Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
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
- 否
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
Roger Gassert
Prof. Dr.
Swiss Federal Institute of Technology
