Comparative Study on Mirror Therapy With a Rehabilitation Device for Training of Affected Fingers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Jebsen-Taylor Hand Function Test score
研究概览
简要总结
This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week.
详细描述
The investigators hypothesize that the physical MT with Miraπ with physical movement of the affected hand will be generating a better patient outcome than conventional MT. Until now MT is performed in front of a mirror with the help of an occupational therapist, which can prove to be difficult. The affected hand of the patient is not moved during training. For the reasons mentioned, the mirror therapy device MIRAπ was developed. With MIRAπ, no mirror is needed and the affected hand is also physically moved by the device. Therefore, this clinical trial will focus on evaluating the device to see if it works better than conventional MT and therefore creates greater benefits to the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Participants currently accepted and cleared for rehabilitation in the inpatient rehabilitation unit by the rehabilitation medical director.
- •Participants with paralysis or motor function problems of only one hand.
- •Participants spasticity of the affected hand ( as assessed by by the occupational therapist)
- •Participants need mirror therapy because of their health condition.
- •Participants are able to memorize easy tasks, and able to follow instructions e.g., moving the healthy fingers.
排除标准
- •Participants who are not cleared physically or medically to participate in standard acute inpatient rehabilitation therapies by the rehabilitation medical director
- •Participants who are not able to memorize easy tasks, e.g., moving the healthy fingers.
- •Participants with spasticity of the affected hand ( as assed by the occupational therapist)
- •Vulnerable populations
研究组 & 干预措施
Conventional Therapy Group
Participants in this group with train using Mirror Therapy (MT), the current standard of care.
干预措施: Mirror Therapy (Behavioral)
Miraπ Group
Participants in this group will train with the Miraπ device.
干预措施: Miraπ (Device)
结局指标
主要结局
Change in Jebsen-Taylor Hand Function Test score
时间窗: At admission and discharge up to 4 weeks
Percentage score, which determines how well a participant can do motor tasks for range of motion, strength, and tasks of activities of daily life. Participants have up to 120 seconds to complete tasks. Lower scores indicate less impairment.
次要结局
未报告次要终点