Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
NCT ID: NCT06323330
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-06-01
2026-11-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
The intervention arm will be given the Music Therapy, the Indian language adapted module
Speech rehabilitation
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
Active comparator
The active comparator arm will be given the standard speech rehabilitation.
Speech rehabilitation
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
Interventions
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Speech rehabilitation
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years of age
2. Stroke with non-fluent aphasia, within one year of ictus
3. Imaging evidence suggestive of ischemic or hemorrhagic stroke of dominant hemisphere
4. Patient is alert and able to follow simple commands (should not have global aphasia)
5. Motivated caregiver
6. Informed and signed consent
Exclusion Criteria
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
18 Years
99 Years
ALL
No
Sponsors
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Institute of Human Behavior and Allied Sciences
UNKNOWN
Indian Institute of Technology, New Delhi
UNKNOWN
Vardhman Mahavir Medical College And Safdarjung Hospital
OTHER
All India Institute of Medical Sciences
OTHER
Responsible Party
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Deepti Vibha
Professor
Locations
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All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India
Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, India
Institute of Human Behavior and Allied Sciences
Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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I-1623
Identifier Type: -
Identifier Source: org_study_id