Using a home walking exoskeleton to improve quality of life for 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.
This study is testing whether a lightweight robotic walking aid can help people with multiple sclerosis improve their quality of life when used at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pôle Saint Hélier Academic / other |
| Locations | 6 sites (Saint-Genis-Laval, Auvergne-Rhône-Alpes and 5 other locations) |
| Trial ID | NCT05835622 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the effectiveness of a lightweight robotic lower limb exoskeleton, called Keeogo, as a walking aid for patients with multiple sclerosis who experience gait disorders. Participants will use the exoskeleton at home for eight weeks, following a five-day training program to ensure familiarity with the device. The study employs a multicenter, controlled, randomized, cross-over design, comparing the exoskeleton's impact on quality of life against a control phase involving standard physical activity advice. After the intervention, there will be a three-month follow-up to assess long-term effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsing-remitting multiple sclerosis, an EDSS score between 5 and 6.5, and who currently use a walking aid.
Not a fit: Patients who are unable to walk without assistance for 10 minutes or have significant psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the mobility and overall quality of life for patients with multiple sclerosis.
How similar studies have performed: While the use of robotic exoskeletons in rehabilitation is gaining interest, this specific approach for multiple sclerosis patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Saint-Genis-Laval, Auvergne-Rhône-Alpes and 5 other locations
- Hospices Civils de Lyon - Hôpital Henry Gabrielle — Saint-Genis-Laval, Auvergne-Rhône-Alpes, France (Recruiting)
- Pôle Saint Hélier — Rennes, Brittany Region, France (Recruiting)
- Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille — Lomme, Hauts-de-France, France (Recruiting)
- Centre de rééducation Fonctionnelle Propara-Montpellier — Montpellier, Occitanie, France (Recruiting)
- CHU Angers- SSR Les Capucins — Angers, Pays de la Loire Region, France (Recruiting)
- CHU Nantes site de Saint Jacques — Nantes, Pays de la Loire Region, France (Recruiting)
Study contacts
- Principal investigator: Philippe Gallien, Doctor — Pole Saint-Hélier
- Study coordinator: Phillipe Gallien, Doctor
- Email: philippe.gallien@pole-sthelier.com
- Phone: 0299295099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.