G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

Indiana University

Status: Completed

Conditions: Progressive Multiple Sclerosis

Treatments: Device: G-EO System (Reha Technology AG: Olten, Switzerland); Other: Conventional Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03980145

1701909134

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Conventional Physical Therapy

Active Comparator group

Description:

Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.

Treatment:

Other: Conventional Physical Therapy

End-Effector Robotic Training

Experimental group

Description:

G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.

Treatment:

Device: G-EO System (Reha Technology AG: Olten, Switzerland)