About this trial
The goal of this clinical investigation is to evaluate the effectiveness of home use of a lightweight robotic lower limb exoskeleton as a walking aid device on quality of life in patients with multiple sclerosis with gait disorders.
Participants will wear an exoskeleton (Keeogo) for 8 weeks at home during the experimental phase. This phase is compared to an 8-week control phase at home with advice on regular physical activity adapted to their abilities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with multiple sclerosis according to the revised Mac Donald diagnostic criteria (2017) in the relapsing-remitting form more than 6 months from a relapsing or progressive period.
An Expanded Disability Status Scale (EDSS) between 5 and 6.5 on the EDSS scale (Kurtzke 1983)
Living at home
Using a walking aid
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
Keeogo
DeviceKeeogo is exoskeleton for walking assistance
adviced home practice
Other interventionhealth tips for regular and appropriate physical activity
Treatment groups
Trial outcomes
Primary outcomes
Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
The Functional Assessment Of Multiple Sclerosis (FAMS) is a self-administered health questionnaire related to quality of life for patients with multiple sclerosis
Secondary outcomes
Walking and balancing performance with the Keeogo exoskeleton (1)
Measured by 2 minutes walking test
Walking and balancing performance with the Keeogo exoskeleton (2)
Measured by 10 meter walking test
Walking and balancing performance with the Keeogo exoskeleton (3)
Measured by the Timed up and go Test
Walking and balancing performance with the Keeogo exoskeleton (4)
Measured by Functional Stair Test (FST)
Sponsors and contacts
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