Enhancing Attention and Processing Speed Through Home-based Music Rehabilitation Program After Stroke in Malaysia: A Feasibility Random Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
Stroke often leads to significant cognitive impairment, impacting quality of life. While existing rehabilitation options exist, there's a need for innovative, accessible, and patient-centered solutions. Research suggests music can engage multiple brain networks associated with sensory and motor processes, cognition, and affective regulation, potentially enhancing cognitive functions like attention and processing speed as well. Home-based interventions have also demonstrated positive impacts on rehabilitation adherence and outcomes. Building on this foundation, this study proposes to develop and pilot test a home-based musical rehabilitation program to improve attention and processing speed in Malaysian stroke survivors.
详细描述
Stroke often leads to significant cognitive impairment, impacting quality of life. While existing rehabilitation options exist, there's a need for innovative, accessible, and patient-centered solutions. Research suggests music can engage multiple brain networks associated with sensory and motor processes, cognition, and affective regulation, potentially enhancing cognitive functions like attention and processing speed as well. Home-based interventions have also demonstrated positive impacts on rehabilitation adherence and outcomes.
Building on this foundation, this study proposes to develop and pilot test a home-based musical rehabilitation program to improve attention and processing speed in Malaysian stroke survivors. Using a randomized controlled trial, the program's feasibility and preliminary effectiveness will be evaluated. Participants will undergo cognitive assessments at baseline, post-intervention, and follow-up, complemented by qualitative data collection to understand patient experience.
The anticipated outcomes include a culturally relevant, accessible home-based program tailored for Malaysian stroke survivors, preliminary evidence on the program's impact on attention and processing speed, insights into its feasibility and acceptability, and a foundation for a larger-scale randomized controlled trial. This research has the potential to transform stroke rehabilitation in Malaysia by offering an innovative, patient-centered approach that utilizes music therapy to enhance cognitive recovery and improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 75 years
- •First-episode stroke within the last 12 months
- •Montreal Cognitive Assessment (MoCA) of 15- 25, with impairment defined as failure to achieve the prespecified minimum score on the attention-related MoCA items.
- •Sufficient cognitive ability to follow multi-step instructions
- •Functional use of at least one upper limb to perform musical/rhythmic movements
- •Medically stable with the ability to maintain an upright sitting position with good balance
排除标准
- •Uncontrolled psychiatric or behavioural disorders that may interfere with participation
- •Uncontrolled seizures or epilepsy
- •Significant aphasia or hemispatial neglect
- •Severe visual or visual field deficits
研究组 & 干预措施
Placebo Comparator: Control group
Participants in the control and intervention groups will continue to receive the usual multidisciplinary stroke rehabilitation programme as prescribed by their treating rehabilitation team at the Department of Rehabilitation Medicine, UMMC. The intervention group will receive the home-based music rehabilitation programme in addition to usual rehabilitation, whereas the control group will receive usual rehabilitation alone.
At UMMC, outpatient rehabilitation is typically delivered approximately twice weekly, with sessions lasting about 45 minutes, although frequency and content are individualised according to clinical need. Usual cognitive rehabilitation may include attention, memory and executive function training, communication and language therapy, and functional cognitive activities.
干预措施: Control group (standard care) (Other)
Experimental: Home-Based Music-based Intervention Rehabilitation Program
The intervention session will last approximately 40 minutes and will comprise: (1) attentional priming for 3-5 minutes; (2) rhythm-action training for approximately 30 minutes; and (3) a brief rest, feedback and session-recording period for approximately 5 minutes. Participants will be prescribed five sessions per week for four consecutive weeks, giving a total of 20 sessions. This dosage is consistent with stroke rehabilitation recommendations promoting intensive, repetitive practice and with intervention durations used in previous music therapy studies and protocols after stroke.
干预措施: Musical Home-based Rehabilitation Program (Other)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: 4 months
The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening tool designed to detect mild cognitive impairment. It demonstrates higher sensitivity in identifying subtle cognitive deficits compared to other screening instruments. Scale Range: 0 to 30 Interpretation: Higher scores indicate better cognitive function Cut-off Score: A score of 26 and above is generally considered normal cognitive function
Trail Making Test (TMT A and B)
时间窗: 4 months
Trail Making Tests are tests of speed for attention, sequencing, mental flexibility, visual search, and motor function.
Digit Span (Forward and Backward)
时间窗: 4 months
Forward Digit Span (FDS) assesses short-term, auditory memory, while Backward Digit Span (BDS) tests working memory and central executive processing.
Clock Drawing Test (CDT)
时间窗: 4 months
The Clock Drawing Test (CDT) is a quick,, widely used neurocognitive screening tool designed to detect dementia, Alzheimer's, and other cognitive impairments.
Test of Everyday Attention
时间窗: 4 months
Test of Everyday Attention (TEA) is designed for adults aged 18 to 80 years. Rather than a single global scale, it evaluates distinct attentional systems through eight separate subtests, yielding individual raw scores, percentiles, and scaled scores converted via age-normed data.
Stroop Test
时间窗: 4 months
The Stroop test assesses a person's ability to inhibit cognitive interference, measure selective attention, and evaluate processing speed. It requires participants to name the ink color of a written word while ignoring the word's actual meaning (such as naming "blue" when the word "red" is printed in blue ink)
次要结局
- Cogniplus software for Reaction Time and Attention tests(4 months)