Actively Recruiting
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.
Led by Pôle Saint Hélier · Updated on 2025-04-09
28
Participants Needed
6
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple sclerosis in the relapsing-remitting form for more than 6 months
- Expanded Disability Status Scale (EDSS) score between 5 and 6.5
- Living at home
- Using a walking aid
- 18 years old or older
- Freely consent to participate
- Height more than 1.52 meters
- Hip Manual Muscle Testing score 3+ or higher (flexors and expanders)
- Knee Manual Muscle Testing score 2 or higher (flexors and expanders)
- Berg Balance Scale score greater than 20
- Affiliated with or beneficiary of a social security plan
You will not qualify if you...
- Impaired comprehension preventing study completion
- Unable to walk without assistance for 10 minutes
- Scheduled rehabilitation stay during follow-up
- Psychiatric conditions affecting withdrawal experience
- Severe cognitive impairment (MMSE less than 24)
- Person deprived of liberty by judicial or administrative decision
- Under psychiatric care or admitted to institution not for research
- Spasticity greater than 3 on Held and Tardieu scale in relevant muscles
- Complete paralysis of lower limbs
- Severe osteoporosis
- Hip or knee replacements limiting walking or sitting
- Severe vascular disorders of lower limbs
- Existing wounds or skin lesions where device is worn
- Pregnant or postpartum without lumbopelvic recovery
- Orthopedic disorders preventing device adjustment
- Uncontrolled epilepsy or tremors
- Uncontrolled autonomic dysreflexia
- Severe balance or neurological disorders preventing safe device use
- Conditions preventing safe moderate-intensity exercise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hospices Civils de Lyon - Hôpital Henry Gabrielle
Saint-Genis-Laval, Auvergne-Rhône-Alpes, France, 69230
Actively Recruiting
2
Pôle Saint Hélier
Rennes, Brittany Region, France, 35000
Actively Recruiting
3
Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille
Lomme, Hauts-de-France, France, 59160
Actively Recruiting
4
Centre de rééducation Fonctionnelle Propara-Montpellier
Montpellier, Occitanie, France, 34090
Actively Recruiting
5
CHU Angers- SSR Les Capucins
Angers, Pays de la Loire Region, France, 49103
Actively Recruiting
6
CHU Nantes site de Saint Jacques
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
Research Team
P
Phillipe Gallien, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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