Function, Locomotion, Measurement and Inflammation (FoLoMI)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Ankylosing Spondylitis

Study type: Observational

Funder types: Other

Identifiers

NCT03761212

38RC17.158.

Details and patient eligibility

About

FoLoMI is a pilot study in which the investigators will seek to determine if gait spatio-temporal and kinematic parameters can explain the evolution of a functional score, the Bath Ankylosing Spondylitis Functional Index (BASFI), at 18 months.

The secondary objectives are: (1) to study the relationship between gait parameters measured at T0 and the BASFI at T0, (2) to study the relationship between gait parameters at T0 and the BASDAI at T0, (3) to assess general state of health of the patients and its evolution by appreciating: level of physical activity, state of fatigue, diurnal sleepiness and quality of life, and (4) to compare spatio-temporal gait parameters between patients and healthy controls.

Full description

This longitudinal cohort study is aiming to follow 60 persons with ankylosing spondylitis during 18 months. Assessments will be conducted at baseline and every 6 months.

An healthy control group of 30 persons will be included and age and sex matched to the first 30 patients.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ankylosing spondylitis or Axial Spondyloarthritis patient
• Patient able to walk at least 180 meters without technical help
• Stable treatment for 3 months
• Affiliated to a social security system

Exclusion criteria

• Concomitant musculo-skeletal disease
• Cardio-respiratory disease with an impact on locomotion
• Hips, ankle or knee arthroplasty (scheduled or done within 18 months)
• No french understanding
• Central or peripheric neurologic disease
• Other disease with impact on posture, locomotion or prehension
• Quickly evolutive disease (less than 12 month life expectancy)
• Chemotherapy or radiotherapy ongoing
• Patient who live more than 50 km away from Grenoble Hospital
• Willing of pregnancy within 18 months
• People protected by law (Article L1121.5 of Public Health Code)

Trial design

90 participants in 2 patient groups

Patient with ankylosing spondylitis or axial spondyloarthritis

Description:

No intervention - observational study

Healthy controls

Description:

Age and sex matched healthy controls