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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Keeogo
* Other: adviced home practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A<br>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). | Device: Keeogo<br>* Keeogo is exoskeleton for walking assistance<br>Other: adviced home practice<br>* health tips for regular and appropriate physical activity<br>|
| Other: Arm B<br>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) | Device: Keeogo<br>* Keeogo is exoskeleton for walking assistance<br>Other: adviced home practice<br>* health tips for regular and appropriate physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the quality of life assessed with the Functional Assessment Of Multiple Sclerosis questionnaire (change between two time points) | The Functional Assessment Of Multiple Sclerosis (FAMS) is a self-administered health questionnaire related to quality of life for patients with multiple sclerosis | Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking and balancing performance with the Keeogo exoskeleton (1) | Measured by 2 minutes walking test | after experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Walking and balancing performance with the Keeogo exoskeleton (2) | Measured by 10 meter walking test | after experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Walking and balancing performance with the Keeogo exoskeleton (3) | Measured by the Timed up and go Test | after experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Walking and balancing performance with the Keeogo exoskeleton (4) | Measured by Functional Stair Test (FST) | after experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Walking and balancing performance with the Keeogo exoskeleton (5) | Measured by the Sit to Stand Test (SST) | after experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Walking and balancing performance with the Keeogo exoskeleton (6) | Evaluations of spatio-temporal gait parameters using an instrumented walking system (Gaitrite®, Vicon® or Locometer® for example) | after experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Spasticity of the quadriceps, hamstrings and abductors muscles | Assessed manually by the Held and Tardieu Test | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Sense of self-efficacy | Measured by the Rosenberg Self-Efficacy Questionnaire | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| The average daily distance travelled | Measured by inertial units tracing the daily activity of the participants (descriptive daily distance travelled) | At study visits (Week 8, Week 24, Month 9) | 
| Fatigue | Measured by the French version of the fatigue impact scale in multiple sclerosis (EMIF-SEP) scored from 0 to 100% a low score is a better outcome | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Anxiety and depression | Measured by the Hospital Anxiety and Depression score (HAD) scored from 0 to 21 for both subtitles (Anxiety and depression) a low score is a better outcome | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Satisfaction with this new home technical aid | Evaluated via the French version of the QUEST questionnaire (ESAT questionnaire) | After experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Projection in use | Evaluated by a usage questionnaire (UTAUT-based already used in a walking exoskeleton context) | After experimental phase (Week 8 for Arm A; Week 24 for Arm B) | 
| Walking and balancing performance without exoskeleton (1) | Measured by the 2 minutes walking test | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Walking and balancing performance without exoskeleton (2) | Measured by the 10 meter walking test | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Walking and balancing performance without exoskeleton (3) | Measured by the Timed up and go Test | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Walking and balancing performance without exoskeleton (4) | Measured by the Functional Stair Test (FST) | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Walking and balancing performance without exoskeleton (5) | Measured by the Sit to Stand Test (SST) | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) | 
| Walking and balancing performance without exoskeleton (6) | Evaluations of spatio-temporal gait parameters using an instrumented walking system (Gaitrite®, Vicon® or Locometer® for example) | At all study visits (Screening, Week 8, Week 16, Week 24, Month 9) |