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RecruitingNCT06323330Updated Oct 13, 2026

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

An interventional study of Speech rehabilitation in Stroke Rehabilitation and Aphasia, Broca, sponsored by All India Institute of Medical Sciences. Recruiting at 3 sites in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by All India Institute of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Updated Oct 13, 2026Study completion movedSponsor changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Stroke Rehabilitation
  • Aphasia, Broca

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Keywords

  • Post stroke non-fluent aphasia
  • Melodic Intonation Therapy
  • Indian Adaptation
03

In context

Aphasia, Broca

35 studies on the registry are indexed under Aphasia, Broca; 11 are open to participants now.

This study's planned enrollment of 60 is above the median of 36 across 33 interventional studies indexed under Aphasia, Broca.

Browse Aphasia, Broca studies →

Lead sponsor

All India Institute of Medical Sciences is the lead sponsor of 27 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intervention

    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

  • OtherSpeech rehabilitation

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

06

What researchers measure

Primary outcomes

  1. Western Aphasia Battery Score

    Time frame: 8 weeks

Secondary outcomes

  1. Western Aphasia Battery Score

    Time frame: 4 weeks

  2. functional Near Red Spectroscopy measures

    Time frame: 8 weeks

  3. modified Rankin Score

    Time frame: 8 weeks

  4. Fugl Meyer Assessment Scores

    Time frame: 8 weeks

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — IPD will be shared upon request to the PI

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Oct 2026, 28 months after the start.

Of 18 interventional studies with no phase under Aphasia, Broca, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 57. This study's planned 28 months is above that.

Completion moved once since we started tracking on Sep 25, 2026: Nov 2026 → Jan 2027, on Oct 13, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2024
First posted
Mar 21, 2024
StartActual
Jun 1, 2024
Primary completionEst.
Oct 31, 2026
CompletionEst.
Jan 30, 2027was Nov 2026
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added, 3 sites removed
Show 3 added (3 India)
  • Institute of Human Behavior and Allied Sciences · Delhi, India
  • All India Institute of Medical Sciences, New Delhi · New Delhi, India
  • Safdarjung Hospital · New Delhi, India
Show 3 removed
  • All India Institute of Medical Sciences, New Delhi · New Delhi, India
  • Safdarjung Hospital · New Delhi, India
  • Institute of Human Behavior and Allied Sciences · Delhi, India
Oct 13, 2026
Study completion
Nov 30, 2026→Jan 30, 2027
Oct 13, 2026
Sponsor
All India Institute of Medical Sciences, New Delhi→All India Institute of Medical Sciences
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    3 sites added, 3 sites removed
    Show 3 added (3 India)
    • Institute of Human Behavior and Allied Sciences · Delhi, India
    • All India Institute of Medical Sciences, New Delhi · New Delhi, India
    • Safdarjung Hospital · New Delhi, India
    Show 3 removed
    • All India Institute of Medical Sciences, New Delhi · New Delhi, India
    • Safdarjung Hospital · New Delhi, India
    • Institute of Human Behavior and Allied Sciences · Delhi, India
    Study completion Nov 30, 2026→Jan 30, 2027
    Sponsor All India Institute of Medical Sciences, New Delhi→All India Institute of Medical Sciences
    + 3 other changes: identifiers, verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06323330
Lead sponsor
All India Institute of Medical Sciences
Collaborators
Institute of Human Behavior and Allied Sciences, Indian Institute of Technology, New Delhi, Vardhman Mahavir Medical College And Safdarjung Hospital
Responsible party
Deepti Vibha (Professor, All India Institute of Medical Sciences) — Principal investigator
First posted
Mar 21, 2024
Start date
Jun 1, 2024
Primary completion
Oct 31, 2026 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Deepti Vibha
Contact
deeptivibha@aiims.edu
+91-9868398263

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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