Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-22 @ 2:32 AM
Study NCT ID:
NCT06430567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012783', 'term': 'Shoulder Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants between placebo and intervention group will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isokinetic strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Concentric peak torque (Nm) IR-ER at 60°/sec'}, {'measure': 'Isokinetic strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Concentric peak torque (Nm) IR-ER at 240°/sec'}, {'measure': 'Isokinetic strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Eccentric peak torque (Nm) IR-ER at 60°/sec'}, {'measure': 'Isokinetic strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Concentric ratio (ER conc 60°/ IR conc 60°)'}, {'measure': 'Isokinetic strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Cocking gesture ratio (IR exc 60° /ER conc 240°)'}, {'measure': 'Isometric strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Flexion in the scapular plane (Nm)'}, {'measure': 'Isometric strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Athletic shoulder test (positions I, Y, T) (Nm)'}, {'measure': 'Isometric strength', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Grip test (Nm)'}], 'secondaryOutcomes': [{'measure': 'Shoulder mobility', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Flexion'}, {'measure': 'Shoulder mobility', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Abduction'}, {'measure': 'Shoulder mobility', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Internal rotation at 90° abduction'}, {'measure': 'Shoulder mobility', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'External rotation at 90° abduction'}, {'measure': 'Shoulder mobility', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Scapular dyskinesis test (SDT)'}, {'measure': 'Scapular girdle stability', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Modified closed kinetic upper extremity stability test'}, {'measure': 'Scapular girdle stability', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Shoulder Instability Return to Sport Index (SIRSI)'}, {'measure': 'Scapular girdle stability', 'timeFrame': 'Preoperative and at 14 weeks postoperative', 'description': 'Western Ontario Shoulder Instability Index (WOSI)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood flow restriction', 'Latarjet surgery', 'Rehabilitation'], 'conditions': ['Shoulder Dislocation']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\nDoes BFR training improve scapular belt muscle strength post-surgery? Does BFR training enhance shoulder function during rehabilitation?\n\nResearchers will compare three groups:\n\nBFR Group with 50% AOP \\[arterial occlusion pressure\\] compression BFR Placebo Group with 10% AOP compression Control Group\n\nParticipants will:\n\nPerform 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-35 years\n* 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).\n* Regular exercise (min. 1x / week)\n* Signed the informed consent form for the study.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Active oncological disease under treatment. (Patient with stable oncological disease eligible)\n* 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\n* History of deep vein thrombosis/pulmonary embolism\n* Inability to follow study procedures, due to language problems, psychological disorders, dementia.\n* Need for skin grafting following shoulder stabilization surgery\n* Coronary heart disease\n* Unstable hypertension\n* Peripheral vascular disease\n* Hypercoagulable states (blood coagulation disorders)\n* Left ventricular dysfunction\n* Hemophilia'}, 'identificationModule': {'nctId': 'NCT06430567', 'acronym': 'BFR', 'briefTitle': 'Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Ensemble Hospitalier de la Côte'}, 'officialTitle': 'Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure', 'orgStudyIdInfo': {'id': 'EHC Morges BFR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patient will not use BFR'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 10% of pressure for arterial occlusion', 'description': 'Patient will use BFR sub optimally as described in the literature', 'interventionNames': ['Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability']}, {'type': 'EXPERIMENTAL', 'label': 'Interventional 50% of pressure for arterial occlusion', 'description': 'Patient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature', 'interventionNames': ['Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability']}], 'interventions': [{'name': 'Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability', 'type': 'DEVICE', 'description': '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:\n\nGroup 1) BFR Group with 50% AOP compression\n\nGroup 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)\n\nExercise :\n\nExternal rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band\n\nBFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.', 'armGroupLabels': ['Interventional 50% of pressure for arterial occlusion']}, {'name': 'Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability', 'type': 'DEVICE', 'description': '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:\n\nGroup 2) BFR Group with 10% AOP compression\n\nGroup 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\n\nExercise :\n\nExternal rotation with pulley/band Internal rotation with pulley/band Frontal elevation with hyperpronation Diagonal abduction-external rotation with pulley/band\n\nBFR training will use the MadUp© system, placing the band proximally on the operated arm, with a central unit continuously monitoring and calibrating arm pressure.', 'armGroupLabels': ['Placebo 10% of pressure for arterial occlusion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bauer Stefan, MD', 'role': 'CONTACT', 'email': 'stefan.bauer@ehc.vd.ch', 'phone': '0787105993', 'phoneExt': '+41'}, {'name': 'Arnaud Meylan, MD', 'role': 'CONTACT', 'email': 'arnaud.meylan@icloud.com', 'phone': '0792092956', 'phoneExt': '+41'}], 'overallOfficials': [{'name': 'Bauer Stefan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EHC Morges'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ensemble Hospitalier de la Côte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Arnaud Meylan', 'investigatorAffiliation': 'Ensemble Hospitalier de la Côte'}}}}