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临床试验/NCT04565639
NCT04565639已完成不适用

Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

Liberating Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年8月14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
3
试验地点
2
主要终点
Sustained grip strength

研究概览

简要总结

The primary objective of this study is to evaluate pinch strength improvements and improvements in coordination and functional ability. Pinch strength measurements are made on subjects both with and without the device to evaluate the potential improvements. Also, coordination and functional testing is performed both with and without the device to compare performance under both conditions and evaluate potential improvement.

详细描述

This study tests the powered hand orthosis device on a small number of participants (up to 6). Research participants with neuromusculoskeletal impairments were recruited for the study and consented with an approved protocol. The study was conducted during 1 visit to LTI in Holliston, MA . The study consists of several assessments. Participants are surveyed for cognitive limitations and self-assessment of difficulties in completing tasks of daily living by completing surveys such as the Quickdash Questionnaire [1], the Mini-Mental State test [2], and the McGann Feedback form [3]. Pinch strength without and with the powered orthosis is evaluated. A selection of functional outcome measures are performed such as the Southampton Hand Assessment Procedure (SHAP) [4], the Nine-Hole Peg Test (NHP) [5], and the Box and Blocks Test (BBT) [6].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Sustained grip strength

时间窗: 1 minute

The sustained grip available for achieving activities of daily living that require a sustained grip

次要结局

  • Maximum Grip Strength(10 seconds)
  • Accomplishing activities of daily living(10 minutes)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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