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

Parkinson Disease Clinical Trial

— DETECACTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368858
• Other study ID #: RBHP 2020 REYNAUD
• Secondary ID: 2020-A00290-39
• Status: Completed
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: November 16, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Exploratory 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.

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	Day 0
Secondary	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.	day 0
Secondary	Weight (Kg).	Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.	day 0
Secondary	Height (cm).	Height will be measured with a wall mounted tape measure and according to the ISAK recommendations.	day 0
Secondary	Waist circumference (cm).	Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	day 0
Secondary	Hip circumference (cm).	Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	day 0
Secondary	Brachial circumference (cm).	Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	day 0
Secondary	Calf circumference (cm).	Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations.	day 0
Secondary	Body Mass Index (Kg/m²).	Description: BMI will be calculated (weight in kilograms divided by height in meters squared).	day 0
Secondary	Body composition.	Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.	day 0
Secondary	Self-Reported Number of Falls during the previous year	Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).	day 0
Secondary	Self-Reported Number of Falls during the previous year	Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).	Month 6
Secondary	Self-Reported Number of Falls during the previous year	Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).	Year 1
Secondary	Sarcopenia risk.	Sarcopenia risk will be evaluated with the SARC-F Questionnaire.	Day 0
Secondary	Balance confidence in performing various activities	Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	Statokinesigram surface area (mm²).	Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.	Day 0
Secondary	Stabilogram length (mm).	Stabilogram length will be measured with the STATIPRO® static posturography platform.	Day 0
Secondary	Maximal deflection (forward, backward left and right).	Maximal deflection will be measured with the STATIPRO® static posturography platform.	Day 0
Secondary	Velocity variations (mm/s).	Velocity variations will be measured with the STATIPRO® static posturography platform.	Day 0
Secondary	Romberg ratio according to sway area	Romberg ratio will be measured with the STATIPRO® static posturography platform	day 0
Secondary	Romberg ratio according to center of pressure path length.	Romberg ratio will be measured with the STATIPRO® static posturography platform.	day 0
Secondary	Plantar pressure ratio sway area.	: Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform	day 0
Secondary	Plantar pressure ratio length	Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.	day 0
Secondary	Walking velocity (cm/s).	Walking velocity will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Cadence (steps/min).	Cadence will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Step length (left and right foot) (cm)	: Step length will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Stride length (cm).	Stride length will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	: Single support time left and right foot (% of walking cycle)	Single support time will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Double support time (% of walking cycle).	Double support time will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Swing time (% of walking cycle).	: Swing time will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Swing phase (% of walking cycle).	Swing phase will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Stance phase (% of walking cycle).	: Stance phase will be measured with the GAITRite® Electronic Walkway.	day 0
Secondary	Functional capacity Timed-Up and Go	Functional capacity will be evaluated using the Timed-Up and Go test.	day 0
Secondary	Functional capacity TDM6	Functional capacity will be evaluated using the 6-minute walk test.	day 0
Secondary	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.	day 0
Secondary	Time (s) to complete the Timed-Up and Go test.	Time will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	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.	day 0
Secondary	Vertical angular speed (m/s) during the TUG test.	Vertical angular speed will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	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.	day 0
Secondary	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	day 0
Secondary	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.	day 0
Secondary	Duration (s) of the turn to sit phase during the TUG test.	Time will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	Total number of steps during the TUG test.	Steps will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	Average length of steps (m) during the TUG test.	Steps will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	Average walking speed (m/s) during the TUG test.	Walking speed will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	Number of steps during the 180° rotation phase of the TUG test.	Steps will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	Standard deviation of the duration of the step (s) during the TUG test.	Standard deviation will be measured with the mTUG® inertial sensor unit.	day 0
Secondary	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	day 0