Clinical trial NCT06763003: Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia
Official title: Feasibility Randomised Controlled Trial of Intensive Music Therapy on Cognitive Function in Subacute Stroke Rehabilitation in Malaysia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation
Cognition
Stroke
Attention
Keywords: Music therapy
randomised controlled trial
rehabilitation
stroke
cognition
attention
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.
measure: Trail Making Test (TMT)
timeFrame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.
measure: Digit Span (Forward and Backward)
timeFrame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.
measure: Clock Drawing Test (CDT)
timeFrame: This will be assessed at baseline, after completion of 8 sessions, an average of 2 weeks and also at 1 month after completion.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Thaut, M. H. (2010). Neurologic Music Therapy in cognitive rehabilitation. Music Perception, 27(4), 281-285.
citation: 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.