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

Not Applicable

Recruiting

• Conditions: Stroke Rehabilitation; Aphasia, Broca
• Interventions: Other: Speech rehabilitation

• Registration Number: NCT06323330
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

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 Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-21
• Study Start: 2024-06-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-10-31
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All of the following

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

Any of the following:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Speech rehabilitation	The intervention arm will be given the Music Therapy, the Indian language adapted module
Active comparator	Speech rehabilitation	The active comparator arm will be given the standard speech rehabilitation.

Primary Outcome Measures

Name	Time	Method
Western Aphasia Battery Score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Western Aphasia Battery Score	4 weeks
functional Near Red Spectroscopy measures	8 weeks
modified Rankin Score	8 weeks
Fugl Meyer Assessment Scores	8 weeks

Trial Locations

Locations (3)

All India Institute of Medical Sciences, New Delhi; 🇮🇳 New Delhi, Delhi, India

Safdarjung Hospital; 🇮🇳 New Delhi, Delhi, India

Institute of Human Behavior and Allied Sciences; 🇮🇳 Delhi, India