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

Multiple Sclerosis Clinical Trial

— EXHOMESEP  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05835622
• Other study ID #: 2021-A03094-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: February 2, 2026

Study information

• Verified date: April 2023
• Source: Pôle Saint Hélier
• Contact: Phillipe Gallien, Doctor
• Phone: 0299295099
• Email: philippe.gallien[@]pole-sthelier.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: February 2, 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Keeogo
Keeogo is exoskeleton for walking assistance

Other:
• adviced home practice
health tips for regular and appropriate physical activity

Locations

Country	Name	City	State
France	CHU Angers- SSR Les Capucins	Angers	Pays De La Loire
France	Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille	Lomme	Hauts-de-France
France	Centre de rééducation Fonctionnelle Propara-Montpellier	Montpellier	Occitanie
France	CHU Nantes site de Saint Jacques	Nantes	Pays De La Loire
France	Pôle Saint Hélier	Rennes	Bretagne
France	Hospices Civils de Lyon - Hôpital Henry Gabrielle	Saint Genis Laval	Auvergne-Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Pôle Saint Hélier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Sense of self-efficacy	Measured by the Rosenberg Self-Efficacy Questionnaire	At all study visits (Screening, Week 8, Week 16, Week 24, Month 9)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)