RecruitingNot ApplicableNCT05218187

Robotic Gait Rehabilitation in Parkinson's Disease


Sponsor

Indiana University

Enrollment

30 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes. Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability. Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System. Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, function, and quality of life


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Age \> 18years
  • Confirmed diagnosis of Parkinson's Disease
  • Hoehn and Yahr stage 1 to 3
  • Stable course of disease-modifying therapy over the past 3 months
  • Mini Mental State Examination \> 24
  • Physician approval for exercise
  • Stable deep brain stimulation setting for the past year
  • Demonstrate a need for functional rehabilitation

Exclusion Criteria7

  • • Severe dyskinesia or severe on-off phenomenon
  • Unstable medication regiment
  • Any co-morbidity that will interfere with walking
  • Conventional physical therapy or G-EO training within the past 6 months
  • Height \<1m or \>2m
  • Body weight \>150 kg
  • Contraindications to G-EO gait training (e.g., bone instability)

Interventions

DEVICEG-EO End-Effector Gait Trainer

The G-EO Gait Trainer uses distal fixation to promote a gait recovery by facilitating a controlled walking environment that includes an over-ground pattern and stair climbing. In addition, the device provides body position control to enable the patient to concentrate on the cyclical motion of walking without the fear of falling. Physical therapists can control different parameters of the gait cycle through computerized adjustments and the training setting can be manipulated to engage patients in active participation.

OTHERConventional Physical Therapy Treatment

Therapists will use traditional methods of neurological rehabilitation for improved gait and balance. These approaches will include stretching, strengthening, therapeutic exercises, balance training, and over-ground walking


Locations(1)

IU Health Neurorehabilitation and Robotics

Indianapolis, Indiana, United States

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NCT05218187


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