Feasibility Randomised Controlled Trial of Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia
Phase: NA
Conditions: Rehabilitation, Cognition, Stroke, Attention
Sponsor: University of Malaya

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RESEARCH PROTOCOL 
 
1. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
3. 
Research Proposal 
 
TITLE OF RESEARCH PROPOSAL 
Feasibility Randomised Controlled Trial of Intensive Music Therapy on Cognitive Function in 
Subacute Stroke Rehabilitation in Malaysia  
KEY WORDS 
Music therapy; randomised controlled trial; rehabilitation; stroke; cognition; attention 

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BACKGROUND/ JUSTIFICATION 
 
Stroke is a leading cause of long-term disability worldwide, often resulting in cognitive 
impairments, particularly in memory, attention, and executive function, which significantly impact 
patients' quality of life and daily functioning. Research indicates that music therapy can enhance 
cognitive recovery during neurorehabilitation by engaging multiple brain networks and promoting 
neuroplasticity. There is still limited evidence on the specific effects of intensive music therapy 
during the subacute phase, a critical period for neurorehabilitation. In addition, there is no 
published report on the efficacy of structured music therapy as part of a cognitive rehabilitation 
program in Malaysia, despite a concerted move to promote the use of music for therapeutic 
purposes in this country over the last decade. Music therapy has not been a part of a formal 
therapeutic modality in most neurorehabilitation program locally, unlike the more established 
music therapy practice in neighbouring countries such as Singapore. This study proposes to 
investigate the effects of intensive music therapy on cognitive functions in subacute stroke 
patients, while also assessing its feasibility within regular rehabilitation program in Malaysian 
setting. If successful, this approach could support the integration of music therapy into clinical 
neurorehabilitation settings, promoting its wider use for cognitive recovery post-stroke. 
 
OBJECTIVES/OUTCOMES 
 
Objectives:  
1. To assess the feasibility of recruiting, retaining, and ensuring adherence of subacute stroke 
patients to an intensive music therapy program within a neurorehabilitation setting. 
2. To evaluate the practicality of integrating music therapy into existing stroke rehabilitation 
protocols, including the training requirements for staff, resource availability, and logistical 
considerations. 
3. To gather preliminary data on the impact of intensive music therapy on cognitive function, 
specifically memory, attention, and executive function, to estimate effect sizes and inform 
the design of a larger, fully powered randomized controlled trial. 
 
Expected outcomes: 
 
1. The study successfully recruits and retains the target number of subacute stroke patients, 
with a high adherence rate to the intensive music therapy sessions. 
2. The intervention is effectively integrated into the existing stroke rehabilitation program, with 
staff adequately trained and resources efficiently utilized. 
3. Preliminary data show trends of improvement in cognitive functions (e.g., memory, attention, 
executive function) among patients receiving music therapy 
 
METHODOLOGY 
 
Study design 
 
This study will be a feasibility randomised controlled trial (RCT) in one centre, with two parallel 
groups: an intervention group receiving intensive music therapy in addition to standard 
neurorehabilitation, and a control group receiving only standard neurorehabilitation. A certified 
music therapist will conduct the intervention and a trained assessor will evaluate the outcome. 
The assessor is blinded to the patients’ allocation group and will evaluate the cognitive outcomes 
at baseline, at two weeks (after 8 sessions) and at 1 month post intervention. All patients who 

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are admitted to the rehabilitation ward for stroke rehabilitation will be screened and approached. 
Informed consent will be obtained from eligible patients before randomisation.  
 
To ensure that there are exactly 15 patients in both the control and intervention groups, block 
randomization will be used using a random number generator. After randomization, the group 
assignments will be kept in a password-protected file that only the study coordinator can access. 
The assessor will not have access to this information because the patients will be labelled with 
anonymous codes that do not reveal whether they are in the control or intervention group. The 
assessor will only know the code, not the group assignment, ensuring unbiased evaluation. 
 
Intervention group  
The music therapy session described follows a structured and engaging approach, aimed at 
enhancing the patient's cognitive skills during neurorehabilitation. Here’s a summary of the 
session components: 
 
1. Relaxation Phase: The session begins with a five-minute deep breathing exercise to help the 
participant relax and prepare mentally for the activity. 
 
2. Song Selection: The therapist presents a list of 50 well-known pop songs from the past three 
decades, available in four languages (Malay, English, Mandarin, and Tamil). The participant 
chooses a song based on personal preference, promoting cultural relevance and personal 
connection. 
 
3. Instrument Selection and Familiarization: The therapist offers five percussion instruments 
(kompang, djembe, tambourine, maracas, shaker) for the participant to explore. The participant 
selects one instrument to accompany the chosen song. 
 
4. Rhythmic Training: The participant learns to play a rhythmic pattern that complements the 
song. Once mastered, they sing along with the therapist while playing the rhythm. 
 
