- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06323330
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be done in two stages:
- Stage 1 (Intervention formulation): A battery for therapy will be formulated with the help of SLT in conjunction with the expert(s) in Indian music, neurologist, and physiologist. In a series of physical and online meetings, the duration, frequency, and content of the therapy programme will be formulated. The stage(s) at which NIRS will be conducted will also be decided. This will not involve any patient recruitment and should be finished in three months.
- Stage 2 (Feasibility phase): The feasibility run will be done in 10 eligible patients. With further adaptations depending upon the experience in the feasibility phase, the pilot phase will be conducted, in which the treatment arms will be randomized.
Stage 2 (Pilot phase): Assuming standard error of measurement for participants with aphasia as 4.33 points with a 5-point difference considered clinically meaningful for the Western Aphasia Battery (WAB), and considering that no such prior study is there, 30 patients in intervention and control arm would be initially taken. Therefore, the total sample size 10+30+30=70 patients.
- The randomization will be done in 1:1 ratio, via a computer-generated random number sequence which will be in a sealed opaque envelope. The allocation will be concealed, and the treatment arm will be revealed after the patient has been screened and has consented for the study.
- The outcome assessment will be by a blinded assessor, who will be a co-investigator in the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deepti Vibha
- Phone Number: +91-9868398263
- Email: deeptivibha@aiims.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All of the following
- Age ≥18 years of age
- Stroke with non-fluent aphasia, within one year of ictus
- Imaging evidence suggestive of ischemic or hemorrhagic stroke of dominant hemisphere
- Patient is alert and able to follow simple commands (should not have global aphasia)
- Motivated caregiver
- Informed and signed consent
Exclusion Criteria:
Any of the following:
- Patients with a history of a previous stroke other than the index event, which can explain the aphasia.
- 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)
- Patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
- Use of psychotropic drugs that interfere with patient evaluation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The intervention arm will be given the Music Therapy, the Indian language adapted module
|
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
|
Active Comparator: Active comparator
The active comparator arm will be given the standard speech rehabilitation.
|
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Western Aphasia Battery Score
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Western Aphasia Battery Score
Time Frame: 6 weeks
|
6 weeks
|
functional Near Red Spectroscopy measures
Time Frame: 12 weeks
|
12 weeks
|
modified Rankin Score
Time Frame: 12 weeks
|
12 weeks
|
Fugl Meyer Assessment Scores
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-1623
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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