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临床试验/DRKS00030586
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

Schön Klinik Bad Aibling0 个研究点目标入组 120 人开始时间: 2022年10月24日最近更新:
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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