Evaluating Home Use of the Keeogo Walking Exoskeleton to Improve Quality of Life in Adults with Multiple Sclerosis and Gait Problems

What this Trial Is About

Researchers are evaluating the impact of using a lightweight robotic lower limb exoskeleton called Keeogo on the quality of life of patients with multiple sclerosis who have walking difficulties. This study includes patients with a specific level of disability who live at home and use walking aids. The trial is designed as a multicenter, controlled, randomized, cross-over, open-label clinical investigation to compare the effects of the exoskeleton use with regular physical activity advice. Participants are assigned randomly to one of two groups one group uses the Keeogo exoskeleton at home for eight weeks after a five-day training program to learn how to use the device, followed by an eight-week wash-out period and then an eight-week control phase with recommended physical activity. The other group starts with the control phase, then the wash-out period, and finally the experimental phase using Keeogo. After both phases, there is a three-month follow-up period. During the study, participants will be assessed multiple times to measure changes in quality of life using a specific questionnaire for multiple sclerosis, walking and balance performance with and without the exoskeleton, muscle spasticity, fatigue, anxiety, depression, and daily walking distance. Satisfaction with the device and sense of self-efficacy will also be evaluated. Assessments occur at screening, after each phase, and during follow-up visits to monitor participant progress and safety over the study duration.

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