NCT05835622

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Pôle Saint Hélier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It is a multicenter, controlled, randomized, cross-over, open-label clinical investigation. Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) between 5 and 6.5,living at home and using an assistive device for walking will be included. After enrollment, patients will be randomised in one of the 2 study-arm. * Arm A: experimental phase / Wash-Out (WO) (8 weeks) / control phase * Arm B: control phase / WO (8 weeks) / experimental phase During the experimental phase, patients will receive a Keeogo specific training for five days. The purpose of this training programme is to ensure familiarity and acceptance of the device. Then, the patients will take Keeogo home and will have to use the device as much as possible indoors and outdoors for seven weeks. During the control phase, patients will be at home for eight weeks with advice on regular physical activity adapted to their abilities. After the second phase, all patients will have a 3 months of follow-up.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Keeogo	Keeogo is exoskeleton for walking assistance
OTHER	adviced home practice	health tips for regular and appropriate physical activity

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-10-01
• Completion: 2026-10-02
• First posted: 2023-04-28
• Last updated: 2025-04-09

Locations

6 sites across 1 country: France