Towards the Use of Instrumented Tests for Screening the Risk of Falling in Patients With Chronic Illness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Maximum voluntary isokinetic strength (Nm) of the quadriceps muscles in slow speed (60°/s) concentric contraction.
研究概览
简要总结
In patients with chronic illness, screening for falls and their health consequences are major public health issues. Muscle weakness, gait and balance disorders are among the most common risk factors for falling. Assessing these parameters would thus be a crucial step in the evaluation of the risk of falling, allowing to more precisely orient the management strategy. Combining inertial unit sensors with clinically validated tests can provide additional information to improve the assessment of fall risks. We therefore propose to constitute a monocentric exploratory study, testing a prognostic screening tool, in patients suffering from a chronic pathology, in order to assess the risk of falling in this population.
Considering the relationship between muscle weakness and the risk of falling, we can assume that a deficit in muscle strength will result in less vertical acceleration which could point to a muscle cause of the balance disorder and thus allow a finer detection of the risk of falling. On the other hand, we hypothesize that spinal static disorders in chronic pathologies and in particular osteoarthritis, as well as balance disorders linked to impaired deep sensitivity lead to an increase in oscillations of the trunk when walking which can cause postural balance disorders thus increasing the risk of falling.
详细描述
Investigators propose to constitute a prospective cohort of subjects carrying chronic disease. The main objective is to study the correlation between the vertical acceleration during the sit to stand phase of the instrumented Timed Up and Go test (TUG) and the isokinetic muscle strength of the quadriceps. In addition, as secondary objectives, we will study the potential correlations between the other parameters collected with the inertial sensors during instrumented tests (Timed-Up and Go test, and 6-Minute Walk Test) and the isokinetic muscle strength of the lower limb muscles, posturography parameters, gait parameters, apprehension of fall and others.
In the present protocol, parameters will be measured once at inclusion day (to). Only the falling incidences will be collected prospectively at 6 months and at 1 year from the inclusion day.
Statistical analyses will be carried out using Stata software (version 13, StataCorp, College Station, USA). Qualitative variables will be described in terms of numbers and associated percentages. The quantitative variables will be described in terms of numbers, associated mean and standard deviation, median and interquartile range. Wherever is possible, graphic representations will be associated with these analyses. All tests will be performed for a bilateral hypothesis and a p-value <5% will be considered statistically significant. For the main outcome, the Pearson correlation coefficient (or Spearman if data are not normally distributed) will be calculated with its 95% confidence interval. The analysis of the relationships between the continuous criteria will be carried out using Pearson correlation coefficients (or Spearman if data are not normally distributed).
The search for fall risk factors (at 6 months / 1 year) will be carried out using standard tests:
- Chi-square test (or exact Fisher test when appropriate) for the categorical criteria.
- Student test (or Mann and Whitney test if data not normally distributed) for continuous criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 18 to
- •Patients with chronic pathology contributing to impaired mobility.
- •Volunteers who have given their written consent.
- •Affiliated to French health care system (for France)
排除标准
- •Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
- •People with poorly controlled or unstable cardiovascular disease.
- •Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
- •Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
- •People refusing to participate.
- •Pregnant or lactating women.
研究组 & 干预措施
Cohort 1 : experimental group
Participants will be involved in an evaluation program combining, body composition measures, physical tests as well as self-administered questionnaires. Participants will be followed for 1 year with evaluations (occurrence of fall) taking place at 6 months and at 1 year.
干预措施: Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology. (Diagnostic Test)
结局指标
主要结局
Maximum voluntary isokinetic strength (Nm) of the quadriceps muscles in slow speed (60°/s) concentric contraction.
时间窗: Day 0
: Maximum voluntary isokinetic strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
Vertical acceleration in m/s² during the sit to stand phase of the Timed-Up and Go test.
时间窗: Day 0
Vertical acceleration will be collected with the mTUG® inertial sensor unit.
次要结局
- Demographics information(day 0)
- Brachial circumference (cm).(day 0)
- Body Mass Index (Kg/m²).(day 0)
- Body composition.(day 0)
- Self-Reported Number of Falls during the previous year(Year 1)
- Balance confidence in performing various activities(Day 0)
- Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).(Day 0)
- Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).(Day 0)
- Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).(Day 0)
- Romberg ratio according to center of pressure path length.(day 0)
- Plantar pressure ratio length(day 0)
- Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).(Day 0)
- Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).(Day 0)
- Statokinesigram surface area (mm²).(Day 0)
- Stabilogram length (mm).(Day 0)
- Romberg ratio according to sway area(day 0)
- Step length (left and right foot) (cm)(day 0)
- Stride length (cm).(day 0)
- Double support time (% of walking cycle).(day 0)
- Functional capacity TDM6(day 0)
- Calf circumference (cm).(day 0)
- Walking velocity (cm/s).(day 0)
- Cadence (steps/min).(day 0)
- : Single support time left and right foot (% of walking cycle)(day 0)
- Stance phase (% of walking cycle).(day 0)
- Vertical acceleration (m/s²) during the sit to stand phase of the Timed-Up and Go test (TUG).(day 0)
- Time (s) of the 180° rotation phase during the TUG test.(day 0)
- Duration (s) of the turn to sit phase during the TUG test.(day 0)
- Weight (Kg).(day 0)
- Height (cm).(day 0)
- Waist circumference (cm).(day 0)
- Hip circumference (cm).(day 0)
- Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).(Day 0)
- Maximal deflection (forward, backward left and right).(Day 0)
- Swing time (% of walking cycle).(day 0)
- Swing phase (% of walking cycle).(day 0)
- Time (s) to pass from the sitting position to the first step during the TUG test.(day 0)
- Sarcopenia risk.(Day 0)
- Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).(Day 0)
- Velocity variations (mm/s).(Day 0)
- Plantar pressure ratio sway area.(day 0)
- Time (s) to complete the Timed-Up and Go test.(day 0)
- Anteroposterior acceleration (m/s2) during stand to walk phase of the Timed-Up and Go test(day 0)
- Total number of steps during the TUG test.(day 0)
- Number of steps during the 180° rotation phase of the TUG test.(day 0)
- Functional capacity Timed-Up and Go(day 0)
- Vertical angular speed (m/s) during the TUG test.(day 0)
- Medio-lateral angular velocity (m/s) during the TUG test.(day 0)
- Average length of steps (m) during the TUG test.(day 0)
- Average walking speed (m/s) during the TUG test.(day 0)
- Standard deviation of the duration of the step (s) during the TUG test.(day 0)
- Spatio-temporal gait parameters (Average walking speed, step and stride length (right and left), cadence variability, variability in stride length, stance and swing phase, …) during the 6-minute Walk Test (6MWT).(day 0)
- Self-Reported Number of Falls during the previous year(day 0)
- Self-Reported Number of Falls during the previous year(Month 6)