Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

Shoulder Dislocation Clinical Trial

— BFR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430567
• Other study ID #: EHC Morges BFR
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: Ensemble Hospitalier de la Côte
• Contact: Bauer Stefan, MD
• Phone: 0787105993
• Email: stefan.bauer[@]ehc.vd.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

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 30-15-15-15 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ensemble Hospitalier de la Côte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isokinetic strength	Concentric peak torque (Nm) IR-ER at 60°/sec	Preoperative and at 14 weeks postoperative
Primary	Isokinetic strength	Concentric peak torque (Nm) IR-ER at 240°/sec	Preoperative and at 14 weeks postoperative
Primary	Isokinetic strength	Eccentric peak torque (Nm) IR-ER at 60°/sec	Preoperative and at 14 weeks postoperative
Primary	Isokinetic strength	Concentric ratio (ER conc 60°/ IR conc 60°)	Preoperative and at 14 weeks postoperative
Primary	Isokinetic strength	Cocking gesture ratio (IR exc 60° /ER conc 240°)	Preoperative and at 14 weeks postoperative
Primary	Isometric strength	Flexion in the scapular plane (Nm)	Preoperative and at 14 weeks postoperative
Primary	Isometric strength	Athletic shoulder test (positions I, Y, T) (Nm)	Preoperative and at 14 weeks postoperative
Primary	Isometric strength	Grip test (Nm)	Preoperative and at 14 weeks postoperative
Secondary	Shoulder mobility	Flexion	Preoperative and at 14 weeks postoperative
Secondary	Shoulder mobility	Abduction	Preoperative and at 14 weeks postoperative
Secondary	Shoulder mobility	Internal rotation at 90° abduction	Preoperative and at 14 weeks postoperative
Secondary	Shoulder mobility	External rotation at 90° abduction	Preoperative and at 14 weeks postoperative
Secondary	Shoulder mobility	Scapular dyskinesis test (SDT)	Preoperative and at 14 weeks postoperative
Secondary	Scapular girdle stability	Modified closed kinetic upper extremity stability test	Preoperative and at 14 weeks postoperative
Secondary	Scapular girdle stability	Shoulder Instability Return to Sport Index (SIRSI)	Preoperative and at 14 weeks postoperative
Secondary	Scapular girdle stability	Western Ontario Shoulder Instability Index (WOSI)	Preoperative and at 14 weeks postoperative