Anterior Shoulder DislocationNCT05506072
Blood Flow Restriction Training Versus Standard Physical Therapy After Shoulder Stabilization Surgery
A study testing Blood flow restriction therapy and Standard Physical Thearapy in people with Anterior Shoulder Dislocation and Recurrent Shoulder Dislocation, run by Keller Army Community Hospital at 1 site in United States.
Trial summary
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses: The purpose of this Randomized Controlled Trial is to evaluate the effectiveness of Blood Flow Restriction (BFR) training with standard care of physical therapy versus the standard care of Physical Therapy alone… Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Shoulder Dislocation, Recurrent Shoulder Dislocation, Shoulder Subluxation
- What is being tested?
- Blood flow restriction therapy and Standard Physical Thearapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- enrolled in the US Military Academy as a Cadet?
- between the age of 17 to 30 years?
- USMA cadet who was diagnosed with unilateral or multi-directional instability who underwent primary or revised surgery as well as open and arthroscopic shoulder stabilization surgery procedures at KACH.
- near 6 weeks post-operative at start and will be cleared to begin strengthening exercises at that time
Who cannot join
- Have not had a rotator cuff surgery with the current surgical repair?
- Have not had a humeral neck or shaft fracture?
- Had not had a history of head, neck, or shoulder procedures requiring general anesthesia within 6 weeks from surgery
- Have not had a history of deep vein thrombosis (DVT) within the 12 months from your surgical date
- Not currently pregnant
- Don't have a history of upper quadrant lymph node dissection, endothelial dysfunction
- Don't have an active infection or are you currently diagnosed and fighting cancer
- Don't bruise easily and/or have a bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Keller Army Community Hospital - ARVIN
West Point, New York, 10996
About this study
Official title: Blood Flow Restriction Training Versus Standard Physical Therapy After Shoulder Stabilization Surgery: A Randomized Controlled Trial.
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses:
The purpose of this Randomized Controlled Trial is to evaluate the effectiveness of Blood Flow Restriction (BFR) training with standard care of physical therapy versus the standard care of Physical Therapy alone and its effect on shoulder function and patient outcomes in military cadets recovering from shoulder stabilization surgery. We hypothesize after 6 weeks of BFR training will contribute to 13 (76%) or more participants will achieve scores within one standard deviation of normative values for isometric strength and functional tests at six months following shoulder stabilization surgery.
Read more
Furthermore, we hypothesize that 14 (82%) or more participants will report improved patientreported outcomes as determined by the minimal clinical difference (MCD) at 12 weeks and six months post-operatively. Objective 1: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder isometric strength, as measured by a digital handheld dynamotor following shoulder stabilization surgery in military cadets. Objective 2: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder range of motion, as measured by a digital inclinometer, following shoulder stabilization surgery in military cadets. Objective 3: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder function as measured by the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), Seated Shot-Put Test (SSPT), and Upper Quarter Y-Balance Test (UQYBT), following shoulder stabilization surgery in military cadets. Objective 4: To evaluate the effectiveness of BFR training on shoulder pain, measured by a numerical pain rating scale, following shoulder stabilization surgery in military cadets.
Objective 5: To evaluate the effectiveness of a BFR training on patient-reported outcomes, measured by Single Assessment Numeric Evaluation (SANE), Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder and Hand (DASH) following shoulder stabilization surgery in military cadets. Aim 1:To identify whether BFR with Physical Therapy is more effective at increasing shoulder strength than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder strength than the Physical Therapy group without BFR following shoulder stabilization surgery. Aim 2:To identify whether BFR with Physical Therapy is more effective at increasing shoulder function than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder function than the Physical Therapy group without BFR following shoulder stabilization surgery.
Read the detailed description
During study:
Participants will be recruited from the Keller Army Community Hospital (KACH) the KACH Orthopedic Clinic and the Arvin Cadet Physical Therapy Clinic. Participants will be screened for possible benefits of participation and related inclusion
/exclusion criteria as is done within traditional means by the referring provider.
Participant recruitment and briefing by the lead primary investigator (PI) or associate investigator (AI) will be conducted.
Participants wishing to participate in the study will undergo informed consent process with PI or AI. Participants agreeing to participate will complete consent by signing an informed consent form and HIPAA authorization form. All data will be recorded and stored by the subject identification number. Participants will be randomized into their assigned group of either receiving standard therapy with Blood Flow Restriction (BFR) or standard therapy alone by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of Blood Flow Restriction Training and/or standard rehabilitation exercises. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training. Baseline Testing All participants will undergo baseline testing at 6 weeks in the following order: 1.
