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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04368858
Acronym
DETECACTI
Enrollment
120
Registered
2020-04-30
Start date
2020-08-28
Completion date
2022-11-16
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis of the Distal Arteries, Without Gangrene, Chronic Obstructive Pulmonary Disease, Unspecified, Joint Osteoarthritis, Obesity, Unspecified, Parkinson Disease

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

Brief 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.

Interventions

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

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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Vertical acceleration in m/s² during the sit to stand phase of the Timed-Up and Go test.Day 0Vertical acceleration will be collected with the mTUG® inertial sensor unit.
Maximum voluntary isokinetic strength (Nm) of the quadriceps muscles in slow speed (60°/s) concentric contraction.Day 0: Maximum voluntary isokinetic strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

Secondary

MeasureTime frameDescription
Demographics informationday 0Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events.
Weight (Kg).day 0Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
Height (cm).day 0Height will be measured with a wall mounted tape measure and according to the ISAK recommendations.
Waist circumference (cm).day 0Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Hip circumference (cm).day 0Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Brachial circumference (cm).day 0Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Calf circumference (cm).day 0Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Body Mass Index (Kg/m²).day 0Description: BMI will be calculated (weight in kilograms divided by height in meters squared).
Body composition.day 0Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
Self-Reported Number of Falls during the previous yearday 0Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).
Sarcopenia risk.Day 0Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
Balance confidence in performing various activitiesDay 0Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).Day 0: Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).Day 0Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).Day 0Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).Day 0Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).Day 0Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).Day 0Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).Day 0Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.
Statokinesigram surface area (mm²).Day 0Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
Stabilogram length (mm).Day 0Stabilogram length will be measured with the STATIPRO® static posturography platform.
Maximal deflection (forward, backward left and right).Day 0Maximal deflection will be measured with the STATIPRO® static posturography platform.
Velocity variations (mm/s).Day 0Velocity variations will be measured with the STATIPRO® static posturography platform.
Romberg ratio according to sway areaday 0Romberg ratio will be measured with the STATIPRO® static posturography platform
Romberg ratio according to center of pressure path length.day 0Romberg ratio will be measured with the STATIPRO® static posturography platform.
Plantar pressure ratio sway area.day 0: Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform
Plantar pressure ratio lengthday 0Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
Walking velocity (cm/s).day 0Walking velocity will be measured with the GAITRite® Electronic Walkway.
Cadence (steps/min).day 0Cadence will be measured with the GAITRite® Electronic Walkway.
Step length (left and right foot) (cm)day 0: Step length will be measured with the GAITRite® Electronic Walkway.
Stride length (cm).day 0Stride length will be measured with the GAITRite® Electronic Walkway.
: Single support time left and right foot (% of walking cycle)day 0Single support time will be measured with the GAITRite® Electronic Walkway.
Double support time (% of walking cycle).day 0Double support time will be measured with the GAITRite® Electronic Walkway.
Swing time (% of walking cycle).day 0: Swing time will be measured with the GAITRite® Electronic Walkway.
Swing phase (% of walking cycle).day 0Swing phase will be measured with the GAITRite® Electronic Walkway.
Stance phase (% of walking cycle).day 0: Stance phase will be measured with the GAITRite® Electronic Walkway.
Functional capacity Timed-Up and Goday 0Functional capacity will be evaluated using the Timed-Up and Go test.
Functional capacity TDM6day 0Functional capacity will be evaluated using the 6-minute walk test.
Vertical acceleration (m/s²) during the sit to stand phase of the Timed-Up and Go test (TUG).day 0Vertical acceleration will be measured with the mTUG® inertial sensor unit.
Time (s) to complete the Timed-Up and Go test.day 0Time will be measured with the mTUG® inertial sensor unit.
Anteroposterior acceleration (m/s2) during stand to walk phase of the Timed-Up and Go testday 0Anteroposterior acceleration will be measured with the mTUG® inertial sensor unit.
Vertical angular speed (m/s) during the TUG test.day 0Vertical angular speed will be measured with the mTUG® inertial sensor unit.
Medio-lateral angular velocity (m/s) during the TUG test.day 0Medio-lateral angular velocity (m/s) will be measured with the mTUG® inertial sensor unit.
Time (s) of the 180° rotation phase during the TUG test.day 0Time of the rotation phase will be measured with the mTUG® inertial sensor unit
Time (s) to pass from the sitting position to the first step during the TUG test.day 0Time will be measured with the mTUG® inertial sensor unit.
Duration (s) of the turn to sit phase during the TUG test.day 0Time will be measured with the mTUG® inertial sensor unit.
Total number of steps during the TUG test.day 0Steps will be measured with the mTUG® inertial sensor unit.
Average length of steps (m) during the TUG test.day 0Steps will be measured with the mTUG® inertial sensor unit.
Average walking speed (m/s) during the TUG test.day 0Walking speed will be measured with the mTUG® inertial sensor unit.
Number of steps during the 180° rotation phase of the TUG test.day 0Steps will be measured with the mTUG® inertial sensor unit.
Standard deviation of the duration of the step (s) during the TUG test.day 0Standard deviation will be measured with the mTUG® inertial sensor unit.
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 0Spatio-temporal gait parameters will be measured with the mGAIT® inertial unit sensors

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREmmanuel COUDEYRE

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026