Feasibility of Integrating Local Vibration Into Rehabilitation of Elderly Patients After Hip Fracture
NCT ID: NCT07309965
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-11-19
2026-12-19
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subjects aged 75 and over with surgery following a fracture of the upper end of the femur
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
75 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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HOPITAL PIERRE GARRAUD - Service de MEDECINE GERIATRIQUE
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Alexandre MENDIBIL, MD
Role: primary
Other Identifiers
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69HCL24_1080
Identifier Type: -
Identifier Source: org_study_id