| CTRI Number |
CTRI/2025/07/090232 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Speech therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Music therapy in patients with language problems after stroke |
|
Scientific Title of Study
|
Music therapy for rehabilitation in post-stroke non-fluent aphasia: the Indian adaptation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepti Vibha |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 707, Neurosciences Center
Department of Neurology
South West DELHI 110029 India |
| Phone |
911126594485 |
| Fax |
|
| Email |
deeptivibha@aiims.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Deepti Vibha |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 707, Neurosciences Center
Department of Neurology
South West DELHI 110029 India |
| Phone |
911126594485 |
| Fax |
|
| Email |
deeptivibha@aiims.edu |
|
Details of Contact Person Public Query
|
| Name |
Deepti Vibha |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 707, Neurosciences Center
Department of Neurology
South West DELHI 110029 India |
| Phone |
911126594485 |
| Fax |
|
| Email |
deeptivibha@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
ICMR, New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Prof Deepti Vibha |
All India Institute of Medical Sciences, New Delhi |
Department of Neurology, Room number 707, AIIMS, Ansari Nagar, New Delhi, India South West DELHI |
011-26594485
deeptivibha@aiims.edu |
| Prof Suman Kushwaha |
Institute of Human Behavior and Allied Sciences |
HoD Officer, department of neurology, IHBAS, Dilshad Garden, Delhi North DELHI |
01-22114021
sumankushwaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS ethics committee, New Delhi |
Approved |
| IHBAS ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melodic Intonation Therapy |
The Indian Adaptation tool, which will be developed in the feasibility phase, will be tested in the intervention part of the study for a period of 8 weeks |
| Comparator Agent |
Standard Speech Therapy |
The standard therapy which is to be provided to all patients will be provided in the control arm for a period of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Stroke with non-fluent aphasia, within one year of ictus
2. Imaging evidence suggestive of ischemic or hemorrhagic stroke of dominant hemisphere
3. Patient is alert and able to follow simple commands (should not have global aphasia)
4. Motivated caregiver
5. Informed and signed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of a previous stroke other than the index event, which can explain the aphasia.
2. Any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that preclude appropriate follow-up in the study (e.g., distant residence, no family support)
3. Patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
4. Use of psychotropic drugs that interfere with patient evaluation |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the WAB score from baseline, at 4 weeks and at 8 weeks. |
Change in the WAB score from baseline, at 4 weeks and at 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| modified Rankin Scale |
6 and 12 weeks |
| Fugl Meyer Score |
6 and 12 weeks |
| WAB score |
6 weeks |
| functional Near Red Spectroscopy analysis |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="3" 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
|
Stroke remains the second-leading cause of death and the third-leading
cause of death and disability combined. The Global Burden of Disease Study indicates that the lower and
lower-middle-income countries bear the brunt of disability. Aphasia and motor
disability are the most crippling in stroke. Aphasia rehabilitation is often
ignored and underplayed.
In India particularly, aphasia rehabilitation is sub-optimal due to a
combination of lack of trained personnel and suitable adaptive strategies which
are being practiced in the Western world. Music therapy has been shown to
improve verbal fluency. However, there is no adapted and/or
validated tool for the same in Indian patients. Not only the language, but the
musical familiarity of the Indians is also very different from the West. The
Indian ‘raags’, folk songs and popular music should be adapted to the aphasia
rehabilitation program to engage the non-dominant hemisphere for non-fluent
aphasia rehabilitation. The efficacy of this rehabilitation tool can be
established by improvement in aphasia battery performance as well as by near
infrared spectroscopy (NIRS).
We hypothesize that the Indian version of music rehabilitation module
for non-fluent aphasia rehabilitation in post-stroke patients will improve
their scores in Western Aphasia Battery (WAB) and functional near infrared spectroscopy
(fNIRS). We propose to do this by initial formulation of the module by a team of
expert speech and language therapists (SLTs) and neurologists. This will
subsequently be pilot tested and optimized. Finally, a pilot randomized
controlled trial of this intervention will be compared with standard speech
rehabilitation. |