Overground Robotic Program Preserves Gait in Individuals With Multiple Sclerosis and Moderate to Severe Impairments: A Randomized Controlled Trial.

Objective: To determine how overground robotic (OR) training added to ongoing rehabilitation affects gait speed, lower extremity function, functional mobility, and fatigue in individuals with multiple sclerosis (MS) and moderate to severe gait impairments.

Design: Randomized controlled trial.

Setting: Outpatient setting at the Multiple Sclerosis Association of Bizkaia, an association serving MS patients in Bizkaia, Spain.

Participants: Individuals with MS (N=36) participated in this interventional study. Inclusion criteria were age of 18 years or older, Expanded Disability Status Scale score between 4.5 and 7, and the need for assistive devices for walking outdoors.

Interventions: The control group (CG) engaged in an ongoing rehabilitation program consisting of weekly 1-hour individualized sessions. The intervention group (OR group) also participated in this program in addition to a twice-weekly individualized and progressive OR gait training intervention for 3 months, aiming to reach a maximum of 40 minutes by the end of the 3-month period.

Main Outcome Measures: Primary outcome was the 10-meter walking test (10MWT). Secondary variables included the Short Physical Performance Battery, the timed Up and Go (TUG) test, and the Modified Fatigue Impact Scale.

Results: The OR group maintained 10MWT performance and significantly improved on the TUG test (P=.049, medium effect size) without increasing fatigue perception. The CG demonstrated a decline on the 10MWT (P=.044, small effect size) and reduced fatigue (P=.024, medium effect size). No time per group interaction was observed for any variable.

Conclusion: The evaluated intervention could preserve gait speed and significantly improve functional mobility without increasing perceived fatigue in participants. Thus, OR exoskeletons could be considered a tool to deliver intensive practice of good-quality gait training in individuals with MS and moderate to severe gait impairments. Further studies are necessary to confirm these preliminary results.