- 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
-
-
Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
- Universiti Malaya Medical Centre
-
Contact:
- MAZLINA MAZLAN MAZLAN, MBBS
- Phone Number: +603-79675181
- Email: mazlinamazlan@um.edu.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with ischemic or haemorrhagic stroke confirmed by CT scan
- 18 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
Exclusion Criteria:
- 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).
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 Therapy Rehabilitation Program
|
|
|
Placebo Comparator: Placebo Comparator: Control group
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. |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: 4 months
|
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)
Time Frame: 4 months
|
Trail Making Tests are tests of speed for attention, sequencing, mental flexibility, visual search, and motor function.
|
4 months
|
|
Digit Span (Forward and Backward)
Time Frame: 4 months
|
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)
Time Frame: 4 months
|
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 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
|
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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