跳至主要内容
临床试验/NCT02096445
NCT02096445已完成不适用

Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Roger Gassert2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Motor impairment of the upper limb

研究概览

简要总结

The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.

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

入选标准

  • age between 18-90 years old
  • hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
  • sub-acute lesion not more than 6 weeks post ictus

排除标准

  • insufficient state of consciousness
  • severe aphasia
  • severe cognitive deficits
  • severe pathologies of the upper extremity of traumatic or rheumatic nature
  • severe pain in the affected arm
  • Patients with pacemakers and other active implants

结局指标

主要结局

Motor impairment of the upper limb

时间窗: Change from Baseline in motor impairment of the upper limb at 4 weeks

Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)

次要结局

  • Spasticity level of the upper limb(Change from Baseline in spasticity level of the upper limb at 6 months)
  • Neglect(Change from Baseline in neglect at 6 months)
  • Cognitive impairment(Change from Baseline in cognitive impairment at 6 months)
  • Functional improvement in dexterity(Change from Baseline in functional improvement of dexterity of the upper limb at 6 months)
  • Motor impairment of the upper limb(Change from Baseline in motor impairment of the upper limb at 6 months)
  • Frontal lobe function(Change from Baseline in frontal lobe function at 6 months)
  • Tactile and proprioceptive sensory function of the upper limb(Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months)
  • Aphasia(Change from Baseline in aphasia at 6 months)
  • Attention(Change from Baseline in attention at 6 months)

研究者

发起方
Roger Gassert
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Roger Gassert

Prof. Dr.

Swiss Federal Institute of Technology

研究点 (2)

Loading locations...

相似试验