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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPôle Saint Hélier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Keeogo

    Device

    Keeogo is exoskeleton for walking assistance

  • adviced home practice

    Other intervention

    health tips for regular and appropriate physical activity

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Arm AOther 2 interventions
Group B: Arm BOther 2 interventions

Trial outcomes

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

Time frame
Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)

Secondary outcomes

1

Walking and balancing performance with the Keeogo exoskeleton (1)

Measured by 2 minutes walking test

Time frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
2

Walking and balancing performance with the Keeogo exoskeleton (2)

Measured by 10 meter walking test

Time frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
3

Walking and balancing performance with the Keeogo exoskeleton (3)

Measured by the Timed up and go Test

Time frame
after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
4

Walking and balancing performance with the Keeogo exoskeleton (4)

Measured by Functional Stair Test (FST)

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

Other outcomes

Sponsors and contacts

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