跳至主要内容
临床试验/NCT03503617
NCT03503617已完成不适用

RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke

Flint Rehabilitation Devices, LLC2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy

研究概览

简要总结

We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 to 85 years old
  • Upper extremity weakness measured by a clinical scale
  • Absence of moderate to severe pain on affected upper extremity
  • Able to understand the instructions to operate RehabTouch

排除标准

  • Concurrent severe medical problems, visual deficits, severe neglect or apraxia
  • Enrollment to other therapy studies

结局指标

主要结局

Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy

时间窗: From Baseline to One-month Post-therapy

The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.

次要结局

  • Change in Box and Blocks Test Score(From Baseline to One-month Post-therapy)
  • Motor Activity Log(One-month Post-therapy)
  • Visual Analog Pain Scale(From Baseline to One-month Post-therapy)
  • 10 Meter Walk Test(From Baseline to One-month Post-therapy)
  • Modified Ashworth Spasticity Scale(From Baseline to One-month Post-therapy)

研究者

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

Flint Rehabilitation Devices, LLC

Vice President

Flint Rehabilitation Devices, LLC

研究点 (2)

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