跳至主要内容
临床试验/NCT05598892
NCT05598892已完成不适用

Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study

Corporación de Rehabilitación Club de Leones Cruz del Sur2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4
试验地点
2
主要终点
Dynamometry - Grip Baseline

研究概览

简要总结

The following study seeks to provide information regarding to the RobHand exoskeleton for hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid, Spain.

详细描述

The following study seeks to provide information regarding to the RobHand exoskeleton for hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid, Spain. The study was carried out by the Neurotchnology Group of the Research and Development Area of the Corporación de Rehabilitación Club de Leones Cruz del Sur, Chile. Clinical test were implemented on four subjects with Stroke sequelae who participated in two evaluations of manual function and 16 training sessions with the robotic exoskeleton, in order to know the clinical effects on manual function, safety and satisfaction of users who utilize the exoskeleton RobHand.

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

入选标准

  • Over 18 years old
  • Active patient at the Rehabilitation Center Club de Leones Cruz del Sur
  • At least 1 Hemorrhagic or ischemic stroke
  • Adequate level of consciousness
  • Paresis of the upper extremities
  • Patient who signed the inform consent

排除标准

  • Comorbidities in the central nervous system
  • Pain in the upper extremity (hand, forearm, arm)
  • Patient who does not sign the informed consent

结局指标

主要结局

Dynamometry - Grip Baseline

时间窗: Baseline

A Jamar hydraulic hand dynamometer (Pennsylvania, USA) was used to assess isometric contractions. This test allows to evaluate the functional integrity of the upper extremity through the force exerted when squeezing the hand and therefore,to identify the loss of physiological muscle function. The patient is asked to grasp the resistance of the handle, place his shoulder in abduction and with neutral rotation. Additionally, the elbow must be flexed at 90º and with the forearm in a neutral position.

Dynamometry - Grip Post Intervention

时间窗: 8 weeks

A Jamar hydraulic hand dynamometer (Pennsylvania, USA) was used to assess isometric contractions. This test allows to evaluate the functional integrity of the upper extremity through the force exerted when squeezing the hand and therefore,to identify the loss of physiological muscle function. The patient is asked to grasp the resistance of the handle, place his shoulder in abduction and with neutral rotation. Additionally, the elbow must be flexed at 90º and with the forearm in a neutral position.

次要结局

  • Nine Hole Peg Test (9-HPT) Post Intervention(8 weeks)
  • Nine Hole Peg Test (9-HPT) Baseline(Baseline)

研究者

发起方
Corporación de Rehabilitación Club de Leones Cruz del Sur
申办方类型
Other
责任方
Sponsor

研究点 (2)

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