Fall PatientsFallMINCT04039841
Is it Possible to Predict Falls With Motor Imagery
A study testing Motor Imagery Test in people with Fall Patients, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
At Departmental Hospital Centre, a primary and secondary screening program for osteoporosis was set up in 2014 in the medical services (excluding oncology), gynaecology, outpatient surgery and orthopaedics. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fall Patients
- What is being tested?
- Motor Imagery Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jul 2019to 20 Dec 2024
- 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 50 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have been screened for osteoporosis at CHD (aged 50 to 85 years)
- Proven presence of osteoporotic risk (positive response to screening tests),
- No lower limb fractures making walking impossible,
- Realization of iTUG and rTUG.
- No objection to the collection and analysis of personal data collected,
- Patient can be followed during the study period (12 months),
- Patient followed by a treating physician and having given his or her consent for him or her to be contacted as part of the study.
Who cannot join
- Insane patient
- Deaf patient
- Complete blind patient
- Patient unable to express himself
- Patient at the end of life
- Patient already treated for osteoporosis or recent DXA less than 3 years old at the time of screening
- Patient who has not been screened for osteoporosis at the CHD
- Presence of equipment (e.g. infusion) making it impossible to walk or rendering the reliability of TUGs obsolete,
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHD Vendée
La Roche-sur-Yon, 85000
Centre Hospitalier Departemental
La Roche-sur-Yon
About this study
Official title: Pilot Study to Predict Falls With Motor Imagery
At Departmental Hospital Centre, a primary and secondary screening program for osteoporosis was set up in 2014 in the medical services (excluding oncology), gynaecology, outpatient surgery and orthopaedics. Patients who consulted outpatients in the emergency room were not taken into account due to the 24-hour opening hours. The objective of this program was to identify all patients at risk of osteoporosis; i. e. not only patients with a recent or previous fracture history, but also patients with osteoporosis risk factors without a history of fracture to date. This is in order to propose a prevention strategy to referring physicians and thus reduce the risk of fractures. The handover of the Timed Up and Go designed and physically carried out was added in July 2017 to the management of patients as part of this screening.
During this screening, patients are asked to perform 2 realized Timed Up and Go (rTUG), followed by 2 imagined Timed Up and Go (iTUG).
Read more
The interest in preventing falls in osteoporotic patients leads investigators to propose this evaluation as part of this "osteoporosis" screening. The investigators will offer patients benefiting from osteoporosis screening as part of the process already in place at Departmental Hospital Centre to participate in the FallMi study. If agreement is reached, the patient's treating physician will be contacted to collect data on the occurrence of falls in these patients. After a request by mail, an email will be sent to the attending physicians of each patient at 6 months, then one year after the completion of the TUG. This email will ask physicians about the presence of a fall that has occurred since the TUGs were performed, as well as the severity of this possible fall.
Investigators objective is to evaluate rTUG and iTUG as predictive factors of a fall with moderate to fatal consequences.
Investigators hypothesize that a lower isochrony between rTUG and iTUG is predictive of a risk of falling.
Read the detailed description
Fall of the elderly is a major public health problem, especially in people with fragile bones. Various tools are available to identify high-risk subjects. Timed Up and Go (TUG) is a clinical test used as a predictive test of fall. However, its real usefulness remains uncertain. The degradation of TUG appears to be validated after the fall, but discussed as a prediction of a future fall.
On the other hand, human movement is separable into 2 phases, a programming phase (anticipation) and an execution phase. Movement programming can be reliably assessed through a simple test that evaluates the concordance between the duration of an imagined practice and a physical practice . Adapted to Timed Up and Go (= |realizedTUG -imaginedTUG|), the degradation of this Isochronic Index clinically marks a structural and functional degradation of cognitive abilities . In addition, the decrease in isochrony is correlated with the decrease in walking speed during the double task. This loss of isochrony could thus indicate a risk of falling due to poor anticipation of real motor skills.
At Departmental Hospital Centre, a primary and secondary screening program for osteoporosis was set up in 2014 in the medical services (excluding oncology), gynaecology, outpatient surgery and orthopaedics. Patients who consulted outpatients in the emergency room were not taken into account due to the 24-hour opening hours. The objective of this program was to identify all patients at risk of osteoporosis; i. e. not only patients with a recent or previous fracture history, but also patients with osteoporosis risk factors without a history of fracture to date. This is in order to propose a prevention strategy to referring physicians and thus reduce the risk of fractures. The handover of the Timed Up and Go designed and physically carried out was added in July 2017 to the management of patients as part of this screening.
During this screening, patients are asked to perform 2 realized Timed Up and Go (rTUG), followed by 2 imagined Timed Up and Go (iTUG).
The interest in preventing falls in osteoporotic patients leads us to propose this evaluation as part of this "osteoporosis" screening. This study wills offer patients benefiting from osteoporosis screening as part of the process already in place at CHD to participate in the FallMi study. If agreement is reached, the patient's treating physician will be contacted to collect data on the occurrence of falls in these patients. After a request by mail, an email will be sent to the attending physicians of each patient at 6 months, then one year after the completion of the TUG. This email will ask the doctors about the presence of a fall that has occurred since the TUGs were performed, as well as the severity of this possible fall.
Investigators objective is to evaluate rTUG and iTUG as predictive factors of a fall with moderate to fatal consequences.
Investigators hypothesize that a lower isochrony between rTUG and iTUG is predictive of a risk of falling.
- Conditions
- Fall Patients
- Being tested
- Motor Imagery Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery TestDiagnostic test
Imagined Timed Up and Go (iTUG) is the imagined version of the actual Timed Up and Go (rTUG) described above). It is possible to calculate the absolute value of the difference between the time of execution of the TUG imagined and actually executed. This difference is called isochrony index. The alteration of this isochrony index is correlated with the decrease in walking speed during the double task. This test is performed during the osteoporosis screening consultation.
For patients who agree to participate in the FallMI study, the name and contact information of the attending physician will be collected during the same consultation.
Standardised email will be sent to the attending physicians to collect the presence of falls and its consequences. They will be classified as fatal, severe, moderate and inconsequential.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery evaluation | Other | cohort study Receives: Diagnostic Test: Motor Imagery Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
existence of an isochronic deficit between the imagined Timed Up and Go and the Timed Up and Go correlated with presence of a fall
- Isochronic index =| rTUG-iTUG | (Absolute value of the difference between the execution time of the rTUG and the iTUG)
Measured: 6 month
Secondary outcomes (3)
Evaluate the factors that predict a fall
- Isochronic index =| rTUG-iTUG | (Absolute value of the difference between the execution time of the rTUG and the iTUG)
Measured: 12 month
Assess the factors that predict a first fall
- Isochronic index =| rTUG-iTUG | (Absolute value of the difference between the execution time of the rTUG and the iTUG)
Measured: 6 and 12 month
Assess whether factors are predictive of the severity of a fall
- Isochronic index =| rTUG-iTUG | (Absolute value of the difference between the execution time of the rTUG and the iTUG)
Measured: 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start4 Jul 2019
- Primary completion20 Jun 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-interventional Monocentric Prospective Non-intervention Research
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039841
- Sponsor's protocol ID
- CHD 032-18
- Acronym
- FallMI
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2019
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Predict Falls With Motor Imagery
- ClinicalTrials.gov ID
- NCT04039841
- Acronym / sponsor ID
- FallMI / CHD 032-18
- Conditions
- Fall Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 31 Jul 2019 (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.
At Departmental Hospital Centre, a primary and secondary screening program for osteoporosis was set up in 2014 in the medical services (excluding oncology), gynaecology, outpatient surgery and orthopaedics. Patients who consulted outpatients in the emergency room were not taken into account due to the 24-hour opening hours. The objective of this program was to identify all patients at risk of osteoporosis; i. e. not only patients with a recent or previous fracture history, but also patients with osteoporosis risk factors without a history of fracture to date. This is in order to propose a prevention strategy to referring physicians and thus reduce the risk of fractures. The handover of the Timed Up and Go designed and physically carried out was added in July 2017 to the management of patients as part of this screening.
During this screening, patients are asked to perform 2 realized Timed Up and Go (rTUG), followed by 2 imagined Timed Up and Go (iTUG).
The interest in preventing falls in osteoporotic patients leads investigators to propose this evaluation as part of this "osteoporosis" screening. The investigators will offer patients benefiting from osteoporosis screening as part of the process already in place at Departmental Hospital Centre to participate in the FallMi study. If agreement is reached, the patient's treating physician will be contacted to collect data on the occurrence of falls in these patients. After a request by mail, an email will be sent to the attending physicians of each patient at 6 months, then one year after the completion of the TUG. This email will ask physicians about the presence of a fall that has occurred since the TUGs were performed, as well as the severity of this possible fall.
Investigators objective is to evaluate rTUG and iTUG as predictive factors of a fall with moderate to fatal consequences.
Investigators hypothesize that a lower isochrony between rTUG and iTUG is predictive of a risk of falling.
Detailed description
Fall of the elderly is a major public health problem, especially in people with fragile bones. Various tools are available to identify high-risk subjects. Timed Up and Go (TUG) is a clinical test used as a predictive test of fall. However, its real usefulness remains uncertain. The degradation of TUG appears to be validated after the fall, but discussed as a prediction of a future fall.
On the other hand, human movement is separable into 2 phases, a programming phase (anticipation) and an execution phase. Movement programming can be reliably assessed through a simple test that evaluates the concordance between the duration of an imagined practice and a physical practice . Adapted to Timed Up and Go (= |realizedTUG -imaginedTUG|), the degradation of this Isochronic Index clinically marks a structural and functional degradation of cognitive abilities . In addition, the decrease in isochrony is correlated with the decrease in walking speed during the double task. This loss of isochrony could thus indicate a risk of falling due to poor anticipation of real motor skills.
At Departmental Hospital Centre, a primary and secondary screening program for osteoporosis was set up in 2014 in the medical services (excluding oncology), gynaecology, outpatient surgery and orthopaedics. Patients who consulted outpatients in the emergency room were not taken into account due to the 24-hour opening hours. The objective of this program was to identify all patients at risk of osteoporosis; i. e. not only patients with a recent or previous fracture history, but also patients with osteoporosis risk factors without a history of fracture to date. This is in order to propose a prevention strategy to referring physicians and thus reduce the risk of fractures. The handover of the Timed Up and Go designed and physically carried out was added in July 2017 to the management of patients as part of this screening.
During this screening, patients are asked to perform 2 realized Timed Up and Go (rTUG), followed by 2 imagined Timed Up and Go (iTUG).
The interest in preventing falls in osteoporotic patients leads us to propose this evaluation as part of this "osteoporosis" screening. This study wills offer patients benefiting from osteoporosis screening as part of the process already in place at CHD to participate in the FallMi study. If agreement is reached, the patient's treating physician will be contacted to collect data on the occurrence of falls in these patients. After a request by mail, an email will be sent to the attending physicians of each patient at 6 months, then one year after the completion of the TUG. This email will ask the doctors about the presence of a fall that has occurred since the TUGs were performed, as well as the severity of this possible fall.
Investigators objective is to evaluate rTUG and iTUG as predictive factors of a fall with moderate to fatal consequences.
Investigators hypothesize that a lower isochrony between rTUG and iTUG is predictive of a risk of falling.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-interventional Monocentric Prospective Non-intervention Research
| Arm | Type | Receives |
|---|---|---|
| Motor imagery evaluation | Other | Diagnostic Test: Motor Imagery Testcohort study |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have been screened for osteoporosis at CHD (aged 50 to 85 years)
- Proven presence of osteoporotic risk (positive response to screening tests),
- No lower limb fractures making walking impossible,
- Realization of iTUG and rTUG.
- No objection to the collection and analysis of personal data collected,
Key exclusion criteria (8 listed)
- Insane patient
- Deaf patient
- Complete blind patient
- Patient unable to express himself
- Patient at the end of life
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 |
|---|---|---|
| Motor Imagery TestImagined Timed Up and Go (iTUG) is the imagined version of the actual Timed Up and Go (rTUG) described above). It is possible to calculate the absolute value of the difference between the time of execution of the TUG imagined and actually executed. This difference is called isochrony index. The alteration of this isochrony index is correlated with the decrease in walking speed during the double task. This test is performed during the osteoporosis screening consultation. For patients who agree to participate in the FallMI study, the name and contact information of the attending physician will be collected during the same consultation. Standardised email will be sent to the attending physicians to collect the presence of falls and its consequences. They will be classified as fatal, severe, moderate and inconsequential. | Diagnostic test | Motor imagery evaluation |
Primary outcome
existence of an isochronic deficit between the imagined Timed Up and Go and the Timed Up and Go correlated with presence of a fall
Time frame: 6 month
- Isochronic index =| rTUG-iTUG | (Absolute value of the difference between the execution time of the rTUG and the iTUG)
3 secondary outcomes
Evaluate the factors that predict a fall
Time frame: 12 month
Assess the factors that predict a first fall
Time frame: 6 and 12 month
Assess whether factors are predictive of the severity of a fall
Time frame: 6 and 12 month
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 27 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery Test in people with Fall Patients, run by Centre Hospitalier Departemental Vendee at 2 sites 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 7 inclusion and 8 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
existence of an isochronic deficit between the imagined Timed Up and Go and the Timed Up and Go correlated with presence of a fall (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026.