None listed
Conditions
Brief summary
The major aim of this study is to ascertain if a supervised training program through the wearable exoskeleton “Ekso Bionics” in persons with MS carried out in ADEMBI, improves gait speed, functional capacity, cognitive capacity and quality of life, and modifies inflammatory biomarkers when compared with a control group that receives usual care. The present study is based on a previous pilot study in which we successfully collected preliminary data to accurately demonstrate the feasibility of recruitment, estimate the required sample size for the current trial, confirm the adherence and safety of the intervention, refine the outcome assessments, and optimize the organizational infrastructure.
Interventions
Maintaining the ability to walk is one of the significant challenges in persons with multiple sclerosis (MS) for keeping an active life style with a good quality. This randomized clinical trial aims to evaluate the effectiveness of a 3 month training program through a wearable exoskeleton in persons with multiple sclerosis (MS) on gait velocity. Subjects in the intervention group will add to the physiotherapy habitual treatment scheduled for the control group, the participation in a progressive
Maintaining the ability to walk is one of the significant challenges in persons with multiple sclerosis (MS) for keeping an active life style with a good quality. This randomized clinical trial aims to evaluate the effectiveness of a 3 month training program through a wearable exoskeleton in persons with multiple sclerosis (MS) on gait velocity. Subjects in the intervention group will add to the physiotherapy habitual treatment scheduled for the control group, the participation in a progressive gait training program assisted by the exoskeleton “Ekso Bionics” (Europe GmbH, Tullastrasse 80, 79108 Friburgo, Alemania, CE 852.170501, Notified Body & ID: UL, 0843). Ekso® is a powered, wearable robotic lower limb exoskeleton with actuated hips and knees that provides assistance to lower limb segments during movement, dependent on user needs. The programme´s technical content is based on a specific literature review including author´s expertise and field experience. The intervention will consist of twice a week individually supervised sessions assisted by the wearable exoskeleton. The approximate duration of each training session will range between 20-30 minutes. An interval of at least 48 hours between training sessions will be respected. The sessions will include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit exercises. The progression and intensity of the intervention will be adapted to the capacity of each participant (duration, speed, cadence, length of the steps, robotic assistance, etc.) and the total duration of the training will be progressively increased as the participants increase their tolerance. Goals will be adapted in response to illness, injury or physical symptoms. Subjects will wear their own shoes, orthotics and usual technical aids. Training attendance will be recorded every session. The program will be carried out by experienced physiotherapists trained in exoeskeleton driving in ADEMBI (Asociación de Esclerosis Múltiple de Bizkaia: http://www.esclerosismultipleeuskadi.org/adembi/), the association of persons with multiple sclerosis of our territory.
Sponsors
Ana Rodriguez Larrad
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be considered eligible for the study if all of the following apply: aged greater than or equal to 18 years, diagnosis of primary or secondary progressive MS according to the McDonald criteria, scored on the Expanded Disability Status Scale between 1.5 and 7, scored on the Mini Mental State Examination test greater than or equal to 20 points.
Exclusion criteria
Participants will not be eligible for the study if they have another neurological pathology in addition to MS, have any musculoskeletal disorder that may limit the extension of the hip and knee or plantar flexion of the ankle, have suffered an outbreak of MS during the 3 months prior to the start of the study, not stable pharmacological treatment or that foresees its modification during the study, treatment with botulinum toxin in the 12 weeks prior to the beginning of the study.
Outcome results
None listed