Music Therapy After Stroke (Subacute Phase): Assessing the Impact of Motivation and Neuroplasticity on Recovery of Upper-limb Impairment and Attention Deficits
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Motivation: Brain Injury Rehabilitation Trust Motivation Questionnaire (BMQ-S) [self-reported]
研究概览
简要总结
The goal of this longitudinal, single-subject study is to investigate the role of motivation in music therapy for stroke patients within the subacute phase, who experience upper limb and/or attention deficits. The main questions it aims to answer are:
- Does music therapy increase patient's motivation to rehabilitate?
- Do increases in motivation correlate with functional improvements, in particular upper limb and/or attention skills?
Participants will receive up to 9 music therapy sessions within 3-5 weeks, with functional assessments before and after each period. Each participant serves as their own comparison: researchers will compare a period with standard care only (control phase) to a period with music therapy plus standard care (intervention phase), the order of which will be randomized in advance.
详细描述
Rationale: Stroke is a highly disabling condition, for which music therapy is regularly used in rehabilitation. Motivation is considered to be a mechanism for functional improvements, including in neurologic music therapy (NMT), likely due to potential mood improvements, but it is not generally explicitly investigated. This motivation level may in turn affect not only functional outcomes and subjective well-being, but also adherence to other rehabilitation therapies.
Objectives: The primary goal of the study is to investigate motivation as an underlying mechanism of neurologic music therapy (NMT) for stroke patients experiencing upper-limb impairments and/or cognitive deficits, in the sub-acute phase of stroke. A secondary goal is to assess NMT-related changes in motor function, cognitive outcomes, and self-reported measures of well-being.
The hypothesis is that NMT will increase motivation, and that increased motivational state will positively affect functioning in both motor and/or cognitive domains.
Study design: The study has a longitudinal, single-subject design; as stroke patients are not a homogenous group, this design is adopted to control for expected within-subject variations. To account for variability in brain damage that is caused by stroke, each subject thus serves as their own control, and a longitudinal, repeated-measures design is selected. Participants will be randomized into two groups for a cross-over design, either receiving the intervention or the control phase first or vice versa, which counters order effects and assesses intervention effectiveness (as part of the secondary goals).
All subjects will receive NMT targeting both upper- limb movement and attention. All participants will receive a target of 9 NMT sessions (participants who complete a minimum of 6 sessions will be included in the analysis) over 3-6 weeks (depending on the rehabilitation trajectory, as subacute patients generally are admitted for a minimum of ± 6 and a maximum of 16 weeks), aiming for an average of 3 sessions per week, but adjusted to a patient's expected length of stay and ability, using a tailored approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Analyses will be done after blinding to participant id and gender.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects had their first-ever supratentorial stroke between 2 weeks and up to 6 months before enrolment
- •Paretic upper limb and/or attention/ concentration problems
- •Ability to communicate in Dutch or English
排除标准
- •Severe (global) aphasia
- •paralysis of upper limb
- •severe cognitive decline (MMSE <24)
研究组 & 干预措施
Music Therapy + Care as Usual
9 music therapy sessions within 2-5 weeks during stroke rehabilitation, in addition to care as usual.
干预措施: Neurologic Music Therapy (Behavioral)
Care as Usual
2-5 weeks of care as usual, without music therapy
结局指标
主要结局
Motivation: Brain Injury Rehabilitation Trust Motivation Questionnaire (BMQ-S) [self-reported]
时间窗: This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).
The BMQ-S is a 34-item questionnaire, which measures the motivation levels of the stroke survivor, using a 4-point likert scale (always, often, sometimes, never). Items that involve different factors such as anhedonia, perseveration, poor initiation, or distractibility, are summed to create a total score from 34 to 136, with higher scores representing greater difficulties in motivation.
次要结局
- Motor Function: Barthel Index (BI)(This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).)
- Cognition: Cancellation Wechsler Adult Intelligence Scale (WAIS-IV)(This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).)
- Cognition: Verbal Fluency Test(This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).)
- Cognition: Trail Making Test (TMT)(This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).)
- Cognition: Color-Word Interference Test, also known as Stroop test(This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).)
- Cognition: WAIS IV Digit Span Test - Forward and Backward(This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).)
- Motor Function: Action Research Arm Test (ARAT)(This outcome measure will be administered at 3 different time points (TP): Baseline/TP1 (week1), Mid-Trial/TP2 (week 4) and Final Measures/TP3 (week 7).)
研究者
Rebecca Schaefer
Associate professor
Universiteit Leiden