Demographic data 2. self-report outcome measures; 3. Range of motion (ROM) testing; 4.
isometric strength testing. Initial patient reported outcome measures will be recorded on the Numerical Pain Rating Scale (NPRS), the Single Assessment Numeric Evaluation (SANE), the Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder, Hand (DASH).
Initial shoulder flexion, external rotation (ER), and internal rotation (IR) Range of Motion (ROM) measurements will be conducted using the digital inclinometer Initial shoulder isometric abduction, ER, and IR strength will be assessed using a handheld dynamometer. Intervention Participants will either receive the current standard of care in post-operative shoulder stabilization rehabilitation without BFR training during each treatment session or current standard of care in post-operative shoulder stabilization rehabilitation plus BFR training.
BFR will be done via Delfi Portable Tourniquet System (BFR (Delfi Medical Innovations Inc., Vancouver, Canada) All participants will perform their rehabilitation a minimum of two times per week in the rehabilitation clinic. Patient contact time with their medical providers will be the same in both groups. The BFR treatment with the BFR group will be applied during each treatment session for 6 weeks (weeks 6-12). Pain will be assessed at the beginning and end of each treatment session using the Numerical Pain Rating Scale, in accordance with standard clinical practice. Exercise intensity will be determined each session using the OMNI res scale and participants will use that load for their daily exercises. The BFR group will exercise at an intensity of 2-3 on the OMNI res scale on the involved side and then exercise at a 6-8 on the uninvolved side. The non-BFR group will exercise at a 6-8 on the involved and uninvolved side. These loads will be annotated and used be referred to when completing strengthening exercises. Participants will then perform a 30-minute session of rehabilitation. The BFR group will apply the BFR tourniquet and it will be inflated to 50% Limb Occlusion Pressure (LOP) throughout the duration of the treatment. The upper body aerobic exercise will be performed on an upper body cycle (UBC). Intensity will be determined by the perceived exertion of OMNI Res at a resistance the participant considers easy(2-3). The strengthening exercises will consist of three unilateral standing exercises to be performed on both upper extremities. The exercises to be performed are ER with the shoulder adducted to the thorax, scapular retraction with a combined low row, and flexion in scapular plane. Each exercise will be performed while standing using Keiser Functional Trainer (Keiser Corp model 003025.15, Fresno, CA). The resistance for the strengthening exercises will be selected as described above using the Omni res scale. All participants will perform 75 repetitions in total per exercise broken in to 4 sets (30,15,15,15). A 30 second rest period will be issued between exercises. Participants will be permitted to increase or decrease the resistance as needed to stay within the specified perceived exertion range but will be annotated for any deviation from pre-load assessment. The treatment session will end when a participant completes all sets and repetitions for each exercise. However, if a participant is unable to complete all exercises in 30 minutes, the BFR cuff will be deflated and removed. Then, the participant will finish the exercises without BFR. Patients will also perform a home exercise program(HEP) that reinforces the in-clinic treatment. Compliance with the home exercise program will be documented by a patient log to be completed daily and turned into the project manager weekly. All groups will perform their HEP strength exercises at same perceived load intensity of a 6-8 on the OMNI res scale. Assessments (6 weeks); Follow up (12-week, and 6 months post-surgery)
All participants will undergo baseline and follow-up testing in the following order: 1. self report outcome measures; 2. Range of motion testing; 3. isometric strength testing; 4. Functional testing at 6-month follow-up only Follow-up patient reported outcome measures will be recorded on the Numerical Pain Rating Scale (NPRS), the Single Assessment Numeric Evaluation (SANE), the Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder, Hand (DASH). Shoulder flexion, external rotation (ER), and internal rotation (IR) Range of Motion (ROM) measurements will be conducted using the digital inclinometer Shoulder isometric abduction, ER, and IR strength will be assessed using a hand-held dynamometer. Functional tests will be conducted in the same order: Closed Kinetic Chain Upper Extremity Stability Test (CKQUEST), Upper Quarter Y Balance Test (UQYBT), Seated Shotput Test (SSPT) Study participation completed after the 6-month follow-up
- Conditions
- Anterior Shoulder Dislocation, Recurrent Shoulder Dislocation, Shoulder Subluxation, Surgery
- Being tested
- Blood flow restriction therapy, Standard Physical Thearapy
- 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 therapyOther
Blood Flow Restriction involves the application of a tourniquet to an extremity to partially restrict the arterial and venous blood flow to stimulate localized cellular and systemic hormonal changes that occur in high intensity exercise. BFR Training may produce similar cellular and muscular responses to cause hypertrophy when exercise is performed at low intensity. Studies have compared BFR therapy in the lower extremities with light load resistance exercise to light load resistance alone and observed greater improvements in the BFR group. A recent systematic review further identified that adding BFR to exercise effectively augments muscle strength and size. Additionally, BFR has been shown to be applied in a safe manner with low risk for complications. With this growing body of evidence supporting BFR, it is becoming increasingly common in rehabilitation
Standard Physical ThearapyOther
Participants will be randomized into their assigned group of receiving standard therapy without BFR by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of standard rehabilitation exercises without BFR.
Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training.
| Study group | Role | What they receive |
|---|---|---|
| BFR group with standard therapy | Experimental | Participants will be randomized into their assigned group of receiving standard therapy with BFR by a blinded therapist within the study. Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of Blood Flow Restriction Training with the standard rehabilitation exercises. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training. Receives: Other: Blood flow restriction therapy; Other: Standard Physical Thearapy |
| standard therapy group | Active comparator | Participants will be randomized into their assigned group of receiving standard therapy without BFR by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of standard rehabilitation exercises without BFR.
Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training. Receives: Other: Blood flow restriction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder Isometric strength
resisted isometric strength using dynamotor
Measured: 6 weeks
shoulder Isometric strength
resisted isometric strength using dynamotor
Measured: 12 weeks
shoulder Isometric strength
resisted isometric strength using dynamotor
Measured: 6 months
shoulder function- (CKCUEST)
Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST)
Measured: 6 months
shoulder function- (UQYBT)
Upper Quarter Y Balance Test (UQYBT)
Measured: 6 months
shoulder function-(SSPT)
Seated Shotput Test (SSPT)
Measured: 6 months
Secondary outcomes (15)
Numerical Pain Rating Scale (NPRS)
report self pain rating
Measured: 6 weeks
Numerical Pain Rating Scale (NPRS)
report self pain rating
Measured: 12 weeks
Numerical Pain Rating Scale (NPRS)
report self pain rating
Measured: 6 months
Shoulder Pain and Disability Index (SPADI)
self reported patient outcomes
Measured: 6 weeks
Shoulder Pain and Disability Index (SPADI)
self reported patient outcomes
Measured: 12 weeks
Shoulder Pain and Disability Index (SPADI)
self reported patient outcomes
Measured: 6 months
Single Assessment Numeric Evaluation (SANE)
self reported patient outcomes
Measured: 6 weeks,
Single Assessment Numeric Evaluation (SANE)
self reported patient outcomes
Measured: 12 weeks
Single Assessment Numeric Evaluation (SANE)
self reported patient outcomes
Measured: 6 months
Quick Disabilities of Arm, Shoulder, Hand (QDASH)
self reported patient outcomes
Measured: 6 weeks
Quick Disabilities of Arm, Shoulder, Hand (QDASH)
self reported patient outcomes
Measured: 12 weeks
Quick Disabilities of Arm, Shoulder, Hand (QDASH)
self reported patient outcomes
Measured: 6 months
ROM
shoulder Range of motion using the digital inclinometer
Measured: 6 weeks
ROM
shoulder Range of motion using the digital inclinometer
Measured: 12 weeks
ROM
shoulder Range of motion using the digital inclinometer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start23 Jun 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jamie Morris, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506072
- Sponsor's protocol ID
- KACH.2022.0058
- Other IDs
- 22KACH005
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2022
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Following the completion of this study, subject will have the option to allow, or not allow the researchers to keep your data and use it in the future. At the end of the consent form subject will choose to give permission, or not, to use protected health information and study data (non-protected health information) for future research studies. Following study completion, we will remove anything that might identify subject from the information. If subject chooses so, the remaining de-identified information may then be used for future research studies or given to another investigator without getting additional permission from the subject. If we do want to use the information or give the information to another investigator for future research, a review board will decide whether this is allowed.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training Versus Standard Physical Therapy After Shoulder Stabilization Surgery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05506072
- Acronym / sponsor ID
- KACH.2022.0058
- Conditions
- Anterior Shoulder Dislocation, Recurrent Shoulder Dislocation, Shoulder Subluxation, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 18 Aug 2022 (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.
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses:
The purpose of this Randomized Controlled Trial is to evaluate the effectiveness of Blood Flow Restriction (BFR) training with standard care of physical therapy versus the standard care of Physical Therapy alone and its effect on shoulder function and patient outcomes in military cadets recovering from shoulder stabilization surgery. We hypothesize after 6 weeks of BFR training will contribute to 13 (76%) or more participants will achieve scores within one standard deviation of normative values for isometric strength and functional tests at six months following shoulder stabilization surgery.
