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

NCT06763003 | Not Yet Recruiting

• 1 other identifier: Intensive MT
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rehabilitation; Cognition; Stroke; Attention

Keywords

Music therapy; randomised controlled trial; rehabilitation; stroke; cognition; attention

Outcome Measures

Primary Outcomes (4)

• Montreal Cognitive Assessment (MoCA)

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

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

• Trail Making Test (TMT)

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

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

• Digit Span (Forward and Backward)

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

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

• Clock Drawing Test (CDT)

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

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

Study Arms (2)

Standard Care group

ACTIVE COMPARATOR

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.

Other: Standard Care (in control arm)

Music Therapy Group

EXPERIMENTAL

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.

Other: Music Therapy

Interventions

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.

Music Therapy Group

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.

Standard Care group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (5)

• Fang R, Ye S, Huangfu J, Calimag DP. Music therapy is a potential intervention for cognition of Alzheimer's Disease: a mini-review. Transl Neurodegener. 2017 Jan 25;6:2. doi: 10.1186/s40035-017-0073-9. eCollection 2017.

  PMID: 28149509 RESULT

• Koo SC, Moon BC, Kim JK, Kim CY, Sung SJ, Kim MC, Cho MJ, Cheong YH. OsBWMK1 mediates SA-dependent defense responses by activating the transcription factor OsWRKY33. Biochem Biophys Res Commun. 2009 Sep 18;387(2):365-70. doi: 10.1016/j.bbrc.2009.07.026. Epub 2009 Jul 14.

  PMID: 19607808 RESULT

• Alluri V, Toiviainen P, Jaaskelainen IP, Glerean E, Sams M, Brattico E. Large-scale brain networks emerge from dynamic processing of musical timbre, key and rhythm. Neuroimage. 2012 Feb 15;59(4):3677-89. doi: 10.1016/j.neuroimage.2011.11.019. Epub 2011 Nov 12.

  PMID: 22116038 RESULT

• Thaut, M. H. (2010). Neurologic Music Therapy in cognitive rehabilitation. Music Perception, 27(4), 281-285.

  RESULT

• Thaut MH, Gardiner JC, Holmberg D, Horwitz J, Kent L, Andrews G, Donelan B, McIntosh GR. Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Ann N Y Acad Sci. 2009 Jul;1169:406-16. doi: 10.1111/j.1749-6632.2009.04585.x.

  PMID: 19673815 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Music Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

MAZLINA BINTI MAZLAN PROF, MBBS

CONTACT

+60379675181; mazlinamazlan@um.edu.my

NIK SHERINA HAIDI BT HANAFI PROF, MBBS

CONTACT

+60379492802; niksherina@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant, care provider, investigator and outcome assessor will be evaluated by different disciplines. 1. Participant - ramdomised by principal investigator 2. care provider - music therapist 3. Investigator - rehabilitation specialist 4. outcome assessor - neuropsychologist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 8, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04