Clinical trial NCT05835622: Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.
Official title: Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After screening visit, patients are randomised between two Arms. Patients in Arm A start with experimental phase and after a wash-out period start the control phase (without exoskeleton). Patients randomised in Arm B start with the control phase and after the wash-out period start the experimental phase. After that, all patients have a follow-up period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
timeFrame: Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Secondary outcomes:
measure: Walking and balancing performance with the Keeogo exoskeleton (1)
timeFrame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Walking and balancing performance with the Keeogo exoskeleton (2)
timeFrame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Walking and balancing performance with the Keeogo exoskeleton (3)
timeFrame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Walking and balancing performance with the Keeogo exoskeleton (4)
timeFrame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Walking and balancing performance with the Keeogo exoskeleton (5)
timeFrame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Walking and balancing performance with the Keeogo exoskeleton (6)
timeFrame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Spasticity of the quadriceps, hamstrings and abductors muscles
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Sense of self-efficacy
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: The average daily distance travelled
timeFrame: At study visits (Week 8, Week 24, Month 9)
measure: Fatigue
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Anxiety and depression
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Satisfaction with this new home technical aid
timeFrame: After experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Projection in use
timeFrame: After experimental phase (Week 8 for Arm A; Week 24 for Arm B)
measure: Walking and balancing performance without exoskeleton (1)
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Walking and balancing performance without exoskeleton (2)
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Walking and balancing performance without exoskeleton (3)
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Walking and balancing performance without exoskeleton (4)
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Walking and balancing performance without exoskeleton (5)
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
measure: Walking and balancing performance without exoskeleton (6)
timeFrame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Other outcomes:
Locations:
city: Saint Genis Laval
country: France
facility: Hospices Civils de Lyon - Hôpital Henry Gabrielle
state: Auvergne-Rhône-Alpes
city: Rennes
country: France
facility: Pôle Saint Hélier
state: Bretagne
city: Lomme
country: France
facility: Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille
state: Hauts-de-France
city: Montpellier
country: France
facility: Centre de rééducation Fonctionnelle Propara-Montpellier
state: Occitanie
city: Angers
country: France
facility: CHU Angers- SSR Les Capucins
state: Pays De La Loire
city: Nantes
country: France
facility: CHU Nantes site de Saint Jacques
state: Pays De La Loire
Study officials:
affiliation: Pole Saint-Hélier
name: Philippe Gallien, Doctor
role: PRINCIPAL_INVESTIGATOR
References: