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临床试验/NCT02706912
NCT02706912已完成不适用

Virtual Occupational Therapy Application

Barron Associates, Inc.2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年2月最近更新:
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
22
试验地点
2
主要终点
Fugl-Meyer upper extremity assessment

研究概览

简要总结

Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking, commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in a computer-based virtual world in which stroke patients practice activities of daily living (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE) motor recovery and assesses system usability and user acceptance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Participant is a hemiparetic stroke survivor;
  • Time since last stroke at least 3 months;
  • Participant has antigravity strength at the elbow to at least 45 degrees of active flexion in the stroke affected arm;
  • Participant has antigravity shoulder strength to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active rotation from an upright seated position in the stroke affected arm;
  • Participant has visual acuity with corrective lenses of 20/50 or better;

排除标准

  • Existing participation in an upper extremity stroke rehabilitation program or planned participation during the study period;
  • Inability to understand and follow verbal directions;
  • Determination that participation would result in over exertion or significant discomfort or pain;
  • Determination that participation would result in significant agitation or elevated stress;
  • Withholding or withdrawal of consent by the participant;
  • Visual field deficit in either eye that impairs the ability to view the computer monitor;
  • Hemispatial neglect that impairs the ability process and perceive visual stimuli provided through the computer monitor;

研究组 & 干预措施

VOTA Group

Experimental

All enrolled subjects are in this arm. After pre-assessment subjects have an 8-week waiting period, after which a mid-assessment takes place. Subject then participate in VOTA therapy for 8 weeks, followed by a post-assessment . The pre-/mid-assessment difference is used to control for spontaneous recovery. The mid-/post-assessment difference is used to ascertain efficacy.

干预措施: VOTA Therapy (Behavioral)

结局指标

主要结局

Fugl-Meyer upper extremity assessment

时间窗: Pre-assessment and Post-assessment (8 weeks)

Measure of upper extremity motor function

次要结局

  • Trail Making Test(Pre-assessment and Post-assessment (8 weeks))
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Pre-assessment and Post-assessment (8 weeks))
  • Wolf Motor Function Test(Pre-assessment and Post-assessment (8 weeks))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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