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Completed NCT05835622

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

Conditions: Multiple Sclerosis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 28
Sponsor: Pôle Saint Hélier

Location: Hospices Civils de Lyon - Hôpital Henry Gabrielle Saint-Genis-Laval Auvergne-Rhône-Alpes

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 Criteria

Inclusion Criteria: * 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\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 * Pregnant woman or postpartum woman who has not completed lumbopelvic recovery * Orthopedic disorders of the lower limb that may prevent satisfactory adjustment of Keeogo * Uncontrolled epilepsy or tremors * Uncontrolled autonomic dysreflexia * Severe balance disorders, neurological disorders (any condition that prevents the safe control of balance and/or movement of the limbs at all times while wearing the Keeogo System) * Conditions that prevent safe moderate-intensity exercise

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05835622). StuddyBuddy aggregates publicly available trial information.