Feasibility of Integrating Local Vibration Into Rehabilitation of Elderly Patients After Hip Fracture

NCT07309965 | Recruiting

• 1 other identifier: 69HCL24_1080
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Fracture Femur

Keywords

Rehabilitation; Fracture of the upper end of the femur; Local muscle vibration; Geriatrics

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing local muscle vibration sessions

  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.

  Week 4 : End of standard rehabilitation protocol plus local vibrations

Secondary Outcomes (10)

• Number of eligible patients not taking part in the study

  Week 4 : End of standard rehabilitation protocol plus local vibrations

• Reasons for not completing sessions and incomplete completion of sessions

  Week 4 : End of standard rehabilitation protocol plus local vibrations

• Tolerability of the muscle vibration technique in real-life care conditions

  Week 4 : End of standard rehabilitation protocol plus local vibrations

• Results after the local muscle vibration technique in terms of variation between the start of rehabilitation and after 4 weeks in following parameters: • Isometric strength (in %)

  Week 4 : End of standard rehabilitation protocol plus local vibrations

• Results after the local muscle vibration technique in terms of variation between the start of rehabilitation and after 4 weeks of the rehabilitation programme in the following parameters: • Physical performance

  At 4 weeks - End of standard rehabilitation protocol plus local vibrations

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

Initial Assessment DIAGNOSTIC_TEST

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)

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

Standard rehabilitation programme combined with local vibration sessions DEVICE

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.

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

Final assessment OTHER

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).

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

Acceptability and satisfaction questionnaire OTHER

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.

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

HOPITAL PIERRE GARRAUD - Service de MEDECINE GERIATRIQUE

Lyon, 69005, France

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Alexandre MENDIBIL, MD

CONTACT

00 33 4 72 16 71 39; alexandre.mendibil@chu-lyon.fr

Stéphanie TRIPOZ DIT MASSON

CONTACT

00 33 4 78 86 32 92; stephanie.tripoz-dit-masson@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-centre, prospective feasibility study

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 30, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 19, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-12

Locations

FR (1)