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

NCT05835622 | Recruiting

• 1 other identifier: 2021-A03094-37
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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)

• Walking and balancing performance with the Keeogo exoskeleton (3)

  after experimental phase (Week 8 for Arm A; Week 24 for Arm B)

• 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 (5)

  after experimental phase (Week 8 for Arm A; Week 24 for Arm B)

Study Arms (2)

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).

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)

Device: Keeogo; Other: adviced home practice

Interventions

Keeogo DEVICE

Keeogo is exoskeleton for walking assistance

Arm A; Arm B

adviced home practice OTHER

health tips for regular and appropriate physical activity

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Pôle Saint Hélier: lead

Study Sites (6)

Hospices Civils de Lyon - Hôpital Henry Gabrielle

Saint-Genis-Laval, Auvergne-Rhône-Alpes, 69230, France

RECRUITING

Pôle Saint Hélier

Rennes, Brittany Region, 35000, France

RECRUITING

Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, Hauts-de-France, 59160, France

RECRUITING

Centre de rééducation Fonctionnelle Propara-Montpellier

Montpellier, Occitanie, 34090, France

RECRUITING

CHU Angers- SSR Les Capucins

Angers, Pays de la Loire Region, 49103, France

RECRUITING

CHU Nantes site de Saint Jacques

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Philippe Gallien, Doctor

  Pole Saint-Hélier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillipe Gallien, Doctor

CONTACT

0299295099; philippe.gallien@pole-sthelier.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 28, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)