The General Use of Robots in Stroke Recovery: the Anklebot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
研究概览
简要总结
The purpose of this study is to determine if isolated robot-assisted training of the ankle joint improves chronic hemiparetic gait in patients after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18 years of age or older
- •First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- •Cognitive function sufficient enough to understand experiments and follow instructions
- •Some amount of independent ambulation (with orthoses or walker)
排除标准
- •Botox treatment within 6-weeks of enrollment;
- •Fixed contraction deformity in the affected limb;
- •Complete and total flaccid paralysis of all lower extremity motor function;
- •Unable to ambulate except with the aid of another person
研究组 & 干预措施
seated robot-assisted ankle therapy
All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated robot-assisted ankle training with the MIT anklebot. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning.
干预措施: seated robot-assisted ankle therapy (Device)
结局指标
主要结局
Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
时间窗: baseline, discharge (week 6), 3 month FU (overall week 18)
Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).
次要结局
- Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.(baseline, discharge (week 6), 3 month FU (overall week 18))
- Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.(baseline, discharge (week 6), 3 month FU (overall week 18))
研究者
Bruce Volpe
Principal Investigator
Northwell Health