Abstract
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).
Highlights
Multiple sclerosis (MS) is a patchy, inflammatory, autoimmune, and demyelination disorder of the central nervous system characterized by the accumulation of progressive neurological impairment [1]
Increasing evidence suggests that impaired mobility and symptoms such as fatigue are important factors contributing to the observed reduction in quality of life [7] and, in some cases, increased costs [8] associated with MS
To the knowledge of the authors, the current trial is the first analyzing the effects of an Overground robotic (OR) intervention for gait training in people affected by MS
Summary
Multiple sclerosis (MS) is a patchy, inflammatory, autoimmune, and demyelination disorder of the central nervous system characterized by the accumulation of progressive neurological impairment [1]. MS presents with a wide range of neurological symptoms related to the varying degree and location of axonal and neuronal damage. Reduced mobility and gait dysfunction are the most noticeable signs of MS; up to 85% of people with MS report difficulty in walking [2, 3] after 10 years of disease onset. Over 60% of people with MS experience some degree of cognitive impairment [4] that correlates with peripheral changes in pro-inflammatory cytokines such as interleukin 1β (IL-1β) and tumor necrosis factor α [5]. Increasing evidence suggests that impaired mobility and symptoms such as fatigue are important factors contributing to the observed reduction in quality of life [7] and, in some cases, increased costs [8] associated with MS. From mid-life and on, MS disease progression can negatively impact employment and participation in everyday activities [9]
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