5. Progression and Adjustment: If the participant successfully plays the rhythm for over 50% of 
the song duration, they are invited to choose another song and instrument. If struggling, they are 
prompted to select another song to prevent frustration. Rest breaks are included, and the 
therapist adjusts the session based on the participant’s endurance. 
 
6. Session Frequency: Each session lasts 45 minutes and is conducted four times a week for 
two weeks, integrated with the patient’s standard neurorehabilitation. 
 
7. Customization: The therapist tailors the sessions according to the patient’s preferences, 
medical condition, and emotional state, with real-time adjustments based on feedback and 
continuous coordination with the rehabilitation team. 
 
This individualized approach aims to enhance patient engagement and recovery by integrating 
music, rhythm, and therapeutic interaction into the neurorehabilitation process. 
 
Control group 
In the control group, participants will receive the standard neurorehabilitation program prescribed 
by the rehabilitation team, without the addition of music therapy. 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. The key components typically include: 
 
1. Attention Training: Exercises that improve sustained, selective, and divided attention, crucial 
for regaining concentration in daily activities. 

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2. Memory Aids: Tools like mnemonic strategies, repetition tasks, and external memory aids 
(e.g., calendars, notes) help rebuild short-term and working memory. 
3. Executive Function Training: Targeting skills such as problem-solving, planning, and 
organizing tasks through structured exercises, gradually improving independent thinking. 
4. Communication and Language Therapy: Speech-language pathologists work with patients to 
improve verbal and non-verbal communication, focusing on both comprehension and expression. 
5. Problem-Solving Exercises: These help patients break down real-life problems into smaller, 
manageable steps, encouraging better decision-making skills. 
 
The control group’s daily rehabilitation sessions will last for 45 minutes, mirroring the music 
therapy group’s session duration, ensuring a fair comparison of outcomes across both groups. 
This comparison will help assess the unique contributions of music therapy on cognitive functions 
like attention, memory, and executive functions in stroke patients. 
 
Inclusion Criteria: 
1. Diagnosed with ischemic or haemorrhagic stroke confirmed by CT scan  
2. Duration of stroke within the first 3 months 
3. Aged 18 - 75 years old  
4. Ability to provide informed consent  
5. Understands Bahasa Melayu or English with basic communication abilities to follow 
instructions during therapy sessions 
6. Mild to moderate cognitive impairments with MoCA score of 10-25.   
 
Exclusion Criteria: 
1. Severe aphasia  
2. Significant uncorrected hearing or visual impairments preventing engagement in music 
therapy. 
3. Severe or unstable medical conditions (e.g., uncontrolled hypertension or diabetes). 
4. Medications that significantly impair cognition or motor function (e.g., high-dose sedatives). 
5. History of neurological diseases other than stroke (eg, Parkinson’s disease). 
 
Outcome measures  
This will be assessed at baseline, after completion of 8 sessions and also at 1 month after 
completion.  Primary outcome measures are Montreal Cognitive Assessment (MoCA), Trail 
Making Test (TMT), Digit Span (Forward and Backward) and Clock Drawing Test (CDT). The 
secondary outcome measure is MBI.  
 
Sample size calculation:  
 
A sample of 30 subacute stroke patients (15 control and 15 intervention) will be recruited from 
the UMMC rehabilitation ward. This number is chosen based on practical considerations to 
evaluate feasibility metrics and exploratory analysis as in the objectives. For these purposes, a 
sample size of 30 is typically adequate to gather enough information about the practical aspects 
of the trial. This number could also ensure that the feasibility objectives are met even with at 
least 20% dropouts. The average stroke admission to the rehabilitation ward in UMMC is five 
patients per week, and the number of potential patients that will be eligible is estimated about 2 
per week. This total number of 30 will be sufficient within the study period and the grant duration.  
 
Statistical Analysis:  
 
Descriptive Statistics and Exploratory Inferential Statistics will be used in this study. 
 
The means, standard deviations, and 95% confidence intervals (CIs) for cognitive outcome 
measures (e.g., memory, attention, executive function scores) at baseline, post-intervention, and 

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follow-up will be used. This will provide a preliminary understanding of the data distribution and 
effect sizes. 
 
For the exploratory Inferential Statistics, independent t-test (or Mann-Whitney U Test) will be 
used to compare the mean changes in cognitive scores between the intervention and control 
groups. The independent t-test if the data are normally distributed. If not, we will use the Mann-
Whitney U test as a non-parametric alternative. 
 
Within each group, we will compare the baseline and post-intervention scores using the paired 
t-test for normally distributed data or the Wilcoxon signed-rank test for non-parametric data. 
Cohen’s d will be used for independent t-tests (between groups) or r for non-parametric tests.  
 
A repeated measures ANOVA (if the data is normally distributed) or a mixed-effects model will 
be used to explore changes over time (baseline, post-intervention, and follow-up). Given the 
small sample size, these analyses will likely be underpowered but can provide estimates of 
variability and preliminary trends. 
 
