Status:
COMPLETED
Clinical Validation of a Mobility Monitor to Measure and Predict Health Outcomes
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Hip Fractures
Eligibility:
All Genders
45+ years
Brief Summary
Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mob...
Detailed Description
The study plans to include patients in two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy, it is po...
Eligibility Criteria
Inclusion
- Aged 45 or over
- Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery
- be able to walk 4 meters
- .be available for 24 months following the fracture,
- be able to read and understand the briefing note and complete questionnaires feedback
- express their will and sign a consent to participate in follow-up testing, and to wear the motion sensor
- The patient must be a member or beneficiary of a health insurance plan
Exclusion
- Occurrence of one of the following events in the 3 months preceding the consent enlightened
- subject with a history of myocardial infarction,
- Subject hospitalized for unstable angina,
- Subject with a history of stroke,
- Subject with a history of coronary bypass surgery (PAC),
- Subject having had percutaneous coronary intervention (PCI),
- Subject having had a cardiac resynchronization therapy device implanted (CRTD),
- \- Other criteria for non-inclusions
- Subject with active treatment for cancer or other malignant disease,
- Subject with uncontrolled congestive heart disease (NYHA class\> 3),
- Subject with acute psychosis or major psychiatric disorders
- Subject with continued drug addiction.
- Subject unable to walk prior to hip fracture treatment.
- The patient is participating in another interventional category I study,
- l All categories of persons particularly protected under the law French (adults under guardianship, guardianship or safeguard of justice…. articles L1121-8 - L1121-5 - L1121-6 - L1121-7 - L1121-9 of the Health Code Public)
Key Trial Info
Start Date :
October 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 4 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04911231
Start Date
October 4 2021
End Date
March 4 2024
Last Update
August 15 2024
Active Locations (2)
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1
Polyclinique Saint-Roch
Montpellier, France, 34000
2
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295