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

February 5, 2026 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69005
        • Recruiting
        • HOPITAL PIERRE GARRAUD - Service de MEDECINE GERIATRIQUE
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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 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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of implementing local muscle vibration sessions
Time Frame: 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.
Week 4 : End of standard rehabilitation protocol plus local vibrations

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of eligible patients not taking part in the study
Time Frame: Week 4 : End of standard rehabilitation protocol plus local vibrations
Number of eligible patients not participating in the study and description of reasons
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
Description of the reasons why sessions were not carried out (less than 5 sessions) and why sessions were not carried out in full (less than 30 min) over 4 weeks of rehabilitation using a local vibration session traceability sheet.
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
Description of the effects noted during the local vibration sessions (redness, heat, pain or other discomfort) using the local vibration session traceability form.
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

Isometric force differential (measured by the physiotherapist using a dynamometer).This differential (in %) is defined by the following equation:

(FIM injured limb (T1) - FIM non-injured limb (T0)) / FIM non-injured limb (T0)
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

• Clinically significant improvement in physical performance between the start of rehabilitation and after 4 weeks of the rehabilitation programme.

Physical performance was assessed by the overall score of the SPPB (Short Physical Performance Battery), based on three components: walking speed, chair raising and balance tests. A global score of 0 to 6 is a low performance score, a global score of 7 to 9 is an intermediate performance score and a global score of 10 to 12 is a high performance score. An improvement will be considered clinically significant for patients who change performance group positively.
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

A clinically significant reduction in the risk of falling between the start of rehabilitation and after 4 weeks of the rehabilitation programme.

This risk of falling is assessed by the TINETTI score. A score of less than 20 points is a very high fall risk score, a score of 20 to 23 points is a high fall risk score and a score of 24 to 28 points is a low fall risk score. An improvement will be considered clinically significant for patients who change fall risk group positively.
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

Difference between the score obtained for transfers between the start of rehabilitation and after 4 weeks of the rehabilitation programme.

Each type of transfer (lying>seated, sitting>standing, bed>chair) will be scored as follows 0: no assistance, 0.5: partial material and/or human assistance, 1: total assistance, 2: not feasible. These sub-scores will be added together to obtain an overall transfer score.
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

Difference in pain score between the start of rehabilitation and 4 weeks after the rehabilitation programme.

Pain was assessed using a simple verbal scale (0: Absent, 1: Mild, 2: Moderate, 3: Intense, 4: Unbearable).
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
Evaluation scale (5-point Likert scale) measuring the patient's perception of the use of local vibration in their rehabilitation programme (comfort and ease of use, perceived effectiveness, and overall satisfaction). Collection of points for improvement. The higher the score, the more the patient agrees.
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
Evaluation scale (5-point Likert scale) measuring nursing staff's perception of the use of local vibration in a rehabilitation programme (experience of use, ease of integration into practice, safety and tolerance, overall satisfaction). Collection of points for improvement. The higher the score, the more the patient agrees.
At 8 weeks - End of protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL24_1080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Elderly

Clinical Trials on Initial Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings