An interventional study of Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability and Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability in Shoulder Dislocation, sponsored by Ensemble Hospitalier de la Côte. Not yet recruiting. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Ensemble Hospitalier de la Côte · Not applicable, Interventional, and Treatment
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.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →Ensemble Hospitalier de la Côte is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will not use BFR
Patient will use BFR sub optimally as described in the literature
Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
Patient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature
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.
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.
Isokinetic strength
Concentric peak torque (Nm) IR-ER at 60°/sec
Time frame: Preoperative and at 14 weeks postoperative
Isokinetic strength
Concentric peak torque (Nm) IR-ER at 240°/sec
Time frame: Preoperative and at 14 weeks postoperative
Isokinetic strength
Eccentric peak torque (Nm) IR-ER at 60°/sec
Time frame: Preoperative and at 14 weeks postoperative
Isokinetic strength
Concentric ratio (ER conc 60°/ IR conc 60°)
Time frame: Preoperative and at 14 weeks postoperative
Isokinetic strength
Cocking gesture ratio (IR exc 60° /ER conc 240°)
Time frame: Preoperative and at 14 weeks postoperative
Isometric strength
Flexion in the scapular plane (Nm)
Time frame: Preoperative and at 14 weeks postoperative
Isometric strength
Athletic shoulder test (positions I, Y, T) (Nm)
Time frame: Preoperative and at 14 weeks postoperative
Isometric strength
Grip test (Nm)
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Flexion
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Abduction
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Internal rotation at 90° abduction
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
External rotation at 90° abduction
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Scapular dyskinesis test (SDT)
Time frame: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Modified closed kinetic upper extremity stability test
Time frame: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Shoulder Instability Return to Sport Index (SIRSI)
Time frame: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Western Ontario Shoulder Instability Index (WOSI)
Time frame: Preoperative and at 14 weeks postoperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Ensemble Hospitalier de la Côte