Gait Parameters as Predictors of Functional and Activity Scores in Ankylosing Spondylitis : the FoLoMI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Gait speed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Gait speed
时间窗: Baseline : Day 0
Mean gait speed (m/s) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate.
Stride length
时间窗: Baseline : Day 0
Mean stride length (m) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate.
Double support time
时间窗: Baseline : Day 0
Double support time (%) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate.
Stance time
时间窗: Baseline : Day 0
Stance time (%) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate.
The Bath Ankylosing Spondylitis Functional Index (BASFI)
时间窗: 18 months
The self-administered Bath Ankylosing Functional Index (BASFI) measures functional consequences of ankylosing spondylitis (AS). The patient indicates its level of ability in ten domains of daily life: put the socks, bend to pick a pen from the floor, reach up to a high shelf, get up from a chair and from the floor, stand unsupported for 10 minutes, climb steps, look over the shoulder, do physically demanding activities and do a full days activities. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher is the score, higher are the functional consequences of AS.
Stride time
时间窗: Baseline : Day 0
Mean stride time (s) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate.
次要结局
- Evolution of the Bath Ankylosing Spondylitis Functional Index (BASFI)(From day 0 to 18-months)
- Evolution of physical activity(From day 0 to 18-months)
- Evolution of time to realize instrumented Timed Up and Go (iTUG)(From day 0 to 18-month)
- Evolution of daytime sleepiness(From day 0 to 18-months)
- Evolution of quality of life(From day 0 to 18-months)
- Evolution of six minute walk distance(From day 0 to 18-months)
- Evolution of work impairment(From day 0 to 18-month)
- Evolution of smoking status(From day 0 to 18-month)
- Evolution of social support(From day 0 to 18-month)
- Evolution of gait pattern(From day 0 to 18-months)
- Evolution of tiredness(From day 0 to 18-months)
- Evolution of lower limbs range of motion assessments(From day 0 to 18-months)
- Evolution of nicotine dependence(From day 0 to 18-month)
- Evolution of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(From day 0 to 18-months)
- Evolution of foot function(From day 0 to 18-months)