| CTRI Number |
CTRI/2025/10/095973 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Studying the effect of dual tasking on rhythmic beats versus only dual tasking on cognition in chronic stroke population |
|
Scientific Title of Study
|
The added effect of auditory motor synchronisation training combined with cognitive motor dual task training versus cognitive motor dual task training alone on cognitive function in individuals with chronic stroke: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 |
Shruti Zungare |
| Designation |
MPT student |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
ANR OPD ,Neurophysiotherapy department
Eastern Express Highway, Sion East, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8855990173 |
| Fax |
|
| Email |
shzungare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Geeta Bhatt |
| Designation |
Head of the department |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
ANR OPD , Neurophysiotherapy department
Eastern Express Highway, Sion East, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8855990173 |
| Fax |
|
| Email |
geeta.bhatt@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Zungare |
| Designation |
MPT student |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
ANR OPD , Neuro physiotherapy department
Eastern Express Highway, Sion East, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8855990173 |
| Fax |
|
| Email |
shzungare@gmail.com |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya College of Physiotherapy
Somaiya Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra 400022 |
|
|
Primary Sponsor
|
| Name |
Shruti Zungare |
| Address |
KJ Somaiya College of Physiotherapy Somaiya Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra 400022 |
| Type of Sponsor |
Other [SELF ] |
|
|
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 |
| Dr Shruti Zungare |
KJ Somaiya College of Physiotherapy |
Adult neuro department
Mumbai
MAHARASHTRA |
8855990173
shzungare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maharashtra University of Health Sciences (MUHS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Range of motion exercises , balance exercises , gait training with metronome beats |
frequency will be thrice a week for a six weeks protocol |
| Comparator Agent |
Range of motion exercises , sit to stand training , gait training |
frequency will be thrice a week and duration will be for six weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants with chronic stroke willing to participate including all genders in the range of 18-25 on MOCA with brunnstrom motor recovery stage 4 and more and mini-BEST score more than 19 between the age range of 40-59 |
|
| ExclusionCriteria |
| Details |
Participants with any secondary diagnosed condition like dementia Uncorrected visual impairments Uncorrected auditory impairments Uncorrected speech impairments
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
trail making test
stroop color and word test
digit span test
|
18 months
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
21/11/2025 |
| 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="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 aims to investigate whether combining auditory motor synchronization training such as moving in rhythm to music or beats with cognitive-motor dual-task training can more effectively improve cognitive function in individuals with chronic stroke, compared to cognitive-motor dual-task training alone. The research will evaluate attention, memory, and executive functions, which are often affected after stroke. Participants will be randomly assigned to either the combined training group or the control group receiving only cognitive-motor dual-task training, and outcomes will be measured before and after the intervention |