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

NCT ID: NCT02993042

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-02-28

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot-assisted gait training

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

Group Type: EXPERIMENTAL

Robot-assisted gait training

Intervention Type: DEVICE

Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.5km / h (0.42m / s) and can be increased gradually to 3.0km / h (0.83m / s) by increasing to 0.2km / h (0.06m / s) per session. The therapist provides appropriate visual and auditory instructions to allow the patient to participate as fully as possible in the walking cycle provided by the walking robot. The treatment time per session is 30 minutes except for the time of wearing and releasing.

Interventions

Robot-assisted gait training

Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.5km / h (0.42m / s) and can be increased gradually to 3.0km / h (0.83m / s) by increasing to 0.2km / h (0.06m / s) per session. The therapist provides appropriate visual and auditory instructions to allow the patient to participate as fully as possible in the walking cycle provided by the walking robot. The treatment time per session is 30 minutes except for the time of wearing and releasing.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Gil Seo

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RAGT-GAP

Identifier Type: -

Identifier Source: org_study_id