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

Stroke Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323330
• Other study ID #: I-1623
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: March 2024
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Deepti Vibha
• Phone: +91-9868398263
• Email: deeptivibha[@]aiims.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 30, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Stroke
• Stroke Rehabilitation

Intervention

Other:
• Speech rehabilitation
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi	Indian Institute of Technology, New Delhi, Institute of Human Behavior and Allied Sciences, Vardhman Mahavir Medical College And Safdarjung Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Aphasia Battery Score		12 weeks
Secondary	Western Aphasia Battery Score		6 weeks
Secondary	functional Near Red Spectroscopy measures		12 weeks
Secondary	modified Rankin Score		12 weeks
Secondary	Fugl Meyer Assessment Scores		12 weeks