RecruitingNot ApplicableNCT05835622

Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.

Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.


Sponsor

Pôle Saint Hélier

Enrollment

28 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable walking exoskeleton (a robotic suit worn on the legs that assists with walking) can improve quality of life for people with relapsing-remitting multiple sclerosis (MS) who have moderate walking difficulties. Participants will use the device at home and be followed up over time. **You may be eligible if...** - You have relapsing-remitting MS confirmed by standard diagnostic criteria - Your disability score is between 5 and 6.5 on the standard MS scale (meaning you need a walking aid but can still walk with help) - You are at least 18 years old and at least 152 cm tall - You live at home and use a walking aid - You have adequate leg strength to use the device safely **You may NOT be eligible if...** - You have severe spasticity (muscle stiffness) in the legs, complete leg paralysis, or severe osteoporosis - You have hip or knee replacements that severely limit movement - You have uncontrolled epilepsy or tremors - You are pregnant or in early recovery after childbirth - You have severe cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEKeeogo

Keeogo is exoskeleton for walking assistance

OTHERadviced home practice

health tips for regular and appropriate physical activity


Locations(6)

Hospices Civils de Lyon - Hôpital Henry Gabrielle

Saint-Genis-Laval, Auvergne-Rhône-Alpes, France

Pôle Saint Hélier

Rennes, Brittany Region, France

Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Hauts-de-France, France

Centre de rééducation Fonctionnelle Propara-Montpellier

Montpellier, Occitanie, France

CHU Angers- SSR Les Capucins

Angers, Pays de la Loire Region, France

CHU Nantes site de Saint Jacques

Nantes, Pays de la Loire Region, France

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NCT05835622


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