Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy
2016年12月25日 更新者：Lynne Gauthier , PhD、Ohio State University
A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis
Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy.
Pre/post study design.
Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit).
Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.
研究概览
研究类型
介入性
注册 (实际的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University, 2154 Dodd Hall
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female aged > 17
- Preserved ability to comprehend English and participate in basic elements of the therapy
- Community-dwelling
- Experienced mild to moderate hemiparesis at least six months prior
- Can independently operate the gaming system (those with severe cognitive impairments can usually achieve this)
- Corrected vision of at least 20/70 as assessed by their ability to identify game objects on the monitor from 5 feet away
Exclusion Criteria:
- concurrent participation in other experimental upper extremity trials
- concurrent participation in other outpatient rehabilitation for their upper extremity
- Botox within the last 3 months (confound)
- near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample)
- minimal nonuse (Motor Activity Log at baseline >2.5, Accelerometry > 60%)
- major medical issues that would interfere with study treatments or make intensive rehabilitation difficult to tolerate
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：中风
|
An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids
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实验性的：Hemiparesis other
|
An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Motor Activity Log
大体时间：Week 0 and Week 3
|
Self-report measure of arm use for daily activities
|
Week 0 and Week 3
|
|
Change in Wolf Motor Function Test
大体时间：Week 0 and Week 3
|
Objective measure of motor function in a laboratory setting
|
Week 0 and Week 3
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Kinematic Data
大体时间：Week 0 and Week 3
|
Kinematic data recorded during game play
|
Week 0 and Week 3
|
|
Brief Kinesthesia test
大体时间：Week 0 and Week 3
|
Clinical Assessment of sensation
|
Week 0 and Week 3
|
|
Patient Health Questionnaire
大体时间：Week 0 and Week 3
|
Measures Depression
|
Week 0 and Week 3
|
|
Strok Specific Quality of Life Scale
大体时间：Week 0 and Week 3
|
Quality of life measurement
|
Week 0 and Week 3
|
|
Weschler Adult Intelligence Scale Symbol Seach
大体时间：Week 0 and Week 3
|
Cognitive processing speed assessment
|
Week 0 and Week 3
|
|
Montreal Cognitive Assessment
大体时间：Week 0 and Week 3
|
Baseline cognitive screen
|
Week 0 and Week 3
|
|
Survey
大体时间：Week 0 and Week 3
|
Survey on satisfaction with the intervention
|
Week 0 and Week 3
|
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Mitt Compliance
大体时间：Week 0 and Week 3
|
Hours of use
|
Week 0 and Week 3
|
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Total game-play time
大体时间：Week 0 and Week 3
|
Week 0 and Week 3
|
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Gestures
大体时间：Week 0 and Week 3
|
Number of gestures of each type registered in game
|
Week 0 and Week 3
|
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Bilateral activity monitors
大体时间：Week 0 and Week 3
|
Objective measure of arm use
|
Week 0 and Week 3
|
|
Action Research Arm Test (ARAT)
大体时间：Week 0 and Week 3
|
Asses Changes in Limb Function
|
Week 0 and Week 3
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年7月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2016年12月21日
首先提交符合 QC 标准的
2016年12月25日
首次发布 (估计)
2016年12月29日
研究记录更新
最后更新发布 (估计)
2016年12月29日
上次提交的符合 QC 标准的更新
2016年12月25日
最后验证
2016年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.