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临床试验/NCT02993042
NCT02993042已完成不适用

Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Percentage of dual-task interference: cognitive

研究概览

简要总结

Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by repeating a normal gait pattern with high intensity. This study is a feasibility study to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson 's disease.

详细描述

Parkinson's disease is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.

Robot-assisted gait training is a method of rehabilitation that repeats normal gait patterns at high intensity. Recent meta-analysis has shown that robot-assisted gait training improved the recovery of independent gait after stroke compared with conventional rehabilitation therapy. On the other hand, robot-assisted gait training in Parkinson's disease has been reported to improve walking speed and walking endurance compared to conventional physical therapy, but is not superior to treadmill exercise of the same intensity. In addition, it has been reported that in patients with Parkinson's disease with balance impairment, robot-assisted gait training can improve balance disorder compared with physical therapy, and gait freezing has improved in some small-scale patients. However, studies on the effectiveness of robot-assisted gait training in Parkinson's disease are still lacking, and the mechanism of the effect has not been elucidated. In particular, the effect on gait automaticity, which is a characteristic of Parkinson 's disease, has not been studied. Therefore, this pilot study is aimed to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson's disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Clinically confirmed patients with idiopathic Parkinson's disease
  • Hoehn & Yahr stage 2.5 or 3 patients
  • Patients with a Mini-Mental Status Examination (MMSE) score of 24 or higher

排除标准

  • Patients with severe dyskinesia or on-off fluctuations due to medication
  • Patients who need to change drugs during the study period
  • Patients with sensory abnormalities of the lower limb
  • Patients with vestibular disease or paroxismal vertigo
  • Patients with other neurological or orthopedic disease involving legs, or severe cardiovascular diseases

研究组 & 干预措施

Robot-assisted gait training

Experimental

Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&S Mechanics Co. Ltd., Seoul, Korea)

干预措施: Robot-assisted gait training (Device)

结局指标

主要结局

Percentage of dual-task interference: cognitive

时间窗: at 4 weeks

(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test

Percentage of dual-task interference: physical

时间窗: at 4 weeks

(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test

次要结局

  • Vertical displacement(baseline, at 4 weeks, at 8 weeks)
  • Percentage of dual-task interference: cognitive(baseline, at 8 weeks)
  • 10 meter walk test (sec): single, cognitive dual-task, physical dual-task(baseline, at 4 weeks, at 8 weeks)
  • Korean version of the Falls Efficacy Scale-International(baseline, at 4 weeks, at 8 weeks)
  • Cadence(baseline, at 4 weeks, at 8 weeks)
  • Percentage of dual-task interference: physical(baseline, at 8 weeks)
  • Berg balance scale(baseline, at 4 weeks, at 8 weeks)
  • Step length(baseline, at 4 weeks, at 8 weeks)
  • Step width(baseline, at 4 weeks, at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Han Gil Seo

Clinical Assistant Professor

Seoul National University Hospital

研究点 (2)

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