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.
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. These analyses will be completed using a logistic regression model by adjusting to the clinically relevant criteria or highlighted in the univariate analysis. Results will be presented as an odd ratio with their 95% confidence interval Little or no missing data is expected on the main criteria, however if a rate of missing data\> 5% is observed, a sensitivity analysis for missing data will be carried out in order to characterize their nature (MCAR, MAR, MNAR) in order to propose the most suitable imputation method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
In the Mobility Exploration Unit of the University Hospital of Clermont-Ferrand, patients with chronic illnesses undergo a complete assessment of their physical capacities as well as their nutritional status. For the purpose of this protocol, patients will have to perform 2 functional tests, namely the TM6 and the TUG, while being equipped with inertial sensor units (mTUG® and mGAIT®). The data of the gait analysis, posturography and strength analyses as well as the questionnaires' scores will be taken into account in this research. At 6 months and at 1 year, occurrence of a fall will be recorded in order to prospectively monitor this parameter.
Chu Clermont Ferrand
Clermont-Ferrand, France
Vertical acceleration in m/s² during the sit to stand phase of the Timed-Up and Go test.
Vertical acceleration will be collected with the mTUG® inertial sensor unit.
Time frame: Day 0
Maximum voluntary isokinetic strength (Nm) of the quadriceps muscles in slow speed (60°/s) concentric contraction.
: Maximum voluntary isokinetic strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Demographics information
Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events.
Time frame: day 0
Weight (Kg).
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
Time frame: day 0
Height (cm).
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations.
Time frame: day 0
Waist circumference (cm).
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Time frame: day 0
Hip circumference (cm).
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Time frame: day 0
Brachial circumference (cm).
Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Time frame: day 0
Calf circumference (cm).
Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Time frame: day 0
Body Mass Index (Kg/m²).
Description: BMI will be calculated (weight in kilograms divided by height in meters squared).
Time frame: day 0
Body composition.
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
Time frame: day 0
Self-Reported Number of Falls during the previous year
Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).
Time frame: day 0
Self-Reported Number of Falls during the previous year
Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).
Time frame: Month 6
Self-Reported Number of Falls during the previous year
Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).
Time frame: Year 1
Sarcopenia risk.
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
Time frame: Day 0
Balance confidence in performing various activities
Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.
Time frame: Day 0
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.
Time frame: Day 0
Statokinesigram surface area (mm²).
Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
Time frame: Day 0
Stabilogram length (mm).
Stabilogram length will be measured with the STATIPRO® static posturography platform.
Time frame: Day 0
Maximal deflection (forward, backward left and right).
Maximal deflection will be measured with the STATIPRO® static posturography platform.
Time frame: Day 0
Velocity variations (mm/s).
Velocity variations will be measured with the STATIPRO® static posturography platform.
Time frame: Day 0
Romberg ratio according to sway area
Romberg ratio will be measured with the STATIPRO® static posturography platform
Time frame: day 0
Romberg ratio according to center of pressure path length.
Romberg ratio will be measured with the STATIPRO® static posturography platform.
Time frame: day 0
Plantar pressure ratio sway area.
: Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform
Time frame: day 0
Plantar pressure ratio length
Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
Time frame: day 0
Walking velocity (cm/s).
Walking velocity will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Cadence (steps/min).
Cadence will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Step length (left and right foot) (cm)
: Step length will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Stride length (cm).
Stride length will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
: Single support time left and right foot (% of walking cycle)
Single support time will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Double support time (% of walking cycle).
Double support time will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Swing time (% of walking cycle).
: Swing time will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Swing phase (% of walking cycle).
Swing phase will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Stance phase (% of walking cycle).
: Stance phase will be measured with the GAITRite® Electronic Walkway.
Time frame: day 0
Functional capacity Timed-Up and Go
Functional capacity will be evaluated using the Timed-Up and Go test.
Time frame: day 0
Functional capacity TDM6
Functional capacity will be evaluated using the 6-minute walk test.
Time frame: day 0
Vertical acceleration (m/s²) during the sit to stand phase of the Timed-Up and Go test (TUG).
Vertical acceleration will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Time (s) to complete the Timed-Up and Go test.
Time will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Anteroposterior acceleration (m/s2) during stand to walk phase of the Timed-Up and Go test
Anteroposterior acceleration will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Vertical angular speed (m/s) during the TUG test.
Vertical angular speed will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Medio-lateral angular velocity (m/s) during the TUG test.
Medio-lateral angular velocity (m/s) will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Time (s) of the 180° rotation phase during the TUG test.
Time of the rotation phase will be measured with the mTUG® inertial sensor unit
Time frame: day 0
Time (s) to pass from the sitting position to the first step during the TUG test.
Time will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Duration (s) of the turn to sit phase during the TUG test.
Time will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Total number of steps during the TUG test.
Steps will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Average length of steps (m) during the TUG test.
Steps will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Average walking speed (m/s) during the TUG test.
Walking speed will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Number of steps during the 180° rotation phase of the TUG test.
Steps will be measured with the mTUG® inertial sensor unit.
Time frame: day 0
Standard deviation of the duration of the step (s) during the TUG test.
Standard deviation will be measured with the mTUG® inertial sensor unit.
Time frame: 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).
Spatio-temporal gait parameters will be measured with the mGAIT® inertial unit sensors
Time frame: day 0
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