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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00770-57 | Other Identifier | IDRCB |
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| Name | Class |
|---|---|
| Université de Technologie de Compiegne | OTHER |
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The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy.
The fracture of the upper end of the femur (EFSF) is a pathology:
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.
The aging of the population is a major public health problem with its multifactorial impact, quality of life and the maintenance of autonomy.
The upper femoral fracture (UFF) is a common pathology: in France, it concerns nearly 80.000 patients per year, 83% of whom are aged 75 (DREES, 2011).
The UFF is a pathology with serious consequences, on the mortality but also on the functional level, since 40% of the patients will not recover their walking capacity previous to 6 months, only 13% of the patients over 85 years old will walk unaided to 4 months and 11% of patients will be newly admitted to an institution within 6 months of the fracture (UPOG data, 20% for patients with major neurocognitive disorders, 4% for others). In the literature, at least 25% of elderly people will not recover their previous walking ability, especially for transfers, walking and climbing stairs (Alarcon 2011, Arinzon 2010, Visser 2000).
The UFF is an expensive pathology, whose costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million in health insurance in France.
Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond/recover from acute UFF-related stress. Physical resilience is an emerging concept in medicine, which defines the dynamic ability of a subject to resist or recover from a functional decline due to stress or disruption. In this context, developing new approaches to assess resilience is important, to take into account each patient's specific resilience in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to identify, in older patients after a UFF intervention, the muscle signature associated with good functional recovery (= physical resilience). The objective of the investigators is to identify the parameters derived from high definition surface electromyography (HD-sEMG) by developing software that will provide this muscle signature. This technology is innovative, non-invasive and portable, and already CE marked.
Main objective: to identify HD-sEMG parameters, measured during quadriceps extension of the lower limb not affected by surgery, within 7 days post surgery for UFF, associated with functional status without human assistance (SPPB) at day 30.
Main Evaluation Criterion: To investigate the association between the parameters provided by HD-sEMG (32 simultaneous channels; portable device and software, Mobita®) of the rectus femoris and functional status without human assistance measured by the Short Physical Performance Battery (SPPB = walking speed over 4 meters, chair satnds, balance) at 30 days after surgery for FESF.
Secondary objectives: to study the association between parameters from HD-sEMG measured during quadriceps extension of the lower limb not affected by surgery within 7 days post surgery for FESF and :
Secondary evaluation criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High definition surface electromyography (HD-sEMG) | Device | HD-sEMG data will be collected by Mobita 32® (TMSi) device |
| Measure | Description | Time Frame |
|---|---|---|
| HD-sEMG correlated to SPPB | Identify HD-sEMG parameters and mesured them during quadriceps muscle extension on lower limb not affected by surgery in the 7th days after UFF surgery, associated to functional status without human assistance (SPPB) at Day 30. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Walking ability at Day 30 | 3 possible answers: autonom walk=2, with technical assistance=1, impossible=0 a higher score meaning better outcome min value=0, maximum value=2 | Day 30 |
| Patient autonomy at Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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Older patients aged 70 years old and over, hospitalized in orthogeriatics after upper femoral fracture surgery.
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| Name | Affiliation | Role |
|---|---|---|
| KIYOKA KINUGAWA, MD, PhD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP - Charles Foix Hospital | Ivry-sur-Seine | 94200 | France | |||
| APHP - Rotschild |
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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Activities of Daily Living scale (ADL scale) a hiigher score meaning better outcome min value=0, maximum value=6
| Day 30 |
| 5 meters Walking speed at Day 30 | Time measurement, in second, to walk 5 meters | Day 30 |
| Quality of life at Day 30: European Quality of Life-5 Dimensions questionnaire | European Quality of Life-5 Dimensions (EQ5D questionnaire) a lower score meaning better outcome min value=0, maximum value=20 | Day 30 |
| HD-sEMG parameters at Day 30 | High density surface electromyogram signals obtained from rectus femoris muscle:
| Day 30 |
| Intra hospital Mortality | Number of patient death during hospital stay | Day 30 |
| Rehospitalization delay | days between end of first hospitalization and begining of rehospitalization | Day 30 |
| Length of stay in rehabilitation care and Orthogeriatric sector | Mean Length of stay | Day 30 |
| Paris |
| Île-de-France Region |
| 75012 |
| France |
| APHP - Saint-Antoine Hospital | Paris | Île-de-France Region | 75012 | France |
| APHP - Pitie Salpetriere Hospital - UPOG | Paris | Île-de-France Region | 75013 | France |
| D007869 |
| Leg Injuries |