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
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
15mo left

Started Sep 2026

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 Progress7%
Sep 2026Dec 2027

First Submitted

Initial submission to the registry

March 27, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 19, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 27, 2026

Last Update Submit

August 16, 2026

Conditions

Keywords

AttentionProcessing SpeedHome-based Music Rehabilitation ProgramStrokeMalaysia

Outcome Measures

Primary Outcomes (4)

  • Test of Everyday Attention

    Test of Everyday Attention (TEA) is designed for adults aged 18 to 80 years. Rather than a single global scale, it evaluates distinct attentional systems through eight separate subtests, yielding individual raw scores, percentiles, and scaled scores converted via age-normed data.

    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

  • Stroop Test

    The Stroop test assesses a person's ability to inhibit cognitive interference, measure selective attention, and evaluate processing speed. It requires participants to name the ink color of a written word while ignoring the word's actual meaning (such as naming "blue" when the word "red" is printed in blue ink)

    4 months

Study Arms (2)

Experimental: Home-Based Music-based Intervention Rehabilitation Program

EXPERIMENTAL

The intervention session will last approximately 40 minutes and will comprise: (1) attentional priming for 3-5 minutes; (2) rhythm-action training for approximately 30 minutes; and (3) a brief rest, feedback and session-recording period for approximately 5 minutes. Participants will be prescribed five sessions per week for four consecutive weeks, giving a total of 20 sessions. This dosage is consistent with stroke rehabilitation recommendations promoting intensive, repetitive practice and with intervention durations used in previous music therapy studies and protocols after stroke.

Other: Musical Home-based Rehabilitation Program

Placebo Comparator: Control group

PLACEBO COMPARATOR

Participants in the control and intervention groups will continue to receive the usual multidisciplinary stroke rehabilitation programme as prescribed by their treating rehabilitation team at the Department of Rehabilitation Medicine, UMMC. The intervention group will receive the home-based music rehabilitation programme in addition to usual rehabilitation, whereas the control group will receive usual rehabilitation alone. At UMMC, outpatient rehabilitation is typically delivered approximately twice weekly, with sessions lasting about 45 minutes, although frequency and content are individualised according to clinical need. Usual cognitive rehabilitation may include attention, memory and executive function training, communication and language therapy, and functional cognitive activities.

Other: Control group (standard care)

Interventions

The intervention session will last approximately 40 minutes, comprising: (1) 3-5 minutes of attentional priming; (2) approximately 30 minutes of rhythm-action training; and (3) approximately 5 minutes for rest, feedback and session recording. Participants will complete five sessions per week for four consecutive weeks (20 sessions), consistent with recommendations for intensive, repetitive stroke rehabilitation and previous music-based intervention protocols.⁴¹-⁴³ During rhythm-action training, participants will strike corresponding desk bells in response to visual notation and auditory cues at 60 or 90 beats per minute. Responses will be classified as correct when the appropriate bell is struck within the designated beat interval; errors include incorrect, omitted, additional or mistimed strikes. Task difficulty will be reviewed weekly and adjusted by varying tempo, rhythmic complexity, number of tones or cueing. Participants will progress after achieving ≥80% accuracy across two cons

Experimental: Home-Based Music-based Intervention Rehabilitation Program

Participants in both groups will continue usual multidisciplinary stroke rehabilitation at the Department of Rehabilitation Medicine, UMMC. The intervention group will receive the home-based music rehabilitation programme in addition to usual care, while the control group will receive usual care alone. Outpatient rehabilitation is typically provided twice weekly for approximately 45 minutes per session, with frequency and content individualised according to clinical needs. Cognitive rehabilitation may include attention and memory training, executive function exercises, communication and language therapy, and functional cognitive activities integrated into daily living. Therapy type, frequency and duration will be documented throughout the study.

Placebo Comparator: Control group

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \< 75 years
  • First-episode stroke within the last 12 months
  • Montreal Cognitive Assessment (MoCA) of 15- 25, with impairment defined as failure to achieve the prespecified minimum score on the attention-related MoCA items.
  • Sufficient cognitive ability to follow multi-step instructions
  • Functional use of at least one upper limb to perform musical/rhythmic movements
  • Medically stable with the ability to maintain an upright sitting position with good balance

You may not qualify if:

  • Uncontrolled psychiatric or behavioural disorders that may interfere with participation
  • Uncontrolled seizures or epilepsy
  • Significant aphasia or hemispatial neglect
  • Severe visual or visual field deficits

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

September 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations