Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Speech rehabilitation.
- Who it may be relevant to
- Registry conditions: Stroke Rehabilitation, Aphasia, Broca. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question\[s\] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms.
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.
Interventions
- Other Speech rehabilitation
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
Primary outcome measures
- Western Aphasia Battery Score [Time frame: 8 weeks]
Secondary outcome measures (4)
- Western Aphasia Battery Score [Time frame: 4 weeks]
- functional Near Red Spectroscopy measures [Time frame: 8 weeks]
- modified Rankin Score [Time frame: 8 weeks]
- Fugl Meyer Assessment Scores [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
India · 3 centers
- All India Institute of Medical Sciences, New Delhi — New Delhi
- Safdarjung Hospital — New Delhi
- Institute of Human Behavior and Allied Sciences — Delhi
Identifiers
NCT: NCT06323330 · I-1623