RehabilitationNCT06763003
Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia
A study testing Music Therapy in people with Rehabilitation and Cognition, run by University of Malaya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rehabilitation, Cognition, Stroke
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility Randomised Controlled Trial of 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.
Read the 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.
- Conditions
- Rehabilitation, Cognition, Stroke, Attention
- Being tested
- Music Therapy, Standard Care (in control arm)
- Keywords
- Music therapy, randomised controlled trial, rehabilitation, stroke, cognition, attention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
is noteworthy for being greater sensitivity than the other test and can detect more mild deficits
Measured: 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.
Measured: 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
Measured: 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
Measured: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Beh Wen Fen, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763003
- Sponsor's protocol ID
- Intensive MT
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: For confidentiality purposes.
Publications
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.
PubMed 28149509Koo 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.
PubMed 19607808Alluri 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.
PubMed 22116038Thaut, M. H. (2010). Neurologic Music Therapy in cognitive rehabilitation. Music Perception, 27(4), 281-285.
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.
PubMed 19673815
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Randomised Controlled Trial of Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia
- ClinicalTrials.gov ID
- NCT06763003
- Acronym / sponsor ID
- Intensive MT
- Conditions
- Rehabilitation, Cognition, Stroke, Attention
- Keywords
- Music therapy, randomised controlled trial, rehabilitation, stroke, cognition, attention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care group | Active comparator | Other: Standard Care (in control arm)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. |
| Music Therapy Group | Experimental | Other: Music TherapyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyThe 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 Group |
| Standard Care (in control arm)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 group |
Primary outcome
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
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Results publication: PubMed 28149509Fang 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.
- Results publication: PubMed 19607808Koo 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.
- Results publication: PubMed 22116038Alluri 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.
- Results publicationThaut, M. H. (2010). Neurologic Music Therapy in cognitive rehabilitation. Music Perception, 27(4), 281-285.
- Results publication: PubMed 19673815Thaut 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.
- Individual participant dataSharing planned: Undecided. For confidentiality purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Rehabilitation and Cognition, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAZLINA BINTI MAZLAN PROF, MBBS (+60379675181, mazlinamazlan@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763003, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.