跳至主要内容
临床试验/NCT05180812
NCT05180812进行中(未招募)不适用

Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

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

Experimental

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

Sham Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Lanphier Patton

Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab

Shirley Ryan AbilityLab

研究点 (1)

Loading locations...

相似试验