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Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06430567
Acronym
BFR
Enrollment
50
Registered
2024-05-28
Start date
2024-06-10
Completion date
2027-06-30
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

Keywords

Blood flow restriction, Latarjet surgery, Rehabilitation

Brief 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.

Interventions

DEVICEBlood 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 30-15-15-15 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.

DEVICEBlood 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 15-15-15-15 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.

Sponsors

Ensemble Hospitalier de la Côte
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants between placebo and intervention group will be blinded

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Isokinetic strengthPreoperative and at 14 weeks postoperativeConcentric peak torque (Nm) IR-ER at 60°/sec
Isometric strengthPreoperative and at 14 weeks postoperativeFlexion in the scapular plane (Nm)

Secondary

MeasureTime frameDescription
Shoulder mobilityPreoperative and at 14 weeks postoperativeFlexion
Scapular girdle stabilityPreoperative and at 14 weeks postoperativeModified closed kinetic upper extremity stability test

Contacts

Primary ContactBauer Stefan, MD
stefan.bauer@ehc.vd.ch0787105993
Backup ContactArnaud Meylan, MD
arnaud.meylan@icloud.com0792092956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026