Clinical Trial: Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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 autonom
Sponsor: Seoul National University Hospital

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 10 meter walk test (sec): single, cognitive dual-task, physical dual-task [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
• Berg balance scale [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
• Korean version of the Falls Efficacy Scale-International [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
• Step length [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  Gait analysis using IMU sensors
• Step width [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  Gait analysis using IMU sensors
• Cadence [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  Gait analysis using IMU sensors
• Vertical displacement [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  Gait analysis using IMU sensors
• Percentage of dual-task interference: cognitive [ Time Frame: baseline, at 8 weeks ]
  (Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
• Percentage of dual-task interference: physical [ Time Frame: baseline, at 8 weeks ]
  (Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test

Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: December 6, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: December 12, 2016
Last Verified: December 2016