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| Name | Class |
|---|---|
| Institute of Human Behavior and Allied Sciences | UNKNOWN |
| Indian Institute of Technology, New Delhi | UNKNOWN |
| Vardhman Mahavir Medical College And Safdarjung Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention arm will be given the Music Therapy, the Indian language adapted module |
|
| Active comparator | Active Comparator | The active comparator arm will be given the standard speech rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speech rehabilitation | Other | Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Aphasia Battery Score | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Western Aphasia Battery Score | 4 weeks | |
| functional Near Red Spectroscopy measures | 8 weeks | |
| modified Rankin Score |
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Inclusion Criteria:
All of the following
Exclusion Criteria:
Any of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deepti Vibha | Contact | +91-9868398263 | deeptivibha@aiims.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences, New Delhi | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
IPD will be shared upon request to the PI
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| ID | Term |
|---|---|
| D001039 | Aphasia, Broca |
| ID | Term |
|---|---|
| D001037 | Aphasia |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
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| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia
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The outcome assessor will be blinded to the intervention
| 8 weeks |
| Fugl Meyer Assessment Scores | 8 weeks |
| Safdarjung Hospital | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
|
| Institute of Human Behavior and Allied Sciences | Recruiting | Delhi | 110029 | India |
|
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |