Joint OsteoarthritisDETECACTINCT04368858
Towards the Use of Instrumented Tests for Screening the Risk of Falling in Patients With Chronic Illness.
A study testing Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology. in people with Joint Osteoarthritis and Atherosclerosis of the Distal Arteries, Without Gangrene, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene, Parkinson Disease
- What is being tested?
- Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2020to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene, Parkinson Disease, Chronic Obstructive Pulmonary Disease, Unspecified, Obesity, Unspecified
- Being tested
- Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology.
- 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
- Medical subject headings
- Parkinson Disease, Pulmonary Disease, Chronic Obstructive, Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 : experimental group | Experimental | Participants will be involved in an evaluation program combining, body composition measures, physical tests as well as self-administered questionnaires. Participants will be followed for 1 year with evaluations (occurrence of fall) taking place at 6 months and at 1 year. Receives: Diagnostic Test: Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0
Secondary outcomes (54)
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.
Measured: day 0
Weight (Kg).
Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.
Measured: day 0
Height (cm).
Height will be measured with a wall mounted tape measure and according to the ISAK recommendations.
Measured: day 0
Waist circumference (cm).
Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Measured: day 0
Hip circumference (cm).
Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Measured: day 0
Brachial circumference (cm).
Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Measured: day 0
Calf circumference (cm).
Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations.
Measured: day 0
Body Mass Index (Kg/m²).
Description: BMI will be calculated (weight in kilograms divided by height in meters squared).
Measured: day 0
Body composition.
Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.
Measured: day 0
Self-Reported Number of Falls during the previous year
Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).
Measured: day 0
Self-Reported Number of Falls during the previous year
Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).
Measured: Month 6
Self-Reported Number of Falls during the previous year
Number of falls will be evaluated with the Elderly Fall Screening Test (EFST).
Measured: Year 1
Sarcopenia risk.
Sarcopenia risk will be evaluated with the SARC-F Questionnaire.
Measured: Day 0
Balance confidence in performing various activities
Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Statokinesigram surface area (mm²).
Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.
Measured: Day 0
Stabilogram length (mm).
Stabilogram length will be measured with the STATIPRO® static posturography platform.
Measured: Day 0
Maximal deflection (forward, backward left and right).
Maximal deflection will be measured with the STATIPRO® static posturography platform.
Measured: Day 0
Velocity variations (mm/s).
Velocity variations will be measured with the STATIPRO® static posturography platform.
Measured: Day 0
Romberg ratio according to sway area
Romberg ratio will be measured with the STATIPRO® static posturography platform
Measured: day 0
Romberg ratio according to center of pressure path length.
Romberg ratio will be measured with the STATIPRO® static posturography platform.
Measured: day 0
Plantar pressure ratio sway area.
: Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform
Measured: day 0
Plantar pressure ratio length
Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.
Measured: day 0
Walking velocity (cm/s).
Walking velocity will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Cadence (steps/min).
Cadence will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Step length (left and right foot) (cm)
: Step length will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Stride length (cm).
Stride length will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
: Single support time left and right foot (% of walking cycle)
Single support time will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Double support time (% of walking cycle).
Double support time will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Swing time (% of walking cycle).
: Swing time will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Swing phase (% of walking cycle).
Swing phase will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Stance phase (% of walking cycle).
: Stance phase will be measured with the GAITRite® Electronic Walkway.
Measured: day 0
Functional capacity Timed-Up and Go
Functional capacity will be evaluated using the Timed-Up and Go test.
Measured: day 0
Functional capacity TDM6
Functional capacity will be evaluated using the 6-minute walk test.
Measured: 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.
Measured: day 0
Time (s) to complete the Timed-Up and Go test.
Time will be measured with the mTUG® inertial sensor unit.
Measured: 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.
Measured: day 0
Vertical angular speed (m/s) during the TUG test.
Vertical angular speed will be measured with the mTUG® inertial sensor unit.
Measured: 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.
Measured: 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
Measured: 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.
Measured: day 0
Duration (s) of the turn to sit phase during the TUG test.
Time will be measured with the mTUG® inertial sensor unit.
Measured: day 0
Total number of steps during the TUG test.
Steps will be measured with the mTUG® inertial sensor unit.
Measured: day 0
Average length of steps (m) during the TUG test.
Steps will be measured with the mTUG® inertial sensor unit.
Measured: day 0
Average walking speed (m/s) during the TUG test.
Walking speed will be measured with the mTUG® inertial sensor unit.
