Feasibility of Integrating Local Vibration Into Rehabilitation of Elderly Patients After Hip Fracture
Condition(s) studied
Investigational drug(s) / intervention(s)
Initial Assessment: Upon entering the SMR service, the patient receives several evaluations from the nurse. * a functional assessment : * Basic ADLs (BADLs) 6-point score * Instrumental ADLs (IADLs) 8-point score * a frailty assessment * a nutritional assessment * Body Mass Index (BMI) * Bioelectrical Impedance Analysis * JAMAR Grip Strength Test * A measurement of the maximum isometric strength of the non-injured limb (T0) * An assessment of physical performance using the Short Physical Performance Battery (SPPB) * An assessment of the risk of falling using TINETTI It has two subscales: * Balance section (maximum 16 points) Assesses sitting balance, sit-to-stand, standing balance, response to mild pushes, turning, etc. * Gait section (maximum 12 points) - Pain assessment using a simple verbal scale (EVS)
Standard rehabilitation programme combined with local vibration sessions: The patient will receive a standard rehabilitation programme combined with local vibration sessions 5 times a week for 30 minutes each for 4 weeks. A record of these sessions will be completed every day by the rehabilitation specialist.
Final assessment: The patient will undergo the same tests as the initial assessment, with the addition of a measurement of the isometric force on the injured limb (T1).
Acceptability and satisfaction questionnaire: An acceptability and satisfaction questionnaire will be given to all the paramedical teams and patients who took part in the study in order to assess the potential constraints linked to the implementation.
Study 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
Primary outcome measure(s)
- Feasibility of implementing local muscle vibration sessions — Week 4 : End of standard rehabilitation protocol plus local vibrations
Completion of local muscle vibration sessions. The operation will be considered complete if 5 sessions lasting 30 minutes per week have been carried out for 4 weeks.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| HOPITAL PIERRE GARRAUD - Service de MEDECINE GERIATRIQUE | Lyon | France | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07309965 on ClinicalTrials.gov ↗ ← All trials in France