Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Action Research Arm Test
研究概览
简要总结
The purpose of this study is to evaluate the safety, feasibility, and preliminary efficacy of the ExoNET passive robotic device. It will provide upper-extremity gravity compensation for therapeutic movement retraining in the chronic post stroke patient population.
详细描述
The ExoNET, a passive robotic solution that provides a soft, biomimetic, and elastic alternative to robotics that embodies intelligence within the mechanical design. Several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization. Here, it is possible to have a simple reconfigurable system that can not only assist performance, but can also make training easier, faster, and more complete. This contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology.
The primary objective of this study is to evaluate the safety, feasibility and efficacy using the ExoNET. Specifically, investigators want to see if the ExoNET tuned to gravity support will lead to a reduction in bicep muscle activity and an increase in range of motion. To accomplish this aim, we plan to have participants perform reaching, arm elevation and flexion task exercises wearing the ExoNET. To achieve these goals, we will use a wearable activity tracker (MiGo), to detect the number of activities performed, a wearable surface EMG system (Delsys) on the bicep muscles and a markerless system called the Kinect (version 2) to collect distribution of motion.
Investigators hypothesize that individuals with post-stroke arm movement deficits treated with ExoNET gravity compensation will improve their ARAT measures more than controls receiving a sham treatment. Secondarily, treated subjects will improve in other clinical metrics and will make more movements than controls.
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
- Double (Participant, Outcomes Assessor)
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
- •Ischemic or hemorrhagic stroke (8 months post stroke)
- •Available medical records and radiographic information about lesion locations
- •Hemiparesis
- •Some degree of both shoulder and elbow movement capability
- •A "moderate" impairment (Fugl-Meyer score between 15-50)
排除标准
- •Individuals under the age of 18
- •Bilateral paresis
- •Shoulder pain and/or articular rigidity on the upper limb joint
- •Spasticity (Modified Ashworth Scale of 2)
- •Botox injection to the affected upper extremity within the previous 4 months
- •Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
研究组 & 干预措施
Experimental Group: Gravity Compensation
The participants will be wearing the ExoNet device tuned to gravity support.
干预措施: ExoNet Tuned to Gravity Support (Device)
Control Group: No Gravity Compensation
The participants will be wearing the ExoNet device, but it will not be tuned to gravity support.
干预措施: ExoNet Tuned to Gravity Support (Device)
结局指标
主要结局
Action Research Arm Test
时间窗: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
次要结局
- Box and Blocks(Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations))
- Wolf Motor Function Test(Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations))
- Fugl-Meyer(Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations))
研究者
James Lanphier Patton
Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
