Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 6
- Primary Endpoint
- Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A
8 weeks of using keeogo at home (experimental phase) followed by 8 weeks of wash-up and then followed by 8 weeks of recommended home practise (control phase).
Intervention: adviced home practice (Other)
Arm A
8 weeks of using keeogo at home (experimental phase) followed by 8 weeks of wash-up and then followed by 8 weeks of recommended home practise (control phase).
Intervention: Keeogo (Device)
Arm B
8 weeks of recommended home practise (control phase) followed by 8 weeks of wash-up and then followed by 8 weeks of using keeogo at home (experimental phase)
Intervention: Keeogo (Device)
Arm B
8 weeks of recommended home practise (control phase) followed by 8 weeks of wash-up and then followed by 8 weeks of using keeogo at home (experimental phase)
Intervention: adviced home practice (Other)
Outcomes
Primary Outcomes
Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
Time Frame: Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
The Functional Assessment Of Multiple Sclerosis (FAMS) is a self-administered health questionnaire related to quality of life for patients with multiple sclerosis
Secondary Outcomes
- Anxiety and depression(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Spasticity of the quadriceps, hamstrings and abductors muscles(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (3)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance with the Keeogo exoskeleton (4)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance with the Keeogo exoskeleton (3)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Satisfaction with this new home technical aid(After experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Projection in use(After experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance without exoskeleton (6)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance with the Keeogo exoskeleton (5)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance with the Keeogo exoskeleton (6)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Sense of self-efficacy(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (1)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (4)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance with the Keeogo exoskeleton (1)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance with the Keeogo exoskeleton (2)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- The average daily distance travelled(At study visits (Week 8, Week 24, Month 9))
- Fatigue(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (2)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (5)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))