk of fall, assessed using Berg Balance Scale. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Retro Walking with Rhythmic Auditory Cueing |
Group 2: Retro Walking with Rhythmic Auditory Cueing
The subjects will undergo training for 30 minutes/ session, for 3 days/ week for 4 weeks. |
| Comparator Agent |
Retro Walking without Rhythmic Auditory Cueing |
Group 1: Retro Walking without Rhythmic Auditory Cueing
The subjects will undergo training for 30/ session, for 3 days/ week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals above the age of 65 years
2) Both males and females
3) Can walk independently with or without the use of walking aids.
4) BBS score less than or equal to 40 (i.e., medium and high fall risk)
|
|
| ExclusionCriteria |
| Details |
1) Individuals who have been diagnosed with any major neurological, cardiovascular, musculoskeletal, vestibular or rheumatologic disease due to which they are restricted to the bed or immobile or wheelchair bound.
2) Individuals diagnosed with any hearing impairments who are not using hearing aids.
3) Individuals with visual impairments who are not using any corrective aids.
4) Individuals with acute lower limb injury or surgery. (less than or equal to 6 weeks) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale (BBS) and 3-m Backward Walk Test (3MBWT) |
1 month |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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
|
This study will compare the effect of Retro Walking Training with and without Rhythmic Auditory Cueing on Balance in Older Adults. The subjects will be randomly divided into two groups. Group 1 will undergo Retro Walking without Rhythmic Auditory Cueing and Group 2 will undergo Retro Walking Training with Rhythmic Auditory Cueing. The outcome measures which will be used are Berg Balance Scale (BBS) and 3-m Backward Walk Test (3MBWT). Both groups will undergo training for 30 minutes/ session for 3 days/ week for 4 weeks. |