NCT07522463

Brief Summary

Stroke often leads to significant cognitive impairment, impacting quality of life. While existing rehabilitation options exist, there's a need for innovative, accessible, and patient-centered solutions. Research suggests music can engage multiple brain networks associated with sensory and motor processes, cognition, and affective regulation, potentially enhancing cognitive functions like attention and processing speed as well. Home-based interventions have also demonstrated positive impacts on rehabilitation adherence and outcomes. Building on this foundation, this study proposes to develop and pilot test a home-based musical rehabilitation program to improve attention and processing speed in Malaysian stroke survivors.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 27, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

AttentionProcessing SpeedHome-based Music Rehabilitation ProgramStrokeMalaysia

Outcome Measures

Primary Outcomes (4)

  • Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening tool designed to detect mild cognitive impairment. It demonstrates higher sensitivity in identifying subtle cognitive deficits compared to other screening instruments. Scale Range: 0 to 30 Interpretation: Higher scores indicate better cognitive function Cut-off Score: A score of 26 and above is generally considered normal cognitive function

    4 months

  • Trail Making Test (TMT A and B)

    Trail Making Tests are tests of speed for attention, sequencing, mental flexibility, visual search, and motor function.

    4 months

  • Digit Span (Forward and Backward)

    Forward Digit Span (FDS) assesses short-term, auditory memory, while Backward Digit Span (BDS) tests working memory and central executive processing.

    4 months

  • Clock Drawing Test (CDT)

    The Clock Drawing Test (CDT) is a quick,, widely used neurocognitive screening tool designed to detect dementia, Alzheimer's, and other cognitive impairments.

    4 months

Secondary Outcomes (1)

  • Cogniplus software for Reaction Time and Attention tests

    4 months

Study Arms (2)

Experimental: Home-Based Music Therapy Rehabilitation Program

EXPERIMENTAL

1. Song Materials and Levels The song materials selected for this research will be sourced from copyrighted compositions under UM Centre of Innovation and Enterprise (UMCIE). This maximizes the utilization of readily available resources and serves as a platform for promoting the original works of UM lecturers. The songs are organised into three difficulty levels, with approximately five songs per level. Songs within each level have equivalent rhythmic and cognitive demands, allowing variation without altering task difficulty. 2. Baseline Assessment for Music Therapy Participants will undergo an initial level assessment conducted at the hospital by the trained music therapist. If travel is not feasible, level assessment is conducted at the participant's home. The songs will be presented to the participants and they will choose one song to start.

Other: Musical Home-based Rehabilitation Program

Placebo Comparator: Control group

PLACEBO COMPARATOR

Participants in the control group continue with usual standard neurorehabilitation program as prescribed by the rehabilitation team, without exposure to the music-based intervention. This will provide a baseline to compare outcomes with the intervention group and evaluate the feasibility and preliminary effects of the music therapy intervention. The usual cognitive rehabilitation program during the subacute stroke period focuses on restoring cognitive abilities such as attention, memory, executive functions, and communication.

Other: Control group (standard care)

Interventions

* A certified music therapist will conduct an initial assessment (at the hospital or at your home if travel is not feasible). * You and your caregiver will receive structured training so you can carry out the programme at home independently. * You will complete home sessions of about 40 minutes per session, daily for 5 days per week, for 4 weeks. * Your caregiver will use a simple checklist after each session to record completion, duration, alertness, fatigue, and any concerns. * The therapist will make weekly phone calls to support adherence and address questions. * The therapist will conduct level checks approximately after 2 weeks (at hospital or at home) and may adjust the song tasks to match your progress.

Experimental: Home-Based Music Therapy Rehabilitation Program

* You will continue with the standard neurorehabilitation programme as prescribed by your rehabilitation team. * You will not take part in the home-based music therapy programme.

Placebo Comparator: Control group

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with ischemic or haemorrhagic stroke confirmed by CT scan
  • to 70 years old
  • Duration of stroke within the first one year
  • Ability to provide informed consent
  • Understands Bahasa Melayu or English with basic communication abilities to follow instructions during therapy sessions
  • Mild to moderate cognitive impairments with MoCA score of 10-25, with incomplete score for the attention sections
  • Availability of caregiver (formal or informal) who can assist in the music therapy, monitor and give feedback during the music therapy sessions at home
  • Have one normal functioning hand to perform the movements during the music therapy rehabilitation program
  • Have good balance and able to sit upright

You may not qualify if:

  • Severe aphasia
  • Significant uncorrected hearing or visual impairments preventing engagement in music therapy.
  • Severe or unstable medical conditions (e.g., uncontrolled hypertension or diabetes).
  • Medications that significantly impair cognition or motor function (e.g., high-dose sedatives).
  • History of neurological diseases other than stroke (eg, Parkinson's disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Control GroupsStandard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Wen Fen Beh, PhD

    Universitiy of Malaya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MAZLINA BINTI MAZLAN, MBBS

CONTACT

NIK SHERINA HAIDI BT HANAFI HANAFI, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations