Stroke RehabilitationNCT06323330
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
A study testing Speech rehabilitation in people with Stroke Rehabilitation and Aphasia, Broca, run by All India Institute of Medical Sciences at 3 sites in India.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke Rehabilitation, Aphasia, Broca
- What is being tested?
- Speech rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesIndia
- Study dates
- 1 Jun 2024to 30 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
Institute of Human Behavior and Allied Sciences
Delhi, National Capital Territory of Delhi, 110029
Deepti Vibha, 09868398263, deeptivibha@gmail.com
- Recruiting
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, 110029
Deepti Vibha, 09868398263, deeptivibha@gmail.com
- Recruiting
Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, 110029
Deepti Vibha, 09868398263, deeptivibha@gmail.com
About this study
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.
Read the 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.
- Conditions
- Stroke Rehabilitation, Aphasia, Broca
- Being tested
- Speech rehabilitation
- Keywords
- Post stroke non-fluent aphasia, Melodic Intonation Therapy, Indian Adaptation
- Medical subject headings
- Aphasia, Broca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech rehabilitationOther
Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will be given the Music Therapy, the Indian language adapted module Receives: Other: Speech rehabilitation |
| Active comparator | Active comparator | The active comparator arm will be given the standard speech rehabilitation. Receives: Other: Speech rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Aphasia Battery Score
Measured: 8 weeks
Secondary outcomes (4)
Western Aphasia Battery Score
Measured: 4 weeks
functional Near Red Spectroscopy measures
Measured: 8 weeks
modified Rankin Score
Measured: 8 weeks
Fugl Meyer Assessment Scores
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jun 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Human Behavior and Allied Sciences, Indian Institute of Technology, New Delhi, Vardhman Mahavir Medical College And Safdarjung Hospital
- Responsible party
- Principal investigator, Deepti Vibha, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323330
- Sponsor's protocol ID
- I-1623
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon request to the PI