| CTRI Number |
CTRI/2024/08/072226 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Effect of Rhythmic Music Beats on Walking Speed in Elders with Balance Problems |
|
Scientific Title of Study
|
Effect of Rhythmic Auditory Stimulation(RAS) on gait speed in elderly with balance impairment : A Randomized 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 |
Mohammed Jassim K J |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
MPT 2nd year classroom,
MPT Division,
Physiotherapy department, Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA 575018 India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633326754 |
| Fax |
|
| Email |
jazimjunaidofficial@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smitha D |
| Designation |
AdditionalProfessor, |
| Affiliation |
Yenepoya University |
| Address |
Vice principal room,
Staff Division,
Physiotherapy department,
Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA 575018 India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886318394 |
| Fax |
|
| Email |
smithad@yenepoya.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Jassim K J |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
MPT 2nd year classroom,
MPT Division
Physiotherapy department,
Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA 575018 India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633326754 |
| Fax |
|
| Email |
jazimjunaidofficial@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Source,
Yenepoya Medical College Hospital (YMCH) |
|
|
Primary Sponsor
|
| Name |
Mohammed Jassim K J |
| Address |
Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA 575018 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohammed Jassim K J |
Olavinahalli |
Olavinahalli
Dakshina Kannada
KARNATAKA |
9633326754
jazimjunaidofficial@gmail.com |
| Mohammed Jassim K J |
Yenepoya Medical College hospital (YMCH) |
Deralakatte
Dakshina Kannada
KARNATAKA |
9633326754
jazimjunaidofficial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee - 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R54||Age-related physical debility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Conventional Physiotherapy including General conditioning exercise for 4 weeks. |
| Intervention |
Rhythmic Auditory stimulation(RAS) |
Participants will walk on a flat indoor path with Rhythmic Auditory Stimulation (RAS) for 20 minutes provided by using a digital musical instrument for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Able to follow simple commands
Balance impairment as assessed by Timed up and go test with time 13.5 or above
Normal hearing or corrected hearing
Normal vision or corrected vision
|
|
| ExclusionCriteria |
| Details |
Able to follow simple commands
Balance impairment as assessed by Timed up and go test with time 13.5 or above
Normal hearing or corrected hearing
Normal vision or corrected vision
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 10m Walk Test |
Baseline, After 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2024 |
| 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
|
Not yet recruiting |