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NCT Number: NCT06763003

Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia

The purpose of this study is to explore whether intensive music therapy can help improve cognitive functions like memory, attention, and decision-making skills in stroke patients who are undergoing rehabilitation.

This is a feasibility study, meaning it's also designed to see how practical it is to include music therapy as part of stroke rehabilitation. The investigators want to learn how well patients can participate in and stick with this type of therapy, and whether it fits well with other treatments that stroke patients usually receive. By understanding this, the investigators can assess the resources, staff training, and planning needed for music therapy to be part of stroke recovery in the future.

The study will also help the investigators estimate the effects of music therapy, which will be used to design a larger, more detailed study in the future.

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Key information

Conditions

Rehabilitation Attention Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 whoare 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with ischemic or haemorrhagic stroke confirmed by CT scan
  • Duration of stroke within the first 3 months
  • Aged 18 - 75 years old
  • 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.

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).

Treatment and study plan

Music Therapy

Other

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: Relaxation Phase, Song Selection, Instrument Selection and Familiarization, Rhythmic Training, Progression and Adjustment, Session Frequency and Customization. This individualized approach aims to enhance patient engagement and recovery by integrating music, rhythm, and therapeutic interaction into the neurorehabilitation process.

Standard Care (in control arm)

Other

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 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.

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.

    is noteworthy for being greater sensitivity than the other test and can detect more mild deficits

  2. Trail Making Test (TMT)

    Time frame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.

    is easy to understand, and has a short administration which assesses visuoperceptual tracking, processing speed, divided attention, and cognitive flexibility.

  3. Digit Span (Forward and Backward)

    Time frame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.

    is easy to implement, requires minimal training needs, and measures selective attention and cognitive interference

  4. Clock Drawing Test (CDT)

    Time frame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.

    is a screening test for cognitive dysfunction secondary to dementia, delirium, or a range of neurological and psychiatric illnesses

Study contacts

Contact information is provided by the study sponsor or research team.

MAZLINA BINTI MAZLAN PROF, MBBS

CONTACT

[email protected]

+60379675181

NIK SHERINA HAIDI BT HANAFI PROF, MBBS

CONTACT

[email protected]

+60379492802

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Feasibility Randomised Controlled Trial of Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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