Effects of Rhythmic Auditory Stimulation on Upper-limb Movements, Function, and Quality of Life in Stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Nine-Hole Peg Test
研究概览
简要总结
The goal of this study is to to examine whether rhythmic auditory stimulation improved movement speed, movement function of executing activities of daily living, and movement recovery of the affected upper limb, as well as quality of life in stroke patients. The main questions it aims to answer are:
- Does rhythmic auditory stimulation improve movement speed in stroke patients?
- Does rhythmic auditory stimulation improve movement function of executing activities of daily living in stroke patients?
- Does rhythmic auditory stimulation improve movement recovery of the affected upper limb in stroke patients?
- Does rhythmic auditory stimulation improve quality of life in stroke patients?
Researchers will compare movement training with the aid of rhythmic auditory stimulation to movement training without the aid of rhythmic auditory stimulation to see if rhythmic auditory stimulation works to improve movement speed, movement function of executing activities of daily living, and movement recovery of the affected upper limb, as well as quality of life in stroke patients.
Participants will:
- Undergo movement tests and fill out questionnaires before and after the movement training program
- Receive movement training for 40 minutes per session and three sessions per week for a total of 24 sessions
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)
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
- •(1) Diagnosed with either ischaemic or hemorrhagic stroke, and a first-time occurrence;
- •(2) A unilateral stroke;
- •(3) The onset occurred six months or more prior to the experiment, indicating a chronic stage of stroke;
- •(4) The affected upper limb's proximal and distal joints are between Brunnstrom stages four to six, ensuring that the affected limb can execute the upper-limb functional movement training of this study;
- •(5) The affected upper limb's Modified Ashworth Scale score is ≤ 2, indicating no significant muscle stiffness (spasticity) in the affected limb;
- •(6) A Montreal Cognitive Assessment score of ≥ 24, ensuring comprehension of the instructions given during this study;
- •and (7) when we clap hands next to the affected ear of the participant who closes eyes, the participant is able to indicate the sound's source either verbally or through gestures, indicating no complete hearing loss in the affected ear and the ability to receive rhythmic auditory stimulation.
排除标准
- •(1) Neurological diseases or medical conditions that affect upper-limb movements or hearing;
- •(2) Being participating in other experimental studies related to drug treatment or upper-limb movement therapy.
结局指标
主要结局
Nine-Hole Peg Test
时间窗: Up to 1 week right after the last session of the intervention
A larger value (the recorded time for completing the task) means a slower movement.
Box and Block Test
时间窗: Up to 1 week right after the last session of the intervention
A larger value (the number of blocks) means a faster movement.
次要结局
- Jebsen-Taylor Hand Function Test(Up to 1 week right after the last session of the intervention)
- the Fugl-Meyer Assessment(Up to 1 week right after the last session of the intervention)
- the Stroke Impact Scale(Up to 1 week right after the last session of the intervention)
研究者
Shu-Mei Wang
Dr.
National Taipei University of Nursing and Health Sciences