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

Official title

Feasibility Study on the Implementation of Local Muscle Vibration as Part of a Rehabilitation Program for Elderly Patients Following Fracture of the Upper End of the Femur

Overview

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.

Interventions

• Diagnostic test 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 Ba
• Device 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.
• Other 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).
• Other 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.

Primary outcome measures

• Feasibility of implementing local muscle vibration sessions [Time frame: Week 4 : End of standard rehabilitation protocol plus local vibrations]

Secondary outcome measures (10)

• Number of eligible patients not taking part in the study [Time frame: Week 4 : End of standard rehabilitation protocol plus local vibrations]
• Reasons for not completing sessions and incomplete completion of sessions [Time frame: Week 4 : End of standard rehabilitation protocol plus local vibrations]
• Tolerability of the muscle vibration technique in real-life care conditions [Time frame: 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 %) [Time frame: 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 [Time frame: At 4 weeks - End of standard rehabilitation protocol plus local vibrations]
• Evaluate the 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: • Risk of falling [Time frame: At 4 weeks - 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: • Transfers [Time frame: At 4 weeks - End of standard rehabilitation protocol plus local vibrations]
• Evaluate the 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: • Pain [Time frame: At 4 weeks - End of standard rehabilitation protocol plus local vibrations]
• Measure patients' perceptions of the use of local muscle vibration in their rehabilitation protocol [Time frame: At 8 weeks - End of protocol]
• Measure the perception of healthcare professionals in the field regarding the use of local muscle vibration as part of their current functional rehabilitation protocol. [Time frame: At 8 weeks - End of protocol]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• HOPITAL PIERRE GARRAUD - Service de MEDECINE GERIATRIQUE — Lyon

Identifiers

NCT: NCT07309965 · 69HCL24_1080

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