Multiple Sclerosis
Conditions
Keywords
Actimyo, Accelerometry, Home monitoring
Brief summary
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification. The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.
Interventions
DEVICEActimyo
Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
Sponsors
SYSNAV
Centre Hospitalier Régional de la Citadelle
Centre Hospitalier Universitaire de Liege
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
all patients undergo clinical evaluation and wear Actimyo device in daily living to assess their gait and its evolution.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed MS diagnosis, * Over 18 years old, * Ambulant patients, * Signed informed consent, * No clinical and / or radiological relapse within 3 months. * EDSS \< or = à 5,5, * Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.
Exclusion criteria
* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection. * Any other previous or present pathology having an impact on motor function. * Recent surgery or trauma (less than 6 months) in the upper or lower limbs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 95th centile of stride velocity | 1 year | 95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). |
| 50th centile of stride velocity | 1 year | 50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second). |
| 95th centile of stride length | 1 year | 95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). |
| 50th centile of stride length | 1 year | 50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter). |
| Stance phase time | 1 year | Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage). |
Countries
Belgium, France
Outcome results
None listed