 
RESEARCH DATA 
 
Where will the data be kept?  
The demographic data of the patients, especially the control group will be kept in the EMR as 
the usual practise, since they receive neurorehabilitation therapy as a standard care. The 
additional baseline data for the study, data on cognitive performance and other relevant data 
will be kept in a separate research file. The files are in the laptop will be secured with password 
and the notes will be kept in a locker in the Department of Rehabilitation Medicine, Faculty of 
Medicine with one of the co-researchers.  
 
Anonymity of data 
All patients will be identified with a code number and not real names in the research files. The 
data entry into the excel sheet and into the research thumb drive will follow the similar process.  
 
Who will have access to the research data? 
All the co-researchers & research assistant  
 
How long will the data be kept?   
7 years 
 
BUDGET / FINANCIAL SUPPORT (IF APPLICABLE):  
 
Grant: Yayasan Penyelidikan Otak, Minda Dan Neurosains Malaysia of RM6,000 
 
 
GANTT CHART  
 
 
Dec – 
Feb 
2024/25 
March –
June 
2025 
July – 
Aug 
2025 
Sept – 
Feb  
2025/26 
March 
–June 
2026 
July –
Oct 
2026 
1. Development of the 
project and trial 
registry 
 
 
 
 
 
 

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2. Recruitment and 
randomisation phase  
 
 
 
 
 
 
3. Data entry & analysis 
 
 
 
 
 
 
4. Manuscript writing 
 
 
 
 
 
 
5. Submission for 
publication  
 
 
 
 
 
 
6. Promote research 
outcomes 
 
 
 
 
 
 
 
REFERENCES (up to 10 references) 
 
1. Thaut, M. H., Gardiner, J. C., Holmberg, D., Horwitz, J., Kent, L., Andrews, G., Donelan, B., & 
McIntosh, G. R. (2009). Neurologic Music Therapy improves executive function and emotional 
adjustment in traumatic brain injury rehabilitation. Annals of New York Academy Sciences, 1169, 406-
416. 
2. Thaut, M. H. (2010). Neurologic Music Therapy in cognitive rehabilitation. Music Perception, 27(4), 
281-285. 
3. Yoo, G. E., & Kim, S. J. (2016). Rhythmic auditory cueing in motor rehabilitation for stroke patients: 
Systematic review and meta-analysis. Journal of Music Therapy, 53(2), 149-177 
4. Alluri, V., Toiviainen, P., Jääskeläinen, I. P., Glerean, E., Sams, M., & Brattico, E. (2012). Large-scale 
brain networks emerge from dynamic processing of musical timbre, key and rhythm. NeuroImage, 
59(4), 3677-3689. 
5. Antić, S., Morović, S., Kes, V. B., Zavoreo, I., Jurašić, M. J., & Demarin, V. (2012). Enhancement of 
stroke recovery by music. Periodicum Biologorum, 114(3), 397-401. 
6. Cha, Y., Kim, Y., & Chung, Y. (2014). Immediate effects of rhythmic auditory stimulation with tempo 
changes on gait in stroke patients. Journal of Physical Therapy Science, 26(4), 479-482.  
7. Fang, R., Ye, S., Huangfu, J., & Calimag, D. P. (2017). Music therapy is a potential intervention for 
cognition of Alzheimer’s Disease: A mini-review. Translational Neurodegeneration, 6(2), 1-8. 
8. Jeong, E. (2013). Psychometric validation of a music-based attention assessment: Revised for 
patients with traumatic brain injury. Journal of Music Therapy, 50(2), 66-92. 
9. Magee, W. L., Clark, I. N., Tamplin, J., & Bradt, J. (2017). Music interventions for acquired brain injury: 
Reviews. 
Cochrane 
Database 
of 
Systematic 
Reviews, 
2017(1), 
1-130, 
doi: 
10.1002/14651858.CD006787.pub3. 
10. Stegemöller, E. L. (2014). Exploring a neuroplasticity model of music therapy. Journal of Music 
Therapy, 51(3), 211-227. 
 
POTENTIAL IMPACT 
 
This study could provide evidence supporting the integration of music therapy into 
neurorehabilitation programs for cognitive recovery post-stroke. If proven feasible and effective, 
it may set a precedent for similar programs globally, contributing to the development of more 
comprehensive, multidisciplinary rehabilitation approaches. As a feasibility RCT, this study would 
lay the groundwork for larger, fully powered trials. It can provide essential data on recruitment, 
retention, adherence, and preliminary effect sizes, informing the design of larger studies that 
could further validate the effectiveness of music therapy. This study could lead to the 
development of a structured music therapy programs in Malaysia’s public and private healthcare 
sectors, offering a novel, culturally engaging, and accessible form of rehabilitation to enhance 
cognitive recovery for stroke patients locally.  
 
 
 
 
 

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