Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03761212
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2018-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Function, Locomotion, Measurement and Inflammation
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Gait Parameters as Predictors of Functional and Activity Scores in Ankylosing Spondylitis : the FoLoMI Study
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FoLoMI
Brief Summary:
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.
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.
Detailed 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.
An healthy control group of 30 persons will be included and age and sex matched to the first 30 patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: