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临床试验/TCTR20180419004
TCTR20180419004已完成4 期

Effect of the Robotic-assisted Gait Training Device (Welwalk®) plus physiotherapy in improving the ambulatory function in sub-acute hemiplegic stroke patients: investigator- blinded, randomized controlled trial

/A0 个研究点目标入组 26 人开始时间: 2018年4月19日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20 Years 至 79 Years(—)
性别
All

入选标准

  • 1.Patients or family gave written informed consents to participant in this study
  • 2.Patients with first episode hemiplegia caused by primary supratentorial intracerebral hemorrhage or cerebral infarction
  • 3.Patient meet the following criteria at the initial assessment:
  • •Within 90 days after onset
  • •Aged 20-79 years
  • •Body weight is between 40-80 kg.
  • •Functional Independence Measure (FIM) walking score ≤ 3
  • •Brunnstrom stage of lower extremity ≤ 3
  • •Able to understand the meaning of the study and follow the instruction

排除标准

  • 1.History of myocardial infarction
  • 2.Symptom of angina / arrhythmia
  • 3.Symptom of respiratory disorders
  • 4.Muscular or other neurological disorders such as diabetic neuropathy
  • 5.Communicable infection
  • 6.Joint contracture / limb deformity that affects walking: range of motion of hip < 5 degree, knee extension < -5 degree, ankle dorsiflexion with knee extension position < 5 degree
  • 7.Heterotropic ossification that restrict the range of motion of joints of lower extremities
  • 8.Being vulnerable to fracture such as severe osteoporosis of spine, lower extremities
  • 9.Incontinence of urine or feces
  • 10.Poor control of hypertension: BP ≥ 180/120 mmHg
  • 11.Inadequate control of tachycardia: HR ≥ 120 bpm
  • 12.Training restriction due to reduce cardiac function or respiratory dysfunction
  • 13.Visual or auditory impairment hindering training
  • 14.Pregnant patient
  • 15.Recent participation in other clinical trials

研究者

发起方
/A

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