Robot-assisted Gait Training in Patients With Parkinson's Disease

December 2, 2019 updated by: Han Gil Seo, Seoul National University Hospital

Effect of Robot-assisted Gait Training in Patients With Parkinson's Disease: a Randomized Controlled Trial

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 randomized controlled trial to investigate the effect of robot-assisted gait training on walking ability and functional connectivity of brain in patients with Parkinson's disease using an exo-skeletal robot.

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.

Patients with Parkinson's disease are known to exhibit changes in functional connectivity of the brain from an early stage. In addition, a number of studies have reported that patients with Parkinson's disease with gait freezing have a change in resting brain activity and functional connectivity of the brain. However, no studies have examined the functional connectivity of the brain in patients with Parkinson's disease before and after rehabilitation.

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, and functional connectivity of the brain has not been studied. Therefore, this study is aimed to investigate the effect of robot-assisted gait training on walking ability and functional connectivity of brain in patients with Parkinson's disease using an exo-skeletal robot.

Study Type

Interventional

Enrollment (Actual)

44

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

14 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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 1.0 km/h and can be increased gradually to 3.0 km/h. The gait robot provides an auditory feedback according to gait cycle and a visual feedback on the patient's active participation. If the patient can tolerate, the gait robot may control the walking speed automatically according to the patient's participation. The treatment time per session is 45 minutes including don and doff time. Total 12 sessions are provided for 4 weeks.
Active Comparator: Intensive treadmill training
Intensive treadmill training using an usual treadmill
Device: Intensive treadmill training
Patients exercise on the treadmill. The initial walking speed starts at 1.0 km/h and can be increased gradually to 3.0 km/h. The therapist provides appropriate visual and auditory instructions to allow the patient to participate in the treadmill training. The treatment time per session is 45 minutes including warm-up and cool-down. Total 12 sessions are provided for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
10 meter walk test (sec) : single task
Time Frame: at 4 weeks
at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 meter walk test (sec) : single task
Time Frame: baseline, at 8 weeks
baseline, at 8 weeks
10 meter walk test (sec) : cognitive dual-task
Time Frame: baseline, at 4 weeks, at 8 weeks
baseline, at 4 weeks, at 8 weeks
10 meter walk test (sec) : 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
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function (Maximum score 56).
baseline, at 4 weeks, at 8 weeks
Timed-up & go test (sec)
Time Frame: baseline, at 4 weeks, at 8 weeks
baseline, at 4 weeks, at 8 weeks
Korean version of Falls Efficacy Scale-International
Time Frame: baseline, at 4 weeks, at 8 weeks
The FES-I is a 16-item questionnaire of fall-related self-efficacy. The 16 items of the FES-I are rated according to "how concerned you are about the possibility of falling", using the following responses (score in parentheses): not at all (1), somewhat (2), fairly (3), and very concerned (4). Thus, the total score ranges from 16 to 64 points.
baseline, at 4 weeks, at 8 weeks
New Freezing of Gait questionnaire (NFOG-Q) - Part I
Time Frame: baseline, at 4 weeks, at 8 weeks
Part I detected the presence of FOG using a dichotomous item in which individuals were classified as a freezer (FR) or a non-freezer (NFR) if they had experienced FOG-episodes during the past month.
baseline, at 4 weeks, at 8 weeks
New Freezing of Gait questionnaire (NFOG-Q) - Part II, III
Time Frame: baseline, at 4 weeks, at 8 weeks
Parts II and III were designed for FRs only, providing a total summed score between 0 and 28. Part II (items 2-6, scoring range 0-19) rated the severity of FOG based on its duration and frequency in its most common manifestation, i.e. during turning and initiation of gait. Part III rated the impact of FOG on daily life (items 7-9, scoring range 0-9). No separate on and off rating of parts II and III was considered to avoid unreliable assessment.
baseline, at 4 weeks, at 8 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part I
Time Frame: baseline, at 4 weeks, at 8 weeks
Part I - Non-motor experiences of daily living, questionnaire
baseline, at 4 weeks, at 8 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part II
Time Frame: baseline, at 4 weeks, at 8 weeks
Part II - Motor experiences of daily living, questionnaire
baseline, at 4 weeks, at 8 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part III
Time Frame: baseline, at 4 weeks, at 8 weeks
Part III - Motor examination, structured physical examination
baseline, at 4 weeks, at 8 weeks
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part IV
Time Frame: baseline, at 4 weeks, at 8 weeks
Part IV - Motor complications, questionnaire
baseline, at 4 weeks, at 8 weeks
Functional connectivity in resting-state fMRI (Correlation coefficient)
Time Frame: baseline, at 4 weeks
  • Correlation coefficient between BOLD signals in motor network
  • At least 6 minutes resting state fMRI imaging is desirable for acquiring stable resting state brain imaging data. The investigators divide the entire brain into voxels, and if the investigators assume TR=3sec, one voxel has 120 time series data. This data reflects the blood-oxygenation level dependent (BOLD) signal, which is related to neural activity via a complex interplay of cerebral blood flow, blood volume, and metabolic rate of oxygen.
baseline, at 4 weeks

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

National Rehabilitation Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 23, 2018

Primary Completion (Actual)

November 14, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (Actual)

April 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAGT-PD1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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