Feasibility of Integrating Local Vibration Into Rehabilitation of Elderly Patients After Hip Fracture (ORTHOBOOSTER-P)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Elderly; Fracture Femur

Treatments: Diagnostic Test: Initial Assessment; Other: Final assessment; Other: Acceptability and satisfaction questionnaire; Device: Standard rehabilitation programme combined with local vibration sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT07309965

69HCL24_1080

Details and patient eligibility

About

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, we 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Subjects aged 75 and over with surgery following a fracture of the upper end of the femur

Experimental group

Description:

Patient, aged 75 and over, hospitalised in Medical and Rehabilitation Care no later than D14 of his operation for a fracture of the upper end of the femur

Treatment:

Device: Standard rehabilitation programme combined with local vibration sessions

Other: Acceptability and satisfaction questionnaire

Other: Final assessment

Diagnostic Test: Initial Assessment