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RECRUITINGINTERVENTIONAL

Robotic Gait Rehabilitation in Parkinson's Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - • 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * • 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)

Treatments Being Tested

DEVICE

G-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.

OTHER

Conventional 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