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临床试验/NCT02072369
NCT02072369已完成不适用

Simulated Home Therapy Program for the Hand After Stroke

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
The Action Research Arm Test (ARAT)

研究概览

简要总结

The purpose of this study is to investigate the benefits of incorporating an actuated, EMG-controlled glove into occupational therapy of the hand.

详细描述

Stroke survivors with chronic hemiparesis of the upper extremity undertook 18 one-hour training sessions over a 6-week period. Participants received occupational therapy focusing on grasp-and-release using a task-oriented protocol developed at the Rehabilitation Institute of Chicago by Dr. Mary Ellen Stoykov. Over 90% of all repetitions performed during each session were focused on functional activities, as opposed to active exercise. The skills and strategies developed in therapy were then implemented into activities identified as goals by the participant, such as donning socks. Difficulty of the task, activity, or exercise was progressed for each participant to provide optimal challenge to enhance skill.

Subjects were assigned to one of two groups by casting lots. One group (VAEDA Glove) performed all tasks while wearing a custom Voice And EMG-Driven Actuated glove, the VAEDA Glove. The other group (No-Glove) performed the same types of tasks without use of the VAEDA Glove. The VAEDA Glove is a portable active-assistance glove, designed to assist digit extension in order to allow repeated practice of specified tasks. The glove contains cables traversing the dorsal side of the digits in order to provide extension and resist flexion. Forces are transmitted through the cables from a servomotor located remotely to the digits. The servomotor controls torque or displacement in the cable. Along the digits, the cables traverse through custom plastic blocks, which serve both to guide the cable and to prevent joint hyperextension.

The VAEDA Glove can be controlled with up to 3 channels of electromyography (EMG). For this study, electrodes were placed above flexor digitorum superficialis (FDS) and extensor digitorum communis (EDC). The group using the J-Glove could receive assistance during hand opening, but only if appropriate EMG activity was detected. The EDC EMG activity had to reach a prescribed threshold before extension assistance would be provided. Similarly, FDS EMG activity had to surpass a threshold level during hand closing before the user was allowed to flex the digits. Feedback of muscle activity was available to the user through a custom graphical user interface.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

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

  • chronic upper extremity hemiparesis subsequent to stroke (minimum of 6 months post-stroke)
  • moderate hand impairment classified as Stage 4 on the Chedoke McMaster Stroke Assessment

排除标准

  • anti-spasticity medications/injections taken less than 6 month prior to enrollment
  • contractures greater than 20 degrees
  • inability to follow single-step commands
  • significant upper extremity pain (self-reported pain of greater than 6 on a 10-point scale)

结局指标

主要结局

The Action Research Arm Test (ARAT)

时间窗: Change from Baseline after 6 weeks of training

Fugl-Meyer Upper Extremity Motor Assessment (FMUE)

时间窗: Change from Baseline to 1 month following training completion

Chedoke McMaster Stroke Assessment Stage of Hand (CMSA-H)

时间窗: Change from Baseline to 1 month following training completion

Action Research Arm Test (ARAT)

时间窗: Change from Baseline to 1 month following training completion

Wolf Motor Function Test (WMFT)

时间窗: Change from Baseline to 1 month following training completion

次要结局

  • 3-point (palmar) Pinch Strength (PPS)(Change from Baseline after 6 weeks of training and 1 month follow up)
  • Lateral Pinch Strength (LPS)(Change from Baseline after 6 weeks of training and 1 month follow up)
  • Hand Kinematics(Change from Baseline after 6 weeks of training and 1 month follow up)
  • Grip Strength (GS)(Change from Baseline after 6 weeks of training and 1 month follow up)

研究者

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

Derek Kamper

Research Scientist, SMPP, RIC

Shirley Ryan AbilityLab

研究点 (2)

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