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临床试验/NCT01157195
NCT01157195已完成不适用

Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年6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
已完成
入组人数
25
试验地点
1
主要终点
Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks

研究概览

简要总结

Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical rehabilitation derived from basic behavioral and neuroscience research. It has been shown to be efficacious for rehabilitating use of the more-affected arm in individuals more than one year after stroke with mild to moderate motor impairment. The first component of the therapy is intensive training in use of the more-affected arm on functional tasks for 3 hours daily for 10 consecutive weekdays. The second is wearing a protective safety mitt on the less-affected hand for all waking hours of the approximately 2-week treatment period that it is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The third is a group of behavioral techniques designed to transfer gains from the treatment setting to the real world, which takes a therapist, on average, 30 minutes to implement on each treatment day.

The purpose of this project is to develop and test a method for automating the delivery of this efficacious treatment in a way that the therapy can be provided in stroke patients' homes. After developing an automated CI therapy workstation that has tele-health capabilities, the investigators will conduct a randomized controlled trial to evaluate whether CI therapy delivered in the home using this workstation with remote supervision by a therapist via an Internet-based audiovisual link provides outcomes that are just as good as CI therapy delivered by a "live" therapist.

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
None

入排标准

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

入选标准

  • •more than 1 year after stroke
  • •some ability to voluntarily open fingers on more affected side of body
  • •some ability to voluntarily raise wrist on more affected side of body
  • •ability to stand independently for two minutes
  • •ability to transfer from sit to stand independently

排除标准

  • •serious, concurrent medical conditions including frailty
  • •excessive spasticity (high muscle tone) in more affected arm
  • •impairment in thinking that makes compliance with study activities difficult

研究组 & 干预措施

CI therapy

Active Comparator

干预措施: CI therapy (Behavioral)

Tele-AutoCITE

Experimental

AutoCITE stands for Automated Constraint Induced Therapy Extender.

干预措施: Tele-AutoCITE (Behavioral)

结局指标

主要结局

Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks

时间窗: Baseline to 2 weeks (average)

Well-validated structured interview that assesses how much and how well the more-affected arm after stroke has been used to accomplish everyday activities over a specified period.

次要结局

  • Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks(Baseline to 2 weeks (average))
  • Change in MAL Arm Use Scale at 12 months(Baseline to 12 months (average))
  • Change in MAL Arm Use Scale at 6 months(Baseline to 6 months (average))

研究者

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

Gitendra Uswatte

Associate Professor of Psychology

University of Alabama at Birmingham

研究点 (1)

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