Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Action Research Arm Test
研究概览
简要总结
Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. A modified version of the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i) a home-based self-training program using an app for electronic tablets and (ii) weekly group sessions of musical playing strengthening the motivational and emotional components of music playing. A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention.
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
- Single (Outcomes Assessor)
盲法说明
A clinical researcher with expertise in stroke rehabilitation will perform the evaluations and will be blinded to participants' group allocation.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Action Research Arm Test
时间窗: 3 months after completing the intervention
Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.
次要结局
- Change in Sustained Attention to Response Task(3 months after completing the intervention)
- Change in Rey Auditory Verbal Learning Test(3 months after completing the intervention)
- Change in Fluency Test(3 months after completing the intervention)
- Change in Nine Hole Pegboard Test(3 months after completing the intervention)
- Change in Beck Depression Inventory-II(3 months after completing the intervention)
- Change in Box and Block Test(3 months after completing the intervention)
- Change in Fugl-Meyer Assessment of Motor Recovery after Stroke(3 months after completing the intervention)
- Change in Grip Strength in Kgs(3 months after completing the intervention)
- Change in Chedoke Arm and Hand Activity Inventory(3 months after completing the intervention)
- Change in Behaviour Rating Inventory of Executive Function(3 months after completing the intervention)
- Change in Figural Memory Subtest(3 months after completing the intervention)
- Change in Apathy Evaluation Scale(3 months after completing the intervention)
- Change in Profile of Mood States(3 months after completing the intervention)
- Change in Stroke Impact Scale(3 months after completing the intervention)
研究者
Antoni Rodriguez Fornells
Research Professor in Catalan Institution for Research and Advanced Studies
University of Barcelona