- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522463
Enhancing Attention and Processing Speed Through Home-based Music Rehabilitation Program After Stroke in Malaysia (HMRPAS)
Enhancing Attention and Processing Speed Through Home-based Music Rehabilitation Program After Stroke in Malaysia: A Feasibility Random Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. Using a randomized controlled trial, the program's feasibility and preliminary effectiveness will be evaluated. Participants will undergo cognitive assessments at baseline, post-intervention, and follow-up, complemented by qualitative data collection to understand patient experience.
The anticipated outcomes include a culturally relevant, accessible home-based program tailored for Malaysian stroke survivors, preliminary evidence on the program's impact on attention and processing speed, insights into its feasibility and acceptability, and a foundation for a larger-scale randomized controlled trial. This research has the potential to transform stroke rehabilitation in Malaysia by offering an innovative, patient-centered approach that utilizes music therapy to enhance cognitive recovery and improve quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MAZLINA BINTI MAZLAN, MBBS
- Phone Number: +60379675181
- Email: mazlinamazlan@um.edu.my
Study Contact Backup
- Name: NIK SHERINA HAIDI BT HANAFI HANAFI, MBBS
- Phone Number: +60379492802
- Email: niksherina@um.edu.my
Study Locations
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
- Universiti Malaya Medical Centre
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Contact:
- MAZLINA MAZLAN MAZLAN, MBBS
- Phone Number: +603-79675181
- Email: mazlinamazlan@um.edu.my
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Home-Based Music-based Intervention Rehabilitation Program
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.
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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 |
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Placebo Comparator: Placebo Comparator: Control group
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trail Making Test (TMT A and B)
Time Frame: 4 months
|
Trail Making Tests are tests of speed for attention, sequencing, mental flexibility, visual search, and motor function.
|
4 months
|
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Digit Span (Forward and Backward)
Time Frame: 4 months
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Forward Digit Span (FDS) assesses short-term, auditory memory, while Backward Digit Span (BDS) tests working memory and central executive processing.
|
4 months
|
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Test of Everyday Attention
Time Frame: 4 months
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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.
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4 months
|
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Stroop Test
Time Frame: 4 months
|
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)
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cogniplus software for Reaction Time and Attention tests
Time Frame: 4 months
|
CogniPlus is a computer-based cognitive training and assessment system developed to measure and improve attention, processing speed, and executive functions, particularly in individuals with cognitive impairments following stroke or other neurological conditions. Scale Range: Varies by subtest/module (e.g., attention, processing speed), typically reported as performance scores such as reaction time (milliseconds), accuracy (%), or standardized scores Interpretation: Higher accuracy (%) and standardized scores indicate better cognitive performance Lower reaction time (milliseconds) indicates better processing speed Outcome Metrics: Task-specific measures including reaction time, error rate, and level progression |
4 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wen Fen Beh, PhD, Universitiy of Malaya
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Stroke
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Quality of Health Care
- Quality Indicators, Health Care
- Control Groups
- Standard of Care
Other Study ID Numbers
- Home-based Program
- BKP018-2024-ECRG (Other Identifier: University of Malaya)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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