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

Multiple Sclerosis

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

Inclusion Criteria30

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
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.
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