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Not yet recruiting NCT06430567

Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

No phase Interventional Shoulder Dislocation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability, Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability.
Who it may be relevant to
Registry conditions: Shoulder Dislocation. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure

Overview

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.

Interventions

  • Device Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
    Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up: Group 1) BFR Group with 50% AOP compression Group 1 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 30
  • Device Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
    Participants undergoing shoulder instability surgery (Latarjet procedure) by a single surgeon will receive standard physiotherapy (2 sessions per week) before being randomized into 3 groups at their 6th postoperative week check-up: Group 2) BFR Group with 10% AOP compression Group 2 will perform a 30-minute strengthening session twice weekly during postoperative weeks 7 to 14. They will do 4 exercises, completing 4 sets with 30-second rest intervals and 1 minute between exercises, following 15

Primary outcome measures

  • Isokinetic strength [Time frame: Preoperative and at 14 weeks postoperative]
  • Isokinetic strength [Time frame: Preoperative and at 14 weeks postoperative]
  • Isokinetic strength [Time frame: Preoperative and at 14 weeks postoperative]
  • Isokinetic strength [Time frame: Preoperative and at 14 weeks postoperative]
  • Isokinetic strength [Time frame: Preoperative and at 14 weeks postoperative]
  • Isometric strength [Time frame: Preoperative and at 14 weeks postoperative]
  • Isometric strength [Time frame: Preoperative and at 14 weeks postoperative]
  • Isometric strength [Time frame: Preoperative and at 14 weeks postoperative]
Secondary outcome measures (8)
  • Shoulder mobility [Time frame: Preoperative and at 14 weeks postoperative]
  • Shoulder mobility [Time frame: Preoperative and at 14 weeks postoperative]
  • Shoulder mobility [Time frame: Preoperative and at 14 weeks postoperative]
  • Shoulder mobility [Time frame: Preoperative and at 14 weeks postoperative]
  • Shoulder mobility [Time frame: Preoperative and at 14 weeks postoperative]
  • Scapular girdle stability [Time frame: Preoperative and at 14 weeks postoperative]
  • Scapular girdle stability [Time frame: Preoperative and at 14 weeks postoperative]
  • Scapular girdle stability [Time frame: Preoperative and at 14 weeks postoperative]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06430567 · EHC Morges BFR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