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Clinical Trials/NCT02993042
NCT02993042
Completed
N/A

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

Seoul National University Hospital1 site in 1 country12 target enrollmentDecember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Seoul National University Hospital
Enrollment
12
Locations
1
Primary Endpoint
Percentage of dual-task interference: cognitive
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
February 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Han Gil Seo

Clinical Assistant Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Percentage of dual-task interference: cognitive

Time Frame: at 4 weeks

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

Percentage of dual-task interference: physical

Time Frame: at 4 weeks

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

Secondary Outcomes

  • 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)

Study Sites (1)

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