Is it Possible to Predict Falls With Motor Imagery
FallMI
Pilot Study to Predict Falls With Motor Imagery
1 other identifier
interventional
67
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
2 active sites
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
CompletedFirst Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2024
CompletedApril 27, 2026
April 1, 2026
5 years
July 22, 2019
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
OTHERcohort study
Interventions
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.
Eligibility Criteria
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
Centre Hospitalier Departemental
La Roche-sur-Yon, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- 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