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

Recruiting now · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT05835622

Run by

Pôle Saint Hélier

People needed

28

Starts

2024-02-01

Expected to finish

2026-10-02

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 18 years old or older
• Have freely consented to participate in this study
• To be more than 1m52 tall
• Hip Manual Muscle Testing (MMT) score ≥ 3+ (flexors and expanders)
• Knee Manual Muscle Testing (MMT) score ≥ 2 (flexors and expanders)
• Berg scale (BBS) score > 20
• Patient affiliated with a social security plan or beneficiary of such a plan.
• Non-Inclusion Criteria:
• Impaired comprehension preventing completion of the protocol
• Inability to walk without assistance for 10 minutes
• Have a rehabilitation stay scheduled during the follow-up period of the clinical investigation
• Diagnosed psychiatric conditions that may have an impact on the experience of withdrawal of technical assistance at the end of the protocol
• Severe cognitive impairment (MMSE<24)
• Person deprived of liberty by a judicial or administrative decision
• A person under psychiatric care or admitted to a health or social institution for purposes other than research.
• Spasticity >3 on the Held and Tardieu scale affecting the hamstring, quadriceps, adductor or sural triceps muscles
• Complete paralysis of the lower limbs
• Severe osteoporosis
• Hip and/or knee replacements that would sufficiently limit range of motion for walking and sitting or squatting
• Severe vascular disorders of the lower limbs
• Existing wounds or skin lesions where the device is worn

Where it is running

• Hospices Civils de Lyon - Hôpital Henry Gabrielle — Saint-Genis-Laval, Auvergne-Rhône-Alpes, France (enrolling)
• Pôle Saint Hélier — Rennes, Brittany Region, France (enrolling)
• Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille — Lomme, Hauts-de-France, France (enrolling)
• Centre de rééducation Fonctionnelle Propara-Montpellier — Montpellier, Occitanie, France (enrolling)
• CHU Angers- SSR Les Capucins — Angers, Pays de la Loire Region, France (enrolling)
• CHU Nantes site de Saint Jacques — Nantes, Pays de la Loire Region, France (enrolling)

Full record on ClinicalTrials.gov

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