Multiple SclerosisEXHOMESEPNCT05835622
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients.
A study testing Keeogo and adviced home practice in people with Multiple Sclerosis, run by Pôle Saint Hélier at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Keeogo and adviced home practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Feb 2024to 18 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 31Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers- SSR Les Capucins
Angers, Pays de la Loire Region, 49103
Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille
Lomme, Hauts-de-France, 59160
Centre de rééducation Fonctionnelle Propara-Montpellier
Montpellier, Occitanie, 34090
CHU Nantes site de Saint Jacques
Nantes, Pays de la Loire Region, 44093
Pôle Saint Hélier
Rennes, Brittany Region, 35000
Hospices Civils de Lyon - Hôpital Henry Gabrielle
Saint-Genis-Laval, Auvergne-Rhône-Alpes, 69230
About this study
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.
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Keeogo, adviced home practice
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeeogoDevice
Keeogo is exoskeleton for walking assistance
adviced home practiceOther
health tips for regular and appropriate physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Keeogo; Other: adviced home practice |
| 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) Receives: Device: Keeogo; Other: adviced home practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Secondary outcomes (19)
Walking and balancing performance with the Keeogo exoskeleton (1)
Measured by 2 minutes walking test
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Sense of self-efficacy
Measured by the Rosenberg Self-Efficacy Questionnaire
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Feb 2024
- Primary completion18 Sep 2026
- Study completion18 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Gallien, Doctor, Principal investigator, Pole Saint-Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835622
- Sponsor's protocol ID
- 2021-A03094-37
- Acronym
- EXHOMESEP
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42331578
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05835622
- Acronym / sponsor ID
- EXHOMESEP / 2021-A03094-37
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- 18 Sep 2026 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Device: Keeogo, Other: adviced home practice8 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 | Device: Keeogo, Other: adviced home practice8 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KeeogoKeeogo is exoskeleton for walking assistance | Device | Arm A, Arm B |
| adviced home practicehealth tips for regular and appropriate physical activity | Other | Arm A, Arm B |
Primary outcome
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
19 secondary outcomes
Walking and balancing performance with the Keeogo exoskeleton (1)
Time frame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and balancing performance with the Keeogo exoskeleton (2)
Time frame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and balancing performance with the Keeogo exoskeleton (3)
Time frame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and balancing performance with the Keeogo exoskeleton (4)
Time frame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and balancing performance with the Keeogo exoskeleton (5)
Time frame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and balancing performance with the Keeogo exoskeleton (6)
Time frame: after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Spasticity of the quadriceps, hamstrings and abductors muscles
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Sense of self-efficacy
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
The average daily distance travelled
Time frame: At study visits (Week 8, Week 24, Month 9)
Fatigue
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Anxiety and depression
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Satisfaction with this new home technical aid
Time frame: After experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Projection in use
Time frame: After experimental phase (Week 8 for Arm A; Week 24 for Arm B)
Walking and balancing performance without exoskeleton (1)
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Walking and balancing performance without exoskeleton (2)
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Walking and balancing performance without exoskeleton (3)
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Walking and balancing performance without exoskeleton (4)
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Walking and balancing performance without exoskeleton (5)
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Walking and balancing performance without exoskeleton (6)
Time frame: At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 42331578Leblong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Gallien, Doctor principal investigator
Pole Saint-Hélier
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keeogo and adviced home practice in people with Multiple Sclerosis, run by Pôle Saint Hélier at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05835622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.