Fracture FemurORTHOBOOSTER-PNCT07309965
Feasibility of Integrating Local Vibration Into Rehabilitation of Elderly Patients After Hip Fracture
A study testing Initial Assessment, Standard rehabilitation programme combined with local vibration sessions and Final assessment in people with Fracture Femur and Elderly, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Fracture Femur, Elderly
- What is being tested?
- Initial Assessment, Standard rehabilitation programme combined with local vibration sessions and Final assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2025to 19 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stéphanie TRIPOZ DIT MASSON contact
France1 site, 1 recruiting
- Recruiting
HOPITAL PIERRE GARRAUD - Service de MEDECINE GERIATRIQUE
Lyon, 69005
Alexandre MENDIBIL, MD, 00 33 4 72 16 71 39 ext. +33, alexandre.mendibil@chu-lyon.fr
About this study
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
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.
Read more
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
- Fracture Femur, Elderly
- Being tested
- Initial Assessment, Standard rehabilitation programme combined with local vibration sessions, Final assessment, Acceptability and satisfaction questionnaire
- Keywords
- Rehabilitation, Fracture of the upper end of the femur, Local muscle vibration, Geriatrics
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial AssessmentDiagnostic 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)
Standard rehabilitation programme combined with local vibration sessionsDevice
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 assessmentOther
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 questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Initial Assessment; Device: Standard rehabilitation programme combined with local vibration sessions; Other: Final assessment; Other: Acceptability and satisfaction questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4 : End of standard rehabilitation protocol plus local vibrations
Secondary outcomes (10)
Number of eligible patients not taking part in the study
Number of eligible patients not participating in the study and description of reasons
Measured: Week 4 : End of standard rehabilitation protocol plus local vibrations
Reasons for not completing sessions and incomplete completion of sessions
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.
Measured: Week 4 : End of standard rehabilitation protocol plus local vibrations
Tolerability of the muscle vibration technique in real-life care conditions
Description of the effects noted during the local vibration sessions (redness, heat, pain or other discomfort) using the local vibration session traceability form.
Measured: 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 %)
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)
Measured: 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
- 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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.
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.
Measured: At 8 weeks - End of protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start19 Nov 2025
- Primary completion19 Nov 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture FemurStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-centre, prospective feasibility study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309965
- Sponsor's protocol ID
- 69HCL24_1080
- Acronym
- ORTHOBOOSTER-P
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07309965
- Acronym / sponsor ID
- ORTHOBOOSTER-P / 69HCL24_1080
- Conditions
- Fracture Femur, Elderly
- Keywords
- Rehabilitation, Fracture of the upper end of the femur, Local muscle vibration, Geriatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-centre, prospective feasibility study
| Arm | Type | Receives |
|---|---|---|
| Subjects aged 75 and over with surgery following a fracture of the upper end of the femur | Experimental | Diagnostic Test: Initial Assessment, Device: Standard rehabilitation programme combined with local vibration sessions, Other: Final assessment, Other: Acceptability and satisfaction questionnairePatient, 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 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
- Subject participating in another interventional study with an exclusion period still in progress at pre-inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial AssessmentUpon 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) | Diagnostic test | Subjects aged 75 and over with surgery following a fracture of the upper end of the femur |
| Standard rehabilitation programme combined with local vibration sessionsThe 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. | Device | Subjects aged 75 and over with surgery following a fracture of the upper end of the femur |
| Final assessmentThe 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 | Subjects aged 75 and over with surgery following a fracture of the upper end of the femur |
| Acceptability and satisfaction questionnaireAn 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. | Other | Subjects aged 75 and over with surgery following a fracture of the upper end of the femur |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie TRIPOZ DIT MASSON contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Assessment, Standard rehabilitation programme combined with local vibration sessions and Final assessment in people with Fracture Femur and Elderly, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre MENDIBIL, MD (00 33 4 72 16 71 39 ext. +33, alexandre.mendibil@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing local muscle vibration sessions (time frame: Week 4 : End of standard rehabilitation protocol plus local vibrations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.