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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Angers- SSR Les Capucins
RECRUITING
Angers
Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille
RECRUITING
Lomme
Centre de rééducation Fonctionnelle Propara-Montpellier
RECRUITING
Montpellier
CHU Nantes site de Saint Jacques
RECRUITING
Nantes
Pôle Saint Hélier
RECRUITING
Rennes
Hospices Civils de Lyon - Hôpital Henry Gabrielle
RECRUITING
Saint-genis-laval
Contact Information
Primary
Phillipe Gallien, Doctor
philippe.gallien@pole-sthelier.com
0299295099
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-10-02
Participants
Target number of participants: 28
Treatments
Other: Arm A
8 weeks of using keeogo at home (experimental phase) followed by 8 weeks of wash-up and then followed by 8 weeks of recommended home practise (control phase).
Other: Arm B
8 weeks of recommended home practise (control phase) followed by 8 weeks of wash-up and then followed by 8 weeks of using keeogo at home (experimental phase)
Related Therapeutic Areas
Sponsors
Leads: Pôle Saint Hélier

This content was sourced from clinicaltrials.gov