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

NCT02993042 | Completed

• 1 other identifier: RAGT-GAP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

Rehabilitation; Robot-assisted gait training

Outcome Measures

Primary Outcomes (2)

• Percentage of dual-task interference: cognitive

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

  at 4 weeks

• Percentage of dual-task interference: physical

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

  at 4 weeks

Secondary Outcomes (9)

• 10 meter walk test (sec): single, cognitive dual-task, physical dual-task

  baseline, at 4 weeks, at 8 weeks

• Berg balance scale

  baseline, at 4 weeks, at 8 weeks

• Korean version of the Falls Efficacy Scale-International

  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 Arms (1)

Robot-assisted gait training

EXPERIMENTAL

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

Device: Robot-assisted gait training

Interventions

Robot-assisted gait training 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.

Robot-assisted gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

KR (1)