Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure (NCT06430567) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure
50 participantsStarted 2024-06-10
Plain-language summary
The goal of this clinical trial is to evaluate the effects of Blood Flow Restriction (BFR) training on post-surgery rehabilitation following the Latarjet procedure in athletes aged 18-35.
The main questions it aims to answer are:
Does BFR training improve scapular belt muscle strength post-surgery? Does BFR training enhance shoulder function during rehabilitation?
Researchers will compare three groups:
BFR Group with 50% AOP \[arterial occlusion pressure\] compression BFR Placebo Group with 10% AOP compression Control Group
Participants will:
Perform the same four strengthening exercises twice a week Complete 16 semi-autonomous strength training sessions over 8 weeks Undergo isokinetic and isometric strength tests, shoulder mobility assessments, and complete self-assessment questionnaires.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18-35 years
* Indication for shoulder stabilization surgery using the Latarjet procedure (documented anterior dislocations with proof of emergency reduction, with or without hypermobility and confirmation of traumatic capsulo-ligamentous injury by MRI).
* Regular exercise (min. 1x / week)
* Signed the informed consent form for the study.
Exclusion Criteria:
* Pregnant or breast-feeding women
* Active oncological disease under treatment. (Patient with stable oncological disease eligible)
* Adverse events during the 6-week post-operative period such as:-Fracture/displacement of the reconstructed bone-Luxation of the operated shoulder-Requirement for emergency hospitalization
* History of deep vein thrombosis/pulmonary embolism
* Inability to follow study procedures, due to language problems, psychological disorders, dementia.
* Need for skin grafting following shoulder stabilization surgery
* Coronary heart disease
* Unstable hypertension
* Peripheral vascular disease
* Hypercoagulable states (blood coagulation disorders)
* Left ventricular dysfunction
* Hemophilia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Isokinetic strength
Timeframe: Preoperative and at 14 weeks postoperative
2
Isokinetic strength
Timeframe: Preoperative and at 14 weeks postoperative
3
Isokinetic strength
Timeframe: Preoperative and at 14 weeks postoperative
4
Isokinetic strength
Timeframe: Preoperative and at 14 weeks postoperative
5
Isokinetic strength
Timeframe: Preoperative and at 14 weeks postoperative
6
Isometric strength
Timeframe: Preoperative and at 14 weeks postoperative
7
Isometric strength
Timeframe: Preoperative and at 14 weeks postoperative