Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.
Recruiting · NCT05835622 · Interventional (participants receive a specific treatment) · Lead sponsor: Pôle Saint Hélier
View the official record on ClinicalTrials.gov →Interventions studied
Keeogoadviced home practice
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Non-Inclusion Criteria:
- 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
Where it is running
6 locations listed.
- Hospices Civils de Lyon - Hôpital Henry Gabrielle - Saint-Genis-Laval, Auvergne-Rhône-Alpes, France
- Pôle Saint Hélier - Rennes, Brittany Region, France
- Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille - Lomme, Hauts-de-France, France
- Centre de rééducation Fonctionnelle Propara-Montpellier - Montpellier, Occitanie, France
- CHU Angers- SSR Les Capucins - Angers, Pays de la Loire Region, France
- CHU Nantes site de Saint Jacques - Nantes, Pays de la Loire Region, France