DRKS00030586招募中未知
Exploring and evaluating solutions for providing wrist assistance using functional electrical stimulation and an active wrist robot within the ReHyb system - HRX1-FES Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Subacute and chronic patient after stroke in an inpatient rehabilitation centre,
- •Ischemic or hemorrhagic infarction,
- •Age >= 18 years,
- •Cognitively able to follow instructions,
- •Low level or no pain in wrist or fingers at rest (NRS < 4),
- •Functional impairments in wrist or fingers (MRC <=3),
- •Able to sit in a chair with the wrist position in the robotic device for the duration of the session (session < 2 hours),
- •Familiar with electrical stimulation,
- •Able to understand and accept their participation in one of the studies.
排除标准
- •robot-related exclusion criteria:
- •High level of pain in the wrist or hand resulting in the operator’s inability to position the user’s arm and hand in the HRX-1 device and flex or extend the user’s wrist more than 20 degrees while in the robot
- •Severe contractures or muscle tone resulting in the operator’s inability to position the user’s arm and hand in the HRX-1 device and flex or extend or rotate the user’s wrist more than 20 degrees while in the robot
- •Severe psychiatric disorder
- •FES-related exclusion criteria:
- •People with active implantable devices (e.g., pacemakers) or other metal implants within the area stimulated by the FES device
- •No motion or muscle contraction resulting from FES (atrophy)
- •Patients suffering from peripheral nerve damage (e.g., polyneuropathy)
- •Patients with severe epilepsy or frequent epileptic seizures in the past
- •Cancer or wounds in the FES application area
- •Other exclusion criteria:
- •Patient has no function AND no deep sensitivity in the fingers or wrist
研究者
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