Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorEnsemble Hospitalier de la Côte

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability

    Device

    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 30-15-15-15 at 40% 1RM (repetition maximum) Exercise : External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.

  • Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability

    Device

    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 15-15-15-15 at 70% 1RM Exercise : External rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band BFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Placebo 10% of pressure for arterial occlusionPlacebo comparator 1 intervention
Group C: Interventional 50% of pressure for arterial occlusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Isokinetic strength

Concentric peak torque (Nm) IR-ER at 60°/sec

Time frame
Preoperative and at 14 weeks postoperative
2

Isokinetic strength

Concentric peak torque (Nm) IR-ER at 240°/sec

Time frame
Preoperative and at 14 weeks postoperative
3

Isokinetic strength

Eccentric peak torque (Nm) IR-ER at 60°/sec

Time frame
Preoperative and at 14 weeks postoperative
4

Isokinetic strength

Concentric ratio (ER conc 60°/ IR conc 60°)

Time frame
Preoperative and at 14 weeks postoperative

Secondary outcomes

1

Shoulder mobility

Flexion

Time frame
Preoperative and at 14 weeks postoperative
2

Shoulder mobility

Abduction

Time frame
Preoperative and at 14 weeks postoperative
3

Shoulder mobility

Internal rotation at 90° abduction

Time frame
Preoperative and at 14 weeks postoperative
4

Shoulder mobility

External rotation at 90° abduction

Time frame
Preoperative and at 14 weeks postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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