Clinical trial NCT06323330: Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Official title: Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Rehabilitation
Aphasia, Broca
Keywords: Post stroke non-fluent aphasia
Melodic Intonation Therapy
Indian Adaptation
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Institute of Human Behavior and Allied Sciences
name: Indian Institute of Technology, New Delhi
name: Vardhman Mahavir Medical College And Safdarjung Hospital
First posted: 2024-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Aphasia Battery Score
timeFrame: 8 weeks
Secondary outcomes:
measure: Western Aphasia Battery Score
timeFrame: 4 weeks
measure: functional Near Red Spectroscopy measures
timeFrame: 8 weeks
measure: modified Rankin Score
timeFrame: 8 weeks
measure: Fugl Meyer Assessment Scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences, New Delhi
state: Delhi
city: New Delhi
country: India
facility: Safdarjung Hospital
state: Delhi
city: Delhi
country: India
facility: Institute of Human Behavior and Allied Sciences
Study officials:
References: