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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other | 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). |
|
| Arm B | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keeogo | Device | Keeogo is exoskeleton for walking assistance |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Non-Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phillipe Gallien, Doctor | Contact | 0299295099 | +33 | philippe.gallien@pole-sthelier.com |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Gallien, Doctor | Pole Saint-Hélier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital Henry Gabrielle | Recruiting | Saint-Genis-Laval | Auvergne-Rhône-Alpes | 69230 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42331578 | Derived | 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. |
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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.
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| adviced home practice |
| Other |
health tips for regular and appropriate physical activity |
|
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) |
| Pôle Saint Hélier | Recruiting | Rennes | Brittany Region | 35000 | France |
|
| Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille | Recruiting | Lomme | Hauts-de-France | 59160 | France |
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| Centre de rééducation Fonctionnelle Propara-Montpellier | Recruiting | Montpellier | Occitanie | 34090 | France |
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| CHU Angers- SSR Les Capucins | Recruiting | Angers | Pays de la Loire Region | 49103 | France |
|
| CHU Nantes site de Saint Jacques | Recruiting | Nantes | Pays de la Loire Region | 44093 | France |
|
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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