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

March 8, 2018 updated by: Han Gil Seo, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Robot-assisted gait training
Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&S Mechanics Co. Ltd., Seoul, Korea)
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 4 weeks
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
at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 meter walk test (sec): single, cognitive dual-task, physical dual-task
Time Frame: baseline, at 4 weeks, at 8 weeks
baseline, at 4 weeks, at 8 weeks
Berg balance scale
Time Frame: baseline, at 4 weeks, at 8 weeks
baseline, at 4 weeks, at 8 weeks
Korean version of the Falls Efficacy Scale-International
Time Frame: baseline, at 4 weeks, at 8 weeks
baseline, at 4 weeks, at 8 weeks
Step length
Time Frame: baseline, at 4 weeks, at 8 weeks
Gait analysis using IMU sensors
baseline, at 4 weeks, at 8 weeks
Step width
Time Frame: baseline, at 4 weeks, at 8 weeks
Gait analysis using IMU sensors
baseline, at 4 weeks, at 8 weeks
Cadence
Time Frame: baseline, at 4 weeks, at 8 weeks
Gait analysis using IMU sensors
baseline, at 4 weeks, at 8 weeks
Vertical displacement
Time Frame: baseline, at 4 weeks, at 8 weeks
Gait analysis using IMU sensors
baseline, at 4 weeks, at 8 weeks
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
baseline, at 8 weeks
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
baseline, at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAGT-GAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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