Furthermore, we hypothesize that 14 (82%) or more participants will report improved patientreported outcomes as determined by the minimal clinical difference (MCD) at 12 weeks and six months post-operatively. Objective 1: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder isometric strength, as measured by a digital handheld dynamotor following shoulder stabilization surgery in military cadets. Objective 2: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder range of motion, as measured by a digital inclinometer, following shoulder stabilization surgery in military cadets. Objective 3: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder function as measured by the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), Seated Shot-Put Test (SSPT), and Upper Quarter Y-Balance Test (UQYBT), following shoulder stabilization surgery in military cadets. Objective 4: To evaluate the effectiveness of BFR training on shoulder pain, measured by a numerical pain rating scale, following shoulder stabilization surgery in military cadets.
Objective 5: To evaluate the effectiveness of a BFR training on patient-reported outcomes, measured by Single Assessment Numeric Evaluation (SANE), Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder and Hand (DASH) following shoulder stabilization surgery in military cadets. Aim 1:To identify whether BFR with Physical Therapy is more effective at increasing shoulder strength than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder strength than the Physical Therapy group without BFR following shoulder stabilization surgery. Aim 2:To identify whether BFR with Physical Therapy is more effective at increasing shoulder function than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder function than the Physical Therapy group without BFR following shoulder stabilization surgery.
Detailed description
During study:
Participants will be recruited from the Keller Army Community Hospital (KACH) the KACH Orthopedic Clinic and the Arvin Cadet Physical Therapy Clinic. Participants will be screened for possible benefits of participation and related inclusion
/exclusion criteria as is done within traditional means by the referring provider.
Participant recruitment and briefing by the lead primary investigator (PI) or associate investigator (AI) will be conducted.
Participants wishing to participate in the study will undergo informed consent process with PI or AI. Participants agreeing to participate will complete consent by signing an informed consent form and HIPAA authorization form. All data will be recorded and stored by the subject identification number. Participants will be randomized into their assigned group of either receiving standard therapy with Blood Flow Restriction (BFR) or standard therapy alone by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of Blood Flow Restriction Training and/or standard rehabilitation exercises. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training. Baseline Testing All participants will undergo baseline testing at 6 weeks in the following order: 1.
Demographic data 2. self-report outcome measures; 3. Range of motion (ROM) testing; 4.
isometric strength testing. Initial patient reported outcome measures will be recorded on the Numerical Pain Rating Scale (NPRS), the Single Assessment Numeric Evaluation (SANE), the Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder, Hand (DASH).
Initial shoulder flexion, external rotation (ER), and internal rotation (IR) Range of Motion (ROM) measurements will be conducted using the digital inclinometer Initial shoulder isometric abduction, ER, and IR strength will be assessed using a handheld dynamometer. Intervention Participants will either receive the current standard of care in post-operative shoulder stabilization rehabilitation without BFR training during each treatment session or current standard of care in post-operative shoulder stabilization rehabilitation plus BFR training.
BFR will be done via Delfi Portable Tourniquet System (BFR (Delfi Medical Innovations Inc., Vancouver, Canada) All participants will perform their rehabilitation a minimum of two times per week in the rehabilitation clinic. Patient contact time with their medical providers will be the same in both groups. The BFR treatment with the BFR group will be applied during each treatment session for 6 weeks (weeks 6-12). Pain will be assessed at the beginning and end of each treatment session using the Numerical Pain Rating Scale, in accordance with standard clinical practice. Exercise intensity will be determined each session using the OMNI res scale and participants will use that load for their daily exercises. The BFR group will exercise at an intensity of 2-3 on the OMNI res scale on the involved side and then exercise at a 6-8 on the uninvolved side. The non-BFR group will exercise at a 6-8 on the involved and uninvolved side. These loads will be annotated and used be referred to when completing strengthening exercises. Participants will then perform a 30-minute session of rehabilitation. The BFR group will apply the BFR tourniquet and it will be inflated to 50% Limb Occlusion Pressure (LOP) throughout the duration of the treatment. The upper body aerobic exercise will be performed on an upper body cycle (UBC). Intensity will be determined by the perceived exertion of OMNI Res at a resistance the participant considers easy(2-3). The strengthening exercises will consist of three unilateral standing exercises to be performed on both upper extremities. The exercises to be performed are ER with the shoulder adducted to the thorax, scapular retraction with a combined low row, and flexion in scapular plane. Each exercise will be performed while standing using Keiser Functional Trainer (Keiser Corp model 003025.15, Fresno, CA). The