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临床试验/NCT03565185
NCT03565185已完成不适用

Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke

Erenköy Physical Therapy and Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
6 minute walk test

研究概览

简要总结

Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)

详细描述

There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rehabilitation need for stroke
  • Patients under FAC stage 4
  • No contraindications for robotic rehabilitation
  • Subacute stroke

排除标准

  • The robot-orthosis does not fit the patient's body
  • Inadequate body weight (obesity)
  • Severe contractures
  • Bone instability (nonstable spinal cord fracture and severe osteoporosis)
  • Circulation problems
  • Cardiac problems
  • Open wounds on the lower extremities or in the body where they will come into contact with the orthosis
  • Uncoordinated, psychotic or aggressive patients
  • Serious cognitive disorders
  • Patients with long-term infusion therapy
  • Hip, knee, ankle arthrodesis
  • Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia
  • Those with severe vascular problems of the lower extremity
  • Conditions requiring rest or immobilization, such as osteomyelitis and other inflammatory/infectious diseases
  • Severe respiratory diseases

结局指标

主要结局

6 minute walk test

时间窗: 4 weeks

6 minute walk test for walking speed

10 meter walking test

时间窗: 4 weeks

10 meter walking test for walking

Postural Assessment Scale for Stroke(PASS)

时间窗: 4 weeks

Postural Assessment Scale for Stroke(PASS) will be used

次要结局

  • FAC(Functional Ambulation Classification)(4 weeks)
  • Barthel Index(4 weeks)

研究者

发起方
Erenköy Physical Therapy and Rehabilitation Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

AYLİN SARI

Medical Doctor,

Erenköy Physical Therapy and Rehabilitation Hospital

研究点 (2)

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