Randomized Clinical Trial of (PoRI) Post-Stroke Hand Rehabilitation Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (FMA) score
研究概览
简要总结
This randomized clinical trial compares the Portable Rehabilitation Interface (PoRI) device for rehabilitation of hand motor function in post-stroke patients with conventional hand therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 2 days and a maximum of 2 months have passed since the stroke event
- •0-3/5 muscle strength
- •Participants with paralysis or sensorimotor function problems of the fingers of one or both hands.
- •Participants must be able to fit their hand comfortably into the device.
排除标准
- •Less than 2 days or greater than 2 months have passed since the stroke event
- •4-5/5 muscle strength
- •Vulnerable populations.
- •Inability of fingers and wrist to stretch to neutral during passive range of motion
研究组 & 干预措施
Portable Rehabilitation Interface (PoRI)
Participants will receive 20-minute sessions, 3 times per week for 2 to 3 weeks using the PoRI
干预措施: Portable Rehabilitation Interface (PoRI) (Device)
Standard of care
Participants will receive 20-minute sessions, 3 times per week for 2 to 3 weeks using standard of care
结局指标
主要结局
Fugl-Meyer Assessment (FMA) score
时间窗: Baseline and Week 2-3
Fugl-Meyer Assessment (FMA) score to assess function with a total score of 100 points. Higher scores mean better recovery, with 0-50 indicating severe impairment and 95-100 showing minimal impairment in motor function, guiding rehabilitation progress.
Box-and-Block Tests (BBT) score
时间窗: Baseline and Week 2-3
A Box-and-Block Test (BBT) score is the total number of small blocks a person moves from one section of a divided box to another within 60 seconds. More blocks moved equals greater dexterity.
Visual Analog Scale (VAS) Pain score
时间窗: Baseline and Week 2-3
The VAS pain scale is a tool for assessing pain intensity. Participants will be asked to mark a point on a 100 mm horizontal line that represents the intensity of their pain. This line has two endpoints: 0: No pain and 100: Worst possible pain imaginable. The distance from the "0" to the mark is measured in millimeters with the resulting number (0-100) being the VAS pain score
Short Form McGill Pain Questionnaire (sfMPQ) score
时间窗: Baseline and Week 2-3
The sfMPQ is scored by summing the values of words that best describe a person's pain. The score ranges from 0 (no pain) to 45 (severe pain).
次要结局
- Device usability and accessibility survey(Week 2-3)