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.

An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial.

Maintaining the ability to walk is one of the significant challenges in people with multiple sclerosis (MS) for keeping a good quality of life as the disease and the aging process progresses. Overground robotic (OR) wearable exoskeletons are promising tools for gait rehabilitation, but currently there is no evidence of their clinical effects on patients with MS. The present study aims to determine the effects of an OR intervention in people with MS and moderate to severe walking disabilities and ascertain if benefits are maintained over a follow-up period of 3 months. This randomized controlled trial will include 36 participants with MS. Inclusion criteria are: older than 18 years, definitive diagnosis of MS, 4.5-7 points on the EDSS (Expanded Disability Status Scale), and needing one or two canes or crutches for walking outdoors. Subjects in the control group will receive conventional physiotherapy sessions at ADEMBI (Asociación de Esclerosis Múltiple de Bizkaia) provided to control spasticity, maintain articular range and exercise balance. Subjects in the intervention group will receive the same physiotherapy but also participate in a progressive OR gait training program assisted by the EksoTM exoskeleton. The program consists of twice a week individually supervised sessions in two setting modalities: PreGait and ProStepPlus. The training parameters (duration, speed, cadence, length of steps) will be set during the first session and the progression and intensity of the intervention will be adapted to the tolerance of each participant. The primary outcome of this study is gait speed. Secondary outcomes will include physical and cognitive performance tests, clinical, fatigue and quality of life assessments, and changes in the plasma levels of inflammatory cytokines. The present trial is the first analyzing the effectiveness of an OR intervention for gait training in patients with MS. It will help clarify the applicability of robotic technologies to clinical practice, extending the functionality and quality of life of people with MS to face a successful aging process. (ACTRN12619000014156; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376548).