Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Percentage of dual-task interference: cognitive
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Robot-assisted gait training
Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&S Mechanics Co. Ltd., Seoul, Korea)
Intervention: Robot-assisted gait training (Device)
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
- Berg balance scale(baseline, at 4 weeks, at 8 weeks)
- 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)
- Step length(baseline, at 4 weeks, at 8 weeks)
- Step width(baseline, at 4 weeks, at 8 weeks)
Investigators
Han Gil Seo
Clinical Assistant Professor
Seoul National University Hospital