Towards the Use of Instrumented Tests for Screening the Risk of Falling in Patients With Chronic Illness.
Condition: Joint Osteoarthritis; Atherosclerosis of the Distal Arteries, Without Gangrene; Parkinson Disease; Chronic Obstructive Pulmonary Disease, Unspecified; Obesity, Unspecified
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Parkinson Disease; Atherosclerosis; Obesity; Chronic Disease; Gangrene
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology.
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Inertial sensors; Timed Up and Go test; 6-Minute Walk test; Fall; Risk of fall; Altered mobility; Chronic illness; Chronic pathologies; Physical capacities; Physical test; Activity limitations