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
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