Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity
研究概览
简要总结
Background and Study Aims Stroke is a leading cause of long-term disability worldwide, affecting millions of individuals each year. After experiencing a stroke, many patients face challenges with their upper limbs, resulting in difficulties in performing daily activities. This study aims to evaluate a new rehabilitation device designed to assist stroke patients with hemiparesis (weakness on one side of the body) in improving their upper limb function. The goal is to determine if this device can effectively support recovery while providing an affordable and accessible option for rehabilitation.
Who Can Participate? This study is open to adults aged between 18 and 70 years, regardless of sex. To participate, individuals must have a confirmed diagnosis of hemiplegic stroke, which means they must experience weakness in one side of the body. Participants should have had their stroke within the last 12 months and must be able to follow simple commands. Those with cognitive impairments, other neurological disorders, certain orthopedic conditions affecting the upper limb, or active skin issues will not be eligible.
What Does the Study Involve? Participants in this study will be randomly assigned to two groups: one group will use the new rehabilitation device, while the other will receive conventional occupational therapy. Both groups will undergo an assessment before and after the intervention to measure their improvement in upper limb function. The device encourages exercises that are essential for fostering movement recovery, while the conventional therapy focuses on traditional rehabilitation methods. Participants will have their upper limb function evaluated through established assessment tools to gauge progress.
What Are the Possible Benefits and Risks of Participating? By participating in this study, individuals may experience improvements in their upper limb function, leading to increased independence and enhanced quality of life. Additionally, participants will contribute to valuable research that could improve rehabilitation strategies for future stroke patients. While the rehabilitation device is designed to be safe, some individuals may experience mild discomfort or fatigue from the exercises. However, serious side effects are rare. Participants are encouraged to discuss any concerns with the research team.
Where Is the Study Run From? The study is being conducted at New Taipei Municipal TuCheng Hospital in Taiwan, specifically in the rehabilitation ward, where trained medical professionals oversee the research process.
When Is the Study Starting and How Long Is It Expected to Run For? The study commenced in September 2023 and is expected to continue through November 2024. This timeline allows for recruiting participants and thorough data collection to assess the device's effectiveness.
Who Is Funding the Study? This study does not have external funding and is being conducted independently by the researchers involved. All costs associated with the study, including participant care and device usage, are covered by the resources of the conducting institution.
Who Is the Main Contact?
For more information about this study, please contact:
Kuo-Cheng, Liu Position: Research Coordinator Email address: monhh159@gmail.com
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed stroke diagnosis by imaging, with onset within the past 12 months
- •Age between 18 and 70 years
- •Stable physiological and neurological status (no neurological deterioration and stable vital signs for ≥72 hours; complications resolved or medically managed)
- •Adequate cognitive function to follow at least two-step commands
- •Willingness to provide written informed consent
- •Unilateral upper extremity (UE) hemiplegia
- •Brunnstrom stage > I for proximal UE motor function
- •UE muscle tone < 3 on the Modified Ashworth Scale
排除标准
- •Cognitive impairment
- •Other neurological disorders
- •Orthopedic conditions affecting the UE
- •Active or non-healed dermatological lesions
研究组 & 干预措施
Control group
Intervention includes 30 minutes of UE functional training and 1 hour of conventional occupational therapy.
干预措施: Conventional occupational therapy (Other)
Control group
Intervention includes 30 minutes of UE functional training and 1 hour of conventional occupational therapy.
干预措施: The UE functional training (Other)
Experimental group
Intervention consists of 30 minutes of novel UE rehabilitation device training and 1 hour of conventional occupational therapy.
干预措施: Novel UE rehabilitation device training (Device)
Experimental group
Intervention consists of 30 minutes of novel UE rehabilitation device training and 1 hour of conventional occupational therapy.
干预措施: Conventional occupational therapy (Other)
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity
时间窗: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.
次要结局
- Brunnstrom stage(Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.)
- Modified Ashworth scale(Outcome measurements were performed at three stages: before, during (after the 5th training session), and after (immediately following the final session) the intervention.)