Adding local muscle vibration to rehabilitation for older adults after hip fracture
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
This project will test whether adding local muscle vibration to standard rehabilitation helps people aged 75 and older recover after hip fracture surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT07309965 on ClinicalTrials.gov |
What this trial studies
This interventional study will combine a standard rehabilitation program with sessions of localized muscle vibration in patients aged 75 and over who have had surgery for an upper femur fracture. Participants admitted to the geriatric rehabilitation unit within 14 days of their operation will receive an initial assessment, the combined intervention during their stay, and a final assessment plus an acceptability and satisfaction questionnaire. The protocol allows inclusion of patients able to consent and, under defined procedures, patients with impaired capacity through surrogate or guardian consent. Outcomes will target feasibility, functional recovery measures, and patient acceptability of the vibration adjunct.
Who should consider this trial
Good fit: Ideal candidates are patients aged 75 or older who underwent surgical repair of an upper femur fracture and are admitted to geriatric rehabilitation within 14 days of surgery.
Not a fit: Patients who are legally detained, have severe psycho-behavioral disturbances, or have contraindications to local vibration are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, adding local vibration could improve mobility and reduce functional decline after hip fracture in older adults.
How similar studies have performed: Localized muscle vibration has shown neuromuscular benefits in healthy people and some rehab contexts, but its use specifically after hip fracture in very elderly patients remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lyon
- HOPITAL PIERRE GARRAUD - Service de MEDECINE GERIATRIQUE — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Alexandre MENDIBIL, MD
- Email: alexandre.mendibil@chu-lyon.fr
- Phone: 00 33 4 72 16 71 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.