跳至主要内容
临床试验/NCT02729649
NCT02729649已完成不适用

ArmAssist Robotic Device for Arm Training

University of Belgrade2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Fugl Mayer motor score for upper extremity

研究概览

简要总结

ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.

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

性别
All
接受健康志愿者

入选标准

  • unilateral paresis;
  • ability to understand and follow simple instructions;
  • minimum ability to perform active movements, even though trunk compensation, using the shoulder and/or the elbow joints.

排除标准

  • bilateral impairment;
  • severe sensory deficits in the paretic upper limb;
  • cognitive impairment or behavioral dysfunction that would influence the ability to understand or perform the experiment;
  • inability to provide informed consent;
  • other current severe medical problems.

结局指标

主要结局

Fugl Mayer motor score for upper extremity

时间窗: 4 weeks

次要结局

  • Action research arm score(4 weeks)
  • Ashworth score(4 weeks)
  • Wolf motor function test(4 weeks)
  • Barthel index(4 weeks)

研究者

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

Konstantinovic Ljubica

professor

University of Belgrade

研究点 (2)

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