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

Not Applicable

Not yet recruiting

• Conditions: Rehabilitation; Cognition; Stroke; Attention

• Registration Number: NCT06763003
• Lead Sponsor: University of Malaya

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Start: 2025-02-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	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
Trail Making Test (TMT)	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.
Digit Span (Forward and Backward)	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
Clock Drawing Test (CDT)	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