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

Plain Language Summary

Simplified for easier understanding

This study is testing robotic gait training — using an exoskeleton-type device to guide and support walking — for people with Parkinson's disease. The goal is to see whether this technology can improve walking ability and movement in people with mild to moderate Parkinson's. **You may be eligible if...** - You are over 18 years old - You have a confirmed diagnosis of Parkinson's disease - Your disease is in stages 1–3 on the Hoehn and Yahr scale (mild to moderate) - Your medications have been stable for the past 3 months - You have normal cognitive function (Mini Mental State Examination score above 24) - You have received physician approval to exercise - You have a demonstrated need for rehabilitation **You may NOT be eligible if...** - You have severe uncontrollable movements (dyskinesia or severe on-off fluctuations) - You have a condition that prevents you from walking - You have received physical therapy or this type of robotic gait training in the past 6 months - You are taller than 2 meters or shorter than 1 meter, or weigh over 150 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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