resistance for the strengthening exercises will be selected as described above using the Omni res scale. All participants will perform 75 repetitions in total per exercise broken in to 4 sets (30,15,15,15). A 30 second rest period will be issued between exercises. Participants will be permitted to increase or decrease the resistance as needed to stay within the specified perceived exertion range but will be annotated for any deviation from pre-load assessment. The treatment session will end when a participant completes all sets and repetitions for each exercise. However, if a participant is unable to complete all exercises in 30 minutes, the BFR cuff will be deflated and removed. Then, the participant will finish the exercises without BFR. Patients will also perform a home exercise program(HEP) that reinforces the in-clinic treatment. Compliance with the home exercise program will be documented by a patient log to be completed daily and turned into the project manager weekly. All groups will perform their HEP strength exercises at same perceived load intensity of a 6-8 on the OMNI res scale. Assessments (6 weeks); Follow up (12-week, and 6 months post-surgery)
All participants will undergo baseline and follow-up testing in the following order: 1. self report outcome measures; 2. Range of motion testing; 3. isometric strength testing; 4. Functional testing at 6-month follow-up only Follow-up patient reported outcome measures will be recorded on the Numerical Pain Rating Scale (NPRS), the Single Assessment Numeric Evaluation (SANE), the Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder, Hand (DASH). Shoulder flexion, external rotation (ER), and internal rotation (IR) Range of Motion (ROM) measurements will be conducted using the digital inclinometer Shoulder isometric abduction, ER, and IR strength will be assessed using a hand-held dynamometer. Functional tests will be conducted in the same order: Closed Kinetic Chain Upper Extremity Stability Test (CKQUEST), Upper Quarter Y Balance Test (UQYBT), Seated Shotput Test (SSPT) Study participation completed after the 6-month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR group with standard therapy | Experimental | Other: Blood flow restriction therapy, Other: Standard Physical ThearapyParticipants will be randomized into their assigned group of receiving standard therapy with BFR by a blinded therapist within the study. Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of Blood Flow Restriction Training with the standard rehabilitation exercises. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training. |
| standard therapy group | Active comparator | Other: Blood flow restriction therapyParticipants will be randomized into their assigned group of receiving standard therapy without BFR by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of standard rehabilitation exercises without BFR. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- enrolled in the US Military Academy as a Cadet?
- between the age of 17 to 30 years?
- USMA cadet who was diagnosed with unilateral or multi-directional instability who underwent primary or revised surgery as well as open and arthroscopic shoulder stabilization surgery procedures at KACH.
- near 6 weeks post-operative at start and will be cleared to begin strengthening exercises at that time
Key exclusion criteria (8 listed)
- Have not had a rotator cuff surgery with the current surgical repair?
- Have not had a humeral neck or shaft fracture?
- Had not had a history of head, neck, or shoulder procedures requiring general anesthesia within 6 weeks from surgery
- Have not had a history of deep vein thrombosis (DVT) within the 12 months from your surgical date
- Not currently pregnant
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 therapyBlood Flow Restriction involves the application of a tourniquet to an extremity to partially restrict the arterial and venous blood flow to stimulate localized cellular and systemic hormonal changes that occur in high intensity exercise. BFR Training may produce similar cellular and muscular responses to cause hypertrophy when exercise is performed at low intensity. Studies have compared BFR therapy in the lower extremities with light load resistance exercise to light load resistance alone and observed greater improvements in the BFR group. A recent systematic review further identified that adding BFR to exercise effectively augments muscle strength and size. Additionally, BFR has been shown to be applied in a safe manner with low risk for complications. With this growing body of evidence supporting BFR, it is becoming increasingly common in rehabilitation | Other | BFR group with standard therapy, standard therapy group |
| Standard Physical ThearapyParticipants will be randomized into their assigned group of receiving standard therapy without BFR by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of standard rehabilitation exercises without BFR. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training. | Other | BFR group with standard therapy |
Primary outcome
shoulder Isometric strength
Time frame: 6 weeks
resisted isometric strength using dynamotor
shoulder Isometric strength
Time frame: 12 weeks
resisted isometric strength using dynamotor
shoulder Isometric strength
Time frame: 6 months
resisted isometric strength using dynamotor
shoulder function- (CKCUEST)
Time frame: 6 months
Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST)
shoulder function- (UQYBT)
Time frame: 6 months
Upper Quarter Y Balance Test (UQYBT)
shoulder function-(SSPT)
Time frame: 6 months
Seated Shotput Test (SSPT)
15 secondary outcomes
Numerical Pain Rating Scale (NPRS)
Time frame: 6 weeks
Numerical Pain Rating Scale (NPRS)
Time frame: 12 weeks
Numerical Pain Rating Scