Shoulder DislocationBFRNCT06430567
Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure
A study testing 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 people with Shoulder Dislocation, run by Ensemble Hospitalier de la Côte.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Coronary heart disease
- Unstable hypertension
- Peripheral vascular disease
- Hypercoagulable states (blood coagulation disorders)
- Left ventricular dysfunction
- Hemophilia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure
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:
Read more
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.
- Conditions
- Shoulder Dislocation
- Being tested
- Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability, Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability
- Keywords
- Blood flow restriction, Latarjet surgery, Rehabilitation
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instabilityDevice
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 instabilityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patient will not use BFR |
| Placebo 10% of pressure for arterial occlusion | Placebo comparator | Patient will use BFR sub optimally as described in the literature Receives: Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability |
| Interventional 50% of pressure for arterial occlusion | Experimental | Patient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature Receives: Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic strength
Concentric peak torque (Nm) IR-ER at 60°/sec
Measured: Preoperative and at 14 weeks postoperative
Isokinetic strength
Concentric peak torque (Nm) IR-ER at 240°/sec
Measured: Preoperative and at 14 weeks postoperative
Isokinetic strength
Eccentric peak torque (Nm) IR-ER at 60°/sec
Measured: Preoperative and at 14 weeks postoperative
Isokinetic strength
Concentric ratio (ER conc 60°/ IR conc 60°)
Measured: Preoperative and at 14 weeks postoperative
Isokinetic strength
Cocking gesture ratio (IR exc 60° /ER conc 240°)
Measured: Preoperative and at 14 weeks postoperative
Isometric strength
Flexion in the scapular plane (Nm)
Measured: Preoperative and at 14 weeks postoperative
Isometric strength
Athletic shoulder test (positions I, Y, T) (Nm)
Measured: Preoperative and at 14 weeks postoperative
Isometric strength
Grip test (Nm)
Measured: Preoperative and at 14 weeks postoperative
Secondary outcomes (8)
Shoulder mobility
Flexion
Measured: Preoperative and at 14 weeks postoperative
Shoulder mobility
Abduction
Measured: Preoperative and at 14 weeks postoperative
Shoulder mobility
Internal rotation at 90° abduction
Measured: Preoperative and at 14 weeks postoperative
Shoulder mobility
External rotation at 90° abduction
Measured: Preoperative and at 14 weeks postoperative
Shoulder mobility
Scapular dyskinesis test (SDT)
Measured: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Modified closed kinetic upper extremity stability test
Measured: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Shoulder Instability Return to Sport Index (SIRSI)
Measured: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Western Ontario Shoulder Instability Index (WOSI)
Measured: Preoperative and at 14 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start10 Jun 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ensemble Hospitalier de la Côte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaud Meylan, Ensemble Hospitalier de la Côte
- Investigators
- Bauer Stefan, MD, Study director, EHC Morges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430567
- Sponsor's protocol ID
- EHC Morges BFR
- Acronym
- BFR
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Blood Flow Restriction Training and Traditional Resistance Training in Post-surgery Rehabilitation of Latarjet Procedure
- ClinicalTrials.gov ID
- NCT06430567
- Acronym / sponsor ID
- BFR / EHC Morges BFR
- Conditions
- Shoulder Dislocation
- Keywords
- Blood flow restriction, Latarjet surgery, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ensemble Hospitalier de la CôteUniversity, hospital or other
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patient will not use BFR |
| Placebo 10% of pressure for arterial occlusion | Placebo comparator | Device: Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instabilityPatient will use BFR sub optimally as described in the literature |
| Interventional 50% of pressure for arterial occlusion | Experimental | Device: Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instabilityPatient will use the minimal pressure of 50% of arterial occlusion known to be effective in the literature |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction (50% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instabilityParticipants 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. | Device | Interventional 50% of pressure for arterial occlusion |
| Blood flow restriction (10% AOP compression) in the rehabilitation phase after Latarjet surgery for chronic shoulder instabilityParticipants 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. | Device | Placebo 10% of pressure for arterial occlusion |
Primary outcome
Isokinetic strength
Time frame: Preoperative and at 14 weeks postoperative
Concentric peak torque (Nm) IR-ER at 60°/sec
Isokinetic strength
Time frame: Preoperative and at 14 weeks postoperative
Concentric peak torque (Nm) IR-ER at 240°/sec
Isokinetic strength
Time frame: Preoperative and at 14 weeks postoperative
Eccentric peak torque (Nm) IR-ER at 60°/sec
Isokinetic strength
Time frame: Preoperative and at 14 weeks postoperative
Concentric ratio (ER conc 60°/ IR conc 60°)
Isokinetic strength
Time frame: Preoperative and at 14 weeks postoperative
Cocking gesture ratio (IR exc 60° /ER conc 240°)
Isometric strength
Time frame: Preoperative and at 14 weeks postoperative
Flexion in the scapular plane (Nm)
Isometric strength
Time frame: Preoperative and at 14 weeks postoperative
Athletic shoulder test (positions I, Y, T) (Nm)
Isometric strength
Time frame: Preoperative and at 14 weeks postoperative
Grip test (Nm)
8 secondary outcomes
Shoulder mobility
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Time frame: Preoperative and at 14 weeks postoperative
Shoulder mobility
Time frame: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Time frame: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Time frame: Preoperative and at 14 weeks postoperative
Scapular girdle stability
Time frame: Preoperative and at 14 weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bauer Stefan, MD study director
EHC Morges
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Shoulder Dislocation, run by Ensemble Hospitalier de la Côte.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bauer Stefan, MD (0787105993 ext. +41, stefan.bauer@ehc.vd.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic strength (time frame: Preoperative and at 14 weeks postoperative). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.