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

NCT05835622

RecruitingNA

Sponsor: Pôle Saint Hélier

Conditions: Multiple Sclerosis

Interventions: Keeogo, adviced home practice

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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\<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
* 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

Locations (6)

Saint-Genis-Laval, Auvergne-Rhône-Alpes, France
Rennes, Brittany Region, France
Lomme, Hauts-de-France, France
Montpellier, Occitanie, France
Angers, Pays de la Loire Region, France
Nantes, Pays de la Loire Region, France