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临床试验/NCT03713476
NCT03713476已完成不适用

Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation for Upper Extremity Function of Stroke Patients

National Cheng-Kung University Hospital2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年12月3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
38
试验地点
2
主要终点
Change in the result of Box and blocks test

研究概览

简要总结

In the proposed study, the investigators assumed that using robot assisted tenodesis-grip training providing high does assisted grip movement may do the effects on motor shaping and greater brain priming for hand paresis of the stroke patients. The specific aim of this study is to examine the difference in the treatment effects between the combination of robot assisted tenodesis-grip training with task-oriented training and combination of traditional occupational therapy with task-oriented training on the motor, sensation, hand performance of the stroke patients. The expected outcomes of this research are to help the clinicians understand the training mechanism and effects of robot assisted tenodesis-grip training on functional performance of upper extremity for unilateral stroke patients.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of stroke with unilateral side involved;
  • Stroke at least 7 days before the start of the first assessment session;
  • A score of Mini-mental state examination greater than 24 for proving higher mental function;
  • Premorbid right-handedness.

排除标准

  • Uncontrolled hypertension;
  • Major cognitive-perceptual deficit;
  • Other brain disease.

结局指标

主要结局

Change in the result of Box and blocks test

时间窗: baseline, 6 weeks and 18 weeks

The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.

Change in the result of Semmes-Weinstein monofilament (SWM) test

时间窗: baseline, 6 weeks and 18 weeks

The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.

Change in the result of Motor Activity Log

时间窗: baseline, 6 weeks and 18 weeks

MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.

Change in the result of Fugl-Meyer assessment for UE motor function

时间窗: baseline, 6 weeks and 18 weeks

Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.

Change in the result of Modified Ashworth scale (MAS)

时间窗: baseline, 6 weeks and 18 weeks

Muscle tone is defined by the resistance of a muscle being stretched without resistance.

次要结局

  • Clinical global impression scale(post-intervention (week 6))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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