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临床试验/NCT00396708
NCT00396708已完成不适用

Wearable Robotic Functional Assistance for Stroke Rehabilitation

Myomo2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Myomo
入组人数
20
试验地点
2
主要终点
Motor Activity Log

研究概览

简要总结

This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.

详细描述

This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.

The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.

Study procedures will focus on performing functional tasks using the e100.

研究设计

研究类型
Interventional
分配方式
Randomized
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

入选标准

  • Medically Stable
  • Cognitive Awareness
  • Weakness in upper arm
  • Over 1 year post CVA
  • not engaged in any other upper arm therapies

排除标准

  • Rashes, open wounds or skin sensitivity on arm
  • Very high elbow tone (arm rigid in flexion or extension)

结局指标

主要结局

Motor Activity Log

Fugl-Meyer Upper Arm Function

Wolf Motor Function

SF-36 QOL Survey

Range of Motion

Muscle Strength Test

次要结局

未报告次要终点

研究者

发起方
Myomo
申办方类型
Industry

研究点 (2)

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