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临床试验/NCT03005457
NCT03005457已完成不适用

A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis

Ohio State University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年7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
32
试验地点
1
主要终点
Change in Motor Activity Log

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Stroke

Experimental

干预措施: Hemiparesis Therapy with VR (Behavioral)

Hemiparesis other

Experimental

干预措施: Hemiparesis Therapy with VR (Behavioral)

结局指标

主要结局

Change in Motor Activity Log

时间窗: Week 0 and Week 3

Self-report measure of arm use for daily activities

Change in Wolf Motor Function Test

时间窗: Week 0 and Week 3

Objective measure of motor function in a laboratory setting

次要结局

  • Weschler Adult Intelligence Scale Symbol Seach(Week 0 and Week 3)
  • Action Research Arm Test (ARAT)(Week 0 and Week 3)
  • Montreal Cognitive Assessment(Week 0 and Week 3)
  • Bilateral activity monitors(Week 0 and Week 3)
  • Patient Health Questionnaire(Week 0 and Week 3)
  • Strok Specific Quality of Life Scale(Week 0 and Week 3)
  • Kinematic Data(Week 0 and Week 3)
  • Survey(Week 0 and Week 3)
  • Mitt Compliance(Week 0 and Week 3)
  • Brief Kinesthesia test(Week 0 and Week 3)
  • Total game-play time(Week 0 and Week 3)
  • Gestures(Week 0 and Week 3)

研究者

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

Lynne Gauthier , PhD

Assistant Prof. PM&R

Ohio State University

研究点 (1)

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