Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial

Min-Gu Kang, Seo Jung Yun, Hyun Iee Shin, Eunkyung Kim, Hyun Haeng Lee, Byung-Mo Oh, Han Gil Seo, Min-Gu Kang, Seo Jung Yun, Hyun Iee Shin, Eunkyung Kim, Hyun Haeng Lee, Byung-Mo Oh, Han Gil Seo

Abstract

Background: Robot-assisted gait training (RAGT) was developed to restore gait function by promoting neuroplasticity through repetitive locomotor training and has been utilized in gait training. However, contradictory outcomes of RAGT have been reported for patients with Parkinson's disease (PD). In addition, the mechanism of the RAGT treatment effect is still unknown. This study aims to investigate the effects of RAGT on gait velocity in patients with PD and to unveil the mechanisms of these effects.

Methods: This is a prospective, single-blind, single-center, randomized controlled trial. Eligible participants will be randomly allocated to: 1) a Walkbot-S™ RAGT group or 2) a treadmill training group. The participants will receive three 45-min sessions of each intervention per week for 4 weeks. Gait speed during RAGT will be targeted to the maximal speed depending on the participant's height; the same principle will be applied to the treadmill training group to match the training intensity. The primary outcome measure is gait speed measured by the 10-Meter Walk Test at a comfortable pace under single-task conditions. Secondary outcomes include dual-task interference, the Berg Balance Scale, Timed Up and Go test, the Korean version of the Falls Efficacy Scale-International, New Freezing of Gait Questionnaire, Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, and functional connectivity measured by resting-state functional magnetic resonance imaging. Baseline assessments (T0) will be conducted to acquire clinical characteristics and outcome measure values before the intervention. Postintervention assessments (T1) will compare immediate efficacies within 3 days after the intervention. Follow-up assessments (T2) will be conducted 1 month after the intervention. Considering an alpha of 0.05 and a power of 80%, the total number of participants to be recruited is 44.

Discussion: This study will reveal the effect of RAGT using an exoskeletal robot, not only on gait speed, but also on gait automaticity, balance function, fall risk, quality of life, and disease severity. In addition, the study will shed new light on the mechanism of the RAGT effect by evaluating changes in gait automaticity and brain functional networks.

Trial registration: ClinicalTrials.gov, NCT03490578 . Registered on 21 March 2018.

Keywords: Exoskeleton device; Gait; Neuroimaging; Parkinson disease; Rehabilitation.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the Institutional Review Board of the Seoul National University Hospital (H-1802-056-921) and by the Korean Ministry of Food and Drug Safety (approval no. 849). Any changes to the protocol will be reported to the committees and approved. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT; Additional file 1). Informed consents will be obtained from all participants by the clinical research coordinator and principal investigator.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram
Fig. 2
Fig. 2
a The Walkbot-S™, an exoskeletal-type gait training robot; b a patient participating in gait training using Walkbot-S™
Fig. 3
Fig. 3
Study schedule of enrollment, interventions, and assessments. 10MWT 10-m walk test, BBS Berg Balance Scale, KFES-I Korean version of the Falls Efficacy Scale-International, MDS-UPDRS Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale, NFOG-Q New Freezing of Gait Questionnaire, RAGT robot-assisted gait training, rs-fMRI resting-state functional magnetic resonance imaging, TUG Timed Up and Go

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