Multiple Sclerosis Clinical Trial

G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

Summary

The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as a potentially potent rehabilitation tool for restoring and maintaining function in progressive Multiple Sclerosis (MS). This approach represents a paradigm shifting opportunity for improving current clinical practices for patients with progressive MS. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach.

There are several novel aspects of the proposed trial: (1) the examination of a novel gait rehabilitation stimulus (G-EO System) that could alter current clinical practices; (2) the focus on patients with progressive MS who have gait impairment (i.e., those who have received minimal research attention), which was recently described as the greatest therapeutic challenge facing the MS community; and (3) a study design that accounts for standard therapy.

Specific Aims: The investigators designed a single-blinded, randomized pilot trial of electromechanically-assisted gait training using the G-EO System in patients with progressive MS with gait disability (EDSS=4.0-7.5).

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, symptomatic, quality of life, and participatory outcomes.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

18-64 years
Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician)
EDSS 4.0-7.522
Stable course of disease-modifying therapy over the past 6 months
Asymptomatic (i.e., no underlying cardiovascular disease)
Physician approval for exercise
Willingness to visit the IU Health Neurosciences Center for testing and training

Exclusion Criteria:

Pregnancy
Current use of dalfampridine (Ampyra®)
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)

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

15

Study ID:

NCT03980145

Recruitment Status:

Completed

Sponsor:

Indiana University

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There is 1 Location for this study

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Neurorehabilitation and Robotics at IU Health Neuroscience Center
Indianapolis Indiana, 46202, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

15

Study ID:

NCT03980145

Recruitment Status:

Completed

Sponsor:


Indiana University

How clear is this clinincal trial information?

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