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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Keeogo
  Keeogo is exoskeleton for walking assistance
• Другое adviced home practice
  health tips for regular and appropriate physical activity

Первичные конечные точки

• Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points) [Срок оценки: Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)]

Вторичные конечные точки (12)

• Walking and balancing performance with the Keeogo exoskeleton (1) [Срок оценки: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)]
• Walking and balancing performance with the Keeogo exoskeleton (2) [Срок оценки: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)]
• Walking and balancing performance with the Keeogo exoskeleton (3) [Срок оценки: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)]
• Walking and balancing performance with the Keeogo exoskeleton (4) [Срок оценки: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)]
• Walking and balancing performance with the Keeogo exoskeleton (5) [Срок оценки: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)]
• Walking and balancing performance with the Keeogo exoskeleton (6) [Срок оценки: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)]
• Spasticity of the quadriceps, hamstrings and abductors muscles [Срок оценки: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)]
• Sense of self-efficacy [Срок оценки: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)]
• The average daily distance travelled [Срок оценки: At study visits (Week 8, Week 24, Month 9)]
• Fatigue [Срок оценки: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)]
• Anxiety and depression [Срок оценки: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)]
• Satisfaction with this new home technical aid [Срок оценки: After experimental phase (Week 8 for Arm A; Week 24 for Arm B)]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 6 центров

• Hospices Civils de Lyon - Hôpital Henry Gabrielle — Saint-Genis-Laval
• Pôle Saint Hélier — Rennes
• Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille — Lomme
• Centre de rééducation Fonctionnelle Propara-Montpellier — Montpellier
• CHU Angers- SSR Les Capucins — Angers
• CHU Nantes site de Saint Jacques — Nantes

Публикации

• Leblong E, Billot M, Cecile D, Gelis A, Mickael D, Jacquin-Courtois S, Gross R, Le Meur C, Linda B, Carole A, Benoit N, Bastien F, Philippe G. Home-based exoskeleton use to improve quality of life in patients with multiple sclerosis: study protocol of a multicentre, randomised, cross-over trial. BMJ Open. 2026 Jun 22;16(6):e115237. doi: 10.1136/bmjopen-2025-115237. PMID 42331578

Идентификаторы

NCT: NCT05835622 · 2021-A03094-37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