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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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