Measured: day 0
Number of steps during the 180° rotation phase of the TUG test.
Steps will be measured with the mTUG® inertial sensor unit.
Measured: 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.
Measured: 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
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Aug 2020
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368858
- Sponsor's protocol ID
- RBHP 2020 REYNAUD
- Other IDs
- 2020-A00290-39
- Acronym
- DETECACTI
- Status last verified
- Aug 2026
- First submitted
- 27 Apr 2020
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pelletier Visa M, Dobija L, Verdilos A, Mullez A, Reynaud V, Gignoux P, Costes F, Coudeyre E. Correlation Between Instrumented Timed Up and Go Test Performance and Muscle Strength in Knee and Hip Osteoarthritis: An Exploratory, Cross-Sectional Study. Sensors (Basel). 2025 Dec 25;26(1):142. doi: 10.3390/s26010142.
PubMed 41516576
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards the Use of Instrumented Tests for Screening the Risk of Falling in Patients With Chronic Illness.
- ClinicalTrials.gov ID
- NCT04368858
- Acronym / sponsor ID
- DETECACTI / RBHP 2020 REYNAUD
- Conditions
- Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene, Parkinson Disease, Chronic Obstructive Pulmonary Disease, Unspecified, Obesity, Unspecified
- Keywords
- Inertial sensors, Timed Up and Go test, 6-Minute Walk test, Fall, Risk of fall, Altered mobility, Chronic illness, Chronic pathologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : experimental group | Experimental | Diagnostic Test: Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology.Participants will be involved in an evaluation program combining, body composition measures, physical tests as well as self-administered questionnaires. Participants will be followed for 1 year with evaluations (occurrence of fall) taking place at 6 months and at 1 year. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Cohort 1 : experimental group |
Primary outcome
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.
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.
54 secondary outcomes
Demographics information
Time frame: day 0
Weight (Kg).
Time frame: day 0
Height (cm).
Time frame: day 0
Waist circumference (cm).
Time frame: day 0
Hip circumference (cm).
Time frame: day 0
Brachial circumference (cm).
Time frame: day 0
Calf circumference (cm).
Time frame: day 0
Body Mass Index (Kg/m²).
Time frame: day 0
Body composition.
Time frame: day 0
Self-Reported Number of Falls during the previous year
Time frame: day 0
Self-Reported Number of Falls during the previous year
Time frame: Month 6
Self-Reported Number of Falls during the previous year
Time frame: Year 1
Sarcopenia risk.
Time frame: Day 0
Balance confidence in performing various activities
Time frame: Day 0
Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).
Time frame: Day 0
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 240°/s (Nm).
Time frame: Day 0
Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).
Time frame: Day 0
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 240°/s (Nm).
Time frame: Day 0
Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).
Time frame: Day 0
Statokinesigram surface area (mm²).
Time frame: Day 0
Stabilogram length (mm).
Time frame: Day 0
Maximal deflection (forward, backward left and right).
Time frame: Day 0
Velocity variations (mm/s).
Time frame: Day 0
Romberg ratio according to sway area
Time frame: day 0
Romberg ratio according to center of pressure path length.
Time frame: day 0
Plantar pressure ratio sway area.
Time frame: day 0
Plantar pressure ratio length
Time frame: day 0
Walking velocity (cm/s).
Time frame: day 0
Cadence (steps/min).
Time frame: day 0
Step length (left and right foot) (cm)
Time frame: day 0
Stride length (cm).
Time frame: day 0
: Single support time left and right foot (% of walking cycle)
Time frame: day 0
Double support time (% of walking cycle).
Time frame: day 0
Swing time (% of walking cycle).
Time frame: day 0
Swing phase (% of walking cycle).
Time frame: day 0
Stance phase (% of walking cycle).
Time frame: day 0
Functional capacity Timed-Up and Go
Time frame: day 0
Functional capacity TDM6
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 41516576Pelletier Visa M, Dobija L, Verdilos A, Mullez A, Reynaud V, Gignoux P, Costes F, Coudeyre E. Correlation Between Instrumented Timed Up and Go Test Performance and Muscle Strength in Knee and Hip Osteoarthritis: An Exploratory, Cross-Sectional Study. Sensors (Basel). 2025 Dec 25;26(1):142. doi: 10.3390/s26010142.
Related trials for Joint Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COUDEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology. in people with Joint Osteoarthritis and Atherosclerosis of the Distal Arteries, Without Gangrene, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical acceleration in m/s² during the sit to stand phase of the Timed-Up and Go test. (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.