Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 222
- 试验地点
- 6
- 主要终点
- Intrinsic Motivation Inventory (IMI) questionaire
研究概览
简要总结
Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke, spinal cord injury)
详细描述
Neurological patients (e.g., after stroke) need long-term neurorehabilitative therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitative training. Investigators aim at developing a unique intensified and patient-tailored robot-aided training strategy of the arm. The exoskeleton robot ARMin will be further developed to adapt software components accordingly. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. It can be intensified by different strategies that will be evaluated alone and in combination. These strategies include:
strength training an error-amplification strategy increased number of repetitions multisensory feedback multiplayer approach
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy or CVA or spinal cord injury
- •Aged ≥18 years
- •No excessive spasticity of the affected arm (modified Ashworth Scale ≤3)
- •No serious medical or psychiatric disorder as assessed by their physician
- •No orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
- •No shoulder subluxation (palpation <2 fingers)
- •No skin ulcerations at the paretic arm
- •Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised
- •No cybersickness (e.g., nausea when looking at a screen or playing computer games)
- •No pacemaker or other implanted electric devices
- •Bodyweight <120 kg
- •No serious cognitive defects or aphasia preventing effective use of ARMin
- •Exclusion Criteria
- •Allergy against alcohol or no agreement for skin shaving
排除标准
- 未提供
结局指标
主要结局
Intrinsic Motivation Inventory (IMI) questionaire
时间窗: within one day
The IMI is a multidimensional measurement device that assesses participants' interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity, thus yielding six subscale scores
次要结局
- performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm)(within one day)
- performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm)(within one day)
- detection thresholds (time)(within one day)
- muscle strength in Nm(within one day)
- EMG for muscle activity (time and electric potential)(within one day)
- EMG for muscle activity (electric potential in V)(within one day)
- performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec)(within one day)
- questionaire on interaction, time and effort(within one day)
- EMG for muscle activity (time in sec)(within one day)
- detection thresholds (position in cm)(within one day)