Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation

NCT06323330 | Recruiting DMC

• 1 other identifier: I-1623
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stroke Rehabilitation; Aphasia, Broca

Keywords

Post stroke non-fluent aphasia; Melodic Intonation Therapy; Indian Adaptation

Outcome Measures

Primary Outcomes (1)

• Western Aphasia Battery Score

  8 weeks

Secondary Outcomes (4)

• Western Aphasia Battery Score

  4 weeks

• functional Near Red Spectroscopy measures

  8 weeks

• modified Rankin Score

  8 weeks

• Fugl Meyer Assessment Scores

  8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will be given the Music Therapy, the Indian language adapted module

Other: Speech rehabilitation

Active comparator

ACTIVE COMPARATOR

The active comparator arm will be given the standard speech rehabilitation.

Other: Speech rehabilitation

Interventions

Speech rehabilitation OTHER

Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase

Active comparator; Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Institute of Human Behavior and Allied Sciences: collaborator
• Indian Institute of Technology, New Delhi: collaborator
• Vardhman Mahavir Medical College And Safdarjung Hospital: collaborator

Study Sites (3)

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Safdarjung Hospital

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Institute of Human Behavior and Allied Sciences

Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Aphasia, Broca

Interventions

Rehabilitation of Speech and Language Disorders

Condition Hierarchy (Ancestors)

Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Deepti Vibha

CONTACT

+91-9868398263; deeptivibha@aiims.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

IN (3)