NCT07309965 Feasibility of Integrating Local Vibration Into Rehabilitation of Elderly Patients After Hip Fracture
| NCT ID | NCT07309965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Fracture Femur |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2026-11-19 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-11-19 with a primary completion date of 2026-11-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fractures of the upper end of the femur in elderly patients are the 2nd most common fracture. A fracture leads to a syndrome of psychomotor maladjustment, encouraged by pain and aggravated by hospitalisation. In 2014, 50,000 women and 16,000 men suffered this type of fracture every year. The consequences are serious, with a one-year mortality rate of 20 to 24% and an institutionalisation rate of 25%. In 2015, the direct cost of hip fracture in France was estimated at around €1 billion. In line with the recommendations of the National Institute for Health and Care Excellence (NICE) and the results of meta-analyses, it is recommended that, in the absence of surgical or medical contraindications, patients should be assessed within 24 hours of hip fracture surgery, with a view to initiating early mobilisation and multidisciplinary rehabilitation. It has been shown in healthy subjects that prolonged application of localised vibrations optimises nerve capacity, leading to an increase in maximum voluntary force. For population of frail elderly post-operative patients, this localised vibration technique could accelerate and improve functional recovery, particularly in terms of muscle strength, joint mobility and pain. A reduction in muscle loss is hoped for, with benefits in terms of tolerance compared with neurostimulation. As part of the implementation of the above-mentioned recommendations, the investigators wish to assess the quality of the integration of this technique, already in use in the department on an ad hoc basis, into the organisation of the department and of the patient's care pathway as a complement to the rehabilitation protocols, by identifying the obstacles and facilitating factors. The study will also provide the first estimates of the effect on muscle recovery. The investigator hypothesise that this local vibration protocol can be integrated into the rehabilitation department's work schedule and into the patient's care pathway, and that it will be acceptable to both the patient and the nursing staff.
Eligibility Criteria
Inclusion Criteria: * Patients aged 75 or over who have undergone surgery for a fracture of the upper end of the femur * Hospitalised in the SMR department no later than D14 of their operation * Resource Iso Group greater than or equal to 3 on the Aggir scale * Patient capable of consenting who has signed a consent form or patient unable to express consent at the discretion of the principal investigator, informed and not opposed to the study, for whom a trusted person, or if not available, the family, or if not available, a close relative has signed an informed consent within a maximum of 2 days. For patients under guardianship, the guardian's consent will be requested, and for patients under curatorship, the patient will sign the consent in the presence of the curator within a maximum of 2 days as well. * Affiliated to a social security scheme Exclusion Criteria: * Persons deprived of their liberty by a judicial or administrative decision * Individuals with severe psycho-behavioral disorders (major psychiatric or neurocognitive disorders) * Persons admitted to a health or social establishment for purposes other than research * Contraindications to electrical stimulation: * Patient with active devices such as pacemakers, defibrillators, insulin pumps, neurostimulators, etc * Patient with phlebitis or risk of thrombosis * Epileptic patient * Patient with fragile skin or open wounds on the lower limbs * Subject participating in another interventional study with an exclusion period still in progress at pre-inclusion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07309965 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Fracture Femur. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309965 currently recruiting?
Yes, NCT07309965 is actively recruiting participants. Contact the research team at alexandre.mendibil@chu-lyon.fr for enrollment information.
Where is the NCT07309965 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT07309965 clinical trial?
NCT07309965 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 25 participants.