| CTRI Number |
CTRI/2025/09/094964 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess effectiveness of Rhythmic Auditory Stimulation to improve hand function in Stroke patients |
|
Scientific Title of Study
|
Effectiveness of Rhythmic Auditory Stimulation along with Task-Oriented Exercises on Hand Function and Quality of Life in Stroke Patients-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 |
shubham ajgaonkar |
| Designation |
under graduate intern |
| Affiliation |
RJS college of Physiotherapy,kopargaon |
| Address |
5b 6 krishna chs goregaon east mumbai 400063
sjs hospital near mumbai nagpur highway kopargaon 423601
Mumbai (Suburban)
MAHARASHTRA
400063
India |
| Phone |
8655415139 |
| Fax |
|
| Email |
shubhamajgaonkar1596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shubham ajgaonkar |
| Designation |
under graduate intern |
| Affiliation |
RJS college of Physiotherapy,kopargaon |
| Address |
5b 6 krishna chs goregaon east mumbai 400063
sjs hospital near mumbai nagpur highway kopargaon 423601
Mumbai (Suburban)
MAHARASHTRA
400063
India |
| Phone |
8655415139 |
| Fax |
|
| Email |
shubhamajgaonkar1596@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shubham ajgaonkar |
| Designation |
under graduate intern |
| Affiliation |
RJS college of Physiotherapy,kopargaon |
| Address |
5b 6 krishna chs goregaon east mumbai 400063
sjs hospital near mumbai nagpur highway kopargaon 423601
Mumbai (Suburban)
MAHARASHTRA
400063
India |
| Phone |
8655415139 |
| Fax |
|
| Email |
shubhamajgaonkar1596@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asha Kendra, near Shirdi-Puntamba road, Puntamba- 413707 |
| SJS Hospital, near Mumbai-Nagpur highway, kopargaon-423601 |
|
|
Primary Sponsor
|
| Name |
Shubham Ajgaonkar |
| Address |
5b 6 krishna chs nnp plot no.2 goregaon east mumbai 400063 |
| 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 Tayyaba Munawar PT |
SJS Hospital |
R J S Institute, near Mumbai Nagpur highway Kopargaon, 423601
Ahmadnagar
MAHARASHTRA |
9915182640
---------
munawar.tayyaba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
RHYTHMIC AUDITORY STIMULATION ALONG WITH TASK ORIENTED EXERCISE |
All participants will receive standard physical therapy for 30 minutes, 4 days per week over 3 weeks. Patients in Group A (control group) will undergo only conventional therapy, which includes stretching, strengthening, coordination exercises, functional task training, fine motor activities (e.g., grasping and transferring objects), and sensory integration tasks (e.g., squeezing clay or sponge balls). Patients in Group B (experimental group) will receive Rhythmic Auditory Stimulation (RAS) in addition to functional task practice. RAS will be delivered using rhythmic auditory cues, with each participant’s baseline tempo identified and gradually increased (up to 5% per day) as tolerated. Training will be supervised by a therapist, and tempos will be recorded at baseline and study completion to monitor progress |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Ischemic and haemorrhagic stroke
2. MMSE score above 24
3. Brunnstrom stage 4 to 6
4. Patients with upper limb ROM more than half normal range
5. Patients willing to participate |
|
| ExclusionCriteria |
| Details |
1.presence of previous stroke
2. other neurological conditions
3.visual field defect
4.vestibular disorder
5.hemispatial neglect
6. any other orthopaedic condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.action research arm test
2.wolf motor function test
3.Stroke Specific quality of life scale |
baseline data is assessed 1week before intervention and post data after final week of intervention,only stroke specific quality of life will be assessed 1 month after intervention at end of treatment protocol |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shubhamajgaonkar1596@gmail.com].
- For how long will this data be available start date provided 09-09-2025 and end date provided 26-09-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
ABSTRACT Background:
Stroke is a leading cause of mortality and disability worldwide, with upper limb impairment being a major contributor to decreased independence in activities of daily living (ADLs). Despite partial recovery in 65–85% of stroke survivors, around 20% do not regain functional use of the upper limb. Rhythmic Auditory Stimulation (RAS), a form of neurological music therapy, has shown promise in enhancing motor function post-stroke, particularly for gait. However, limited studies have evaluated its effect on hand function and quality of life. Objective:
To assess the effectiveness of Rhythmic Auditory Stimulation (RAS) combined with task-oriented exercises on improving hand function and quality of life in post-stroke patients, compared to conventional therapy with task-oriented exercises. Methods:
A randomized clinical trial will be conducted on 30 post-stroke patients recruited from the IPD and OPD of Sant Janardhan Swami Hospital, Kopargaon and Asha Kendra, Puntamba. Participants will be randomized into two groups (n=15 each). Group A will receive RAS combined with task-oriented exercises. Group B will receive conventional physiotherapy with task-oriented exercises. Interventions will be provided for 3 weeks (12 sessions), 30 minutes per session.
Outcome measures that will be used: Action Research Arm Test (ARAT) Wolf Motor Function Test (WMFT) Stroke Specific Quality of Life Scale (SS-QOL) Assessments will be conducted at baseline and after the intervention. SS-QOL will also be reassessed at 1-month follow-up. |