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Completed

NCT Number: NCT04368858

Towards the Use of Instrumented Tests for Screening the Risk of Falling in Patients With Chronic Illness.

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.

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Key information

Conditions

Joint Osteoarthritis Atherosclerosis of the Distal Arteries, Without Gangrene Basal Ganglia Diseases Body Weight Brain Diseases Central Nervous System Diseases Chronic Disease Chronic Obstructive Pulmonary Disease, Unspecified Disease Attributes Lung Diseases Lung Diseases, Obstructive Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Unspecified Overnutrition Overweight Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Synucleinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Man or woman aged 18 to 90.
  • Patients with chronic pathology contributing to impaired mobility.
  • Volunteers who have given their written consent.
  • Affiliated to French health care system (for France)

Exclusion criteria

  • 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.

Treatment and study plan

Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology.

Diagnostic Test

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.

Primary outcomes

  1. Vertical acceleration in m/s² during the sit to stand phase of the Timed-Up and Go test.

    Time frame: Day 0

    Vertical acceleration will be collected with the mTUG® inertial sensor unit.

  2. Maximum voluntary isokinetic strength (Nm) of the quadriceps muscles in slow speed (60°/s) concentric contraction.

    Time frame: Day 0

    : Maximum voluntary isokinetic strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

Secondary outcomes

  1. Demographics information

    Time frame: day 0

    Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events.

  2. Weight (Kg).

    Time frame: day 0

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

  3. Height (cm).

    Time frame: day 0

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations.

  4. Waist circumference (cm).

    Time frame: day 0

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  5. Hip circumference (cm).

    Time frame: day 0

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  6. Brachial circumference (cm).

    Time frame: day 0

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  7. Calf circumference (cm).

    Time frame: day 0

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

  8. Body Mass Index (Kg/m²).

    Time frame: day 0

    Description: BMI will be calculated (weight in kilograms divided by height in meters squared).

  9. Body composition.

    Time frame: day 0

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

  10. Self-Reported Number of Falls during the previous year

    Time frame: day 0

    Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).

  11. Self-Reported Number of Falls during the previous year

    Time frame: Month 6

    Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).

  12. Self-Reported Number of Falls during the previous year

    Time frame: Year 1

    Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).

  13. Sarcopenia risk.

    Time frame: Day 0

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

  14. Balance confidence in performing various activities

    Time frame: Day 0

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.

  15. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    Time frame: Day 0

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

  16. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  17. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  18. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  19. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

  20. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

  21. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Time frame: Day 0

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

  22. Statokinesigram surface area (mm²).

    Time frame: Day 0

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

  23. Stabilogram length (mm).

    Time frame: Day 0

    Stabilogram length will be measured with the STATIPRO® static posturography platform.

  24. Maximal deflection (forward, backward left and right).

    Time frame: Day 0

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

  25. Velocity variations (mm/s).

    Time frame: Day 0

    Velocity variations will be measured with the STATIPRO® static posturography platform.

  26. Romberg ratio according to sway area

    Time frame: day 0

    Romberg ratio will be measured with the STATIPRO® static posturography platform

  27. Romberg ratio according to center of pressure path length.

    Time frame: day 0

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

  28. Plantar pressure ratio sway area.

    Time frame: day 0

    : Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform

  29. Plantar pressure ratio length

    Time frame: day 0

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

  30. Walking velocity (cm/s).

    Time frame: day 0

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

  31. Cadence (steps/min).

    Time frame: day 0

    Cadence will be measured with the GAITRite® Electronic Walkway.

  32. Step length (left and right foot) (cm)

    Time frame: day 0

    : Step length will be measured with the GAITRite® Electronic Walkway.

  33. Stride length (cm).

    Time frame: day 0

    Stride length will be measured with the GAITRite® Electronic Walkway.

  34. : Single support time left and right foot (% of walking cycle)

    Time frame: day 0

    Single support time will be measured with the GAITRite® Electronic Walkway.

  35. Double support time (% of walking cycle).

    Time frame: day 0

    Double support time will be measured with the GAITRite® Electronic Walkway.

  36. Swing time (% of walking cycle).

    Time frame: day 0

    : Swing time will be measured with the GAITRite® Electronic Walkway.

  37. Swing phase (% of walking cycle).

    Time frame: day 0

    Swing phase will be measured with the GAITRite® Electronic Walkway.

  38. Stance phase (% of walking cycle).

    Time frame: day 0

    : Stance phase will be measured with the GAITRite® Electronic Walkway.

  39. Functional capacity Timed-Up and Go

    Time frame: day 0

    Functional capacity will be evaluated using the Timed-Up and Go test.

  40. Functional capacity TDM6

    Time frame: day 0

    Functional capacity will be evaluated using the 6-minute walk test.

  41. Vertical acceleration (m/s²) during the sit to stand phase of the Timed-Up and Go test (TUG).

    Time frame: day 0

    Vertical acceleration will be measured with the mTUG® inertial sensor unit.

  42. Time (s) to complete the Timed-Up and Go test.

    Time frame: day 0

    Time will be measured with the mTUG® inertial sensor unit.

  43. Anteroposterior acceleration (m/s2) during stand to walk phase of the Timed-Up and Go test

    Time frame: day 0

    Anteroposterior acceleration will be measured with the mTUG® inertial sensor unit.

  44. Vertical angular speed (m/s) during the TUG test.

    Time frame: day 0

    Vertical angular speed will be measured with the mTUG® inertial sensor unit.

  45. Medio-lateral angular velocity (m/s) during the TUG test.

    Time frame: day 0

    Medio-lateral angular velocity (m/s) will be measured with the mTUG® inertial sensor unit.

  46. Time (s) of the 180° rotation phase during the TUG test.

    Time frame: day 0

    Time of the rotation phase will be measured with the mTUG® inertial sensor unit

  47. Time (s) to pass from the sitting position to the first step during the TUG test.

    Time frame: day 0

    Time will be measured with the mTUG® inertial sensor unit.

  48. Duration (s) of the turn to sit phase during the TUG test.

    Time frame: day 0

    Time will be measured with the mTUG® inertial sensor unit.

  49. Total number of steps during the TUG test.

    Time frame: day 0

    Steps will be measured with the mTUG® inertial sensor unit.

  50. Average length of steps (m) during the TUG test.

    Time frame: day 0

    Steps will be measured with the mTUG® inertial sensor unit.

  51. Average walking speed (m/s) during the TUG test.

    Time frame: day 0

    Walking speed will be measured with the mTUG® inertial sensor unit.

  52. Number of steps during the 180° rotation phase of the TUG test.

    Time frame: day 0

    Steps will be measured with the mTUG® inertial sensor unit.

  53. Standard deviation of the duration of the step (s) during the TUG test.

    Time frame: day 0

    Standard deviation will be measured with the mTUG® inertial sensor unit.

  54. 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).

    Time frame: day 0

    Spatio-temporal gait parameters will be measured with the mGAIT® inertial unit sensors

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: DETECACTI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2020
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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