| CTRI Number |
CTRI/2025/08/092558 [Registered on: 06/08/2025] 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 |
Single Arm Study |
|
Public Title of Study
|
THE IMPACT OF BALANCE RHYTHMICAL TRAINING ON BALANCE, COORDINATION AND DYNAMIC GAIT INDEX IN OLDER ADULTS- A SINGLE GROUP EXPERIMENTAL STUDY |
|
Scientific Title of Study
|
The impact of Rhythmic Balance Training on Balance, Coordination, and Dynamic Gait Index in Older Adults: A Single-Group 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 |
PRIYANKA B |
| Designation |
Physiotherapist |
| Affiliation |
cauvery college of physiotherapy mysuru |
| Address |
MPT classroom 1 department of Neurological science first floor building one cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 MPT classroom 1 department of Neurological science first floor building one cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 Mysore KARNATAKA 570028 India |
| Phone |
9739255617 |
| Fax |
|
| Email |
priyankavaikar077@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rakesh M |
| Designation |
Associate professor |
| Affiliation |
cauvery college of physiotherapy mysuru |
| Address |
Department of Neurological science building one cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 Department of Neurological science building one cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 Mysore KARNATAKA 570028 India |
| Phone |
7795771545 |
| Fax |
|
| Email |
rakeshmanju098@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PRIYANKA B |
| Designation |
physiotherapist |
| Affiliation |
cauvery college of physiotherapy mysuru |
| Address |
Department of Neurological science building one cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 Department of Neurological science building one cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 Mysore KARNATAKA 570028 India |
| Phone |
9739255617 |
| Fax |
|
| Email |
priyankavaikar077@gmail.com |
|
|
Source of Monetary or Material Support
|
| cauvery college of physiotherapy KBL layout near devegowda circle mysore |
|
|
Primary Sponsor
|
| Name |
PRIYANKA B |
| Address |
MPT classroom one first floor building one department of Neurological science cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028
cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 |
| 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 |
| Rakesh M |
OPD cauvery college of physiotherapy |
cauvery college of physiotherapy kbl layout near devegowda circle mysore Mysore KARNATAKA |
7795771545
rakeshmanju098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee cauvery heart and multispeciality hospital, Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
older adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
balance rhythmical training |
warm up for 5 min, motor training, balance training, gait training and functional movements for 30 min and cool down for 10 min, treatment duration twice a week for 45 min per session for 5 weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
i. Aged 60 years and above
ii. Living functionally independently in good health and able to complete the planned exercise
program
iii. Participants with score of 20 to 30 in MMSE
iv. Participants with score of less than 45 in LEMOCOT test
v. Participants with score of less than 41 in BBS
vi. Participants with score of less than 19 in DGI |
|
| ExclusionCriteria |
| Details |
i. Acute neurological conditions.
ii. Benign or malignant neoplastic diseases
iii. Acute musculoskeletal injury
iv. Cardiac conditions
v. IIIrd or VIIIth cranial nerve impairment
vi. Any cognitive impairment
vii. Diabetic neuropathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dynamic gait index |
First week baseline, third week mid intervention and fifth week post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg balance scale |
First week baseline, third week week mid intervention & fifth week post intervention |
| LEMOCOT test |
First week baseline, third week mid week intervention & fifth week post intervention |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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)
|
09/09/2025 |
| 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="0" Months="2" 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 present study will be conducted to assess the effectiveness of Balance Rhythmical Training in improving balance, coordination, and gait in older adults. With aging, physiological and neurological changes often lead to impaired postural control and increased fall risk. The study will be conducted on 22 participants aged 60 years and above with mild balance impairments. They will undergo BRT for five weeks, receiving two sessions per week, each consisting of a warm up, motor training, and cool down phase, accompanied by rhythmic auditory cues delivered via a metronome. Outcome measures will be used namely, the Berg Balance Scale for balance, the Lower Extremity Motor Coordination Test for coordination, and the Dynamic Gait Index for gait performance. Assessments will be performed at baseline, mid intervention, and post intervention. |