NCT04039841

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

July 22, 2019

Last Update Submit

April 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 month

Secondary Outcomes (3)

  • Evaluate the factors that predict a fall

    12 month

  • Assess the factors that predict a first fall

    6 and 12 month

  • Assess whether factors are predictive of the severity of a fall

    6 and 12 month

Study Arms (1)

Motor imagery evaluation

OTHER

cohort study

Diagnostic Test: Motor Imagery Test

Interventions

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.

Motor imagery evaluation

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHD Vendée

La Roche-sur-Yon, 85000, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Non-interventional Monocentric Prospective Non-intervention Research
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 31, 2019

Study Start

July 4, 2019

Primary Completion

June 20, 2024

Study Completion

December 20, 2024

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations