Clinical Feasibility of ROBERT-SAS in Severely Impaired Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- System Usability Scale (SUS) score
研究概览
简要总结
Robotic training can be used to provide intensive training during the (early phases of) rehabilitation of a stroke. ROBERT®-SAS training is designed to create an active and intensive training tool for the rehabilitation of the lower extremity of stroke patients. Currently this has only be tested in a lab-based setting, which showed that is was feasible and could be executed while still being comfortable for the patient. The next step will be implementing the device in a clinical setting. Therefore, aims the current study to assess the feasibility of ROBERT®-SAS training in clinical setting, in acute stroke patients.
详细描述
Rationale: Stroke is one of the leading causes of disability of adults in the European Union. Around 80% of stroke survivors experience deficits in motor control, resulting in problems with keeping balance and walking, for instance. The extent and amount of deficits differ per individual. Interventions to train the lower extremity almost always consist of walking exercises. However, patients in the acute phase or with severely affected lower extremity function are often unable to walk or to walk independently. Therefore, the combination of a robot (ROBERT®) and functional electrical stimulation (ES) is being developed to provide a training tool for early rehabilitation. In the current study a combination of robot and ES will be evaluated in clinical setting.
Objective: The primary objective of the current study is to assess the feasibility of ROBERT®-SAS training in clinical setting, in acute stroke patients, including patient and therapist perspectives.
Study design: The current study is an observational study.
Study population: In the current study ten (sub) acute stroke patient will be included, with severely affected lower extremity. Five of these ten will be included as soon as possible after arrival at the rehabilitation centre. Another five will be included 3-5 weeks after arrival/start of the rehabilitation.
Main study parameters/endpoints: The main outcome parameter is the SUS score from both the patients and the therapists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sub(acute) stroke (< 6 months post-stroke)
- •Above 18 years
- •Able to provide informed consent
- •An ischemic or haemorrhagic stroke
- •Hemiparetic lower extremity
排除标准
- •Premorbid disability of lower extremity
- •Severe cognitive impairment, unable to follow simple instructions and unable to understand Dutch.
- •Skin lesions at the hemiparetic leg
- •Progressive neurological diseases (i.e. Parkinson, dementia, etc.)
- •Contraindication for mobilization like unhealed lower limb fracture
- •Use of pacemaker
结局指标
主要结局
System Usability Scale (SUS) score
时间窗: 15 minutes
The System Usability Scale of patients and therapists. 10 questions with a 5-point response scale. The total score can range from 0 - 100, in which a higher score indicates a better usability
次要结局
- Frequency(30 minutes)
- Motricity Index (MI)(10 minutes)
- Amplitude of the electrical stimulation(30 Minutes)
- Resistance level(30 minutes)
- Fugl-Meyer Assessment (FMA)(10 minutes)
- Amount of repetitions(30 minutes)
- Force(30 minutes)
- Assist-As-Needed (AAN) stages(30 minutes)
- Type of movement(30 minutes)
- Pulse width of the electrical stimulation(30 minutes)
- Electromyography (EMG)(30 minutes)
- Functional Ambulation Categories (FAC)(5 minutes)
- Questionnaire Experience(15 minutes)