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临床试验/NCT04536987
NCT04536987已完成2 期

Robot Therapy for Rehabilitation of Hand Movement After Stroke

The Catholic University of America2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年10月4日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
15
试验地点
2
主要终点
Change in Fugl-Meyer Test of Motor Function

研究概览

简要总结

A study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. One group will receive 12 sessions of robot-assisted repetitive movement practice in the HEXORR robot over a 4-5 week period. A second group will receive 24 sessions of HEXORR therapy over a 8-10 week period.

详细描述

The overall goal of the proposed work is to improve hand function after stroke. Adequate hand function is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, involuntary activation of flexors and inability to activate extensors. The rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. The key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. While these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. There is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. In these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.

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
Single (Outcomes Assessor)

盲法说明

Staff performing clinical evaluations was unaware of the study design.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a diagnosis of stroke more than 6 months prior to randomization
  • presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
  • adequate cognitive status, as determined by Mini-Mental Status Examination score >24

排除标准

  • were under the influence of oral or injected antispasticity medications during the study
  • had MCP and IP passive extension limit > 30 degrees from full extension
  • had pain that interfered with daily activities
  • had excessive tone in the fingers and thumb as determined by Ashworth scores >=3
  • had severe sensory loss or hemispatial neglect as determined by clinical exam.

结局指标

主要结局

Change in Fugl-Meyer Test of Motor Function

时间窗: 6 month follow-up

Measures motor impairment in the upper extremity after stroke

次要结局

  • Change in Modified Ashworth Test(6 month follow-up)
  • Change in finger extension range of motion (degrees)(6 month follow-up)
  • Change in Motor Activity Log(6 month follow-up)
  • Change in Grip Strength(6 month follow-up)
  • Change in Action Research Arm Test(6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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