Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
研究概览
简要总结
The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.
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
- •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
- •Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
排除标准
- •Prior experience with robotic arm therapy
- •Fixed contraction of the affected limb
- •Complete flaccid paralysis of the affected limb
研究组 & 干预措施
IMT Robotic Arm Therapy: Aim training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.
干预措施: IMT Robotic Arm therapy (Device)
IMT Robotic Arm Therapy: Smoothness Training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.
干预措施: IMT Robotic Arm therapy (Device)
IMT Robotic Arm Therapy: Impairment training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.
干预措施: IMT Robotic Arm therapy (Device)
IMT Robotic Arm Therapy: Functional training
Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.
干预措施: IMT Robotic Arm therapy (Device)
结局指标
主要结局
Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
时间窗: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
次要结局
- Change from baseline in Kinematic Data(12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention))
- Change from baseline in Fugl Meyer Sensation Scale(12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention))
- Change from baseline in Fugl Meyer Proprioception Scale(12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention))
研究者
Bruce Volpe
Principal Investigator
Northwell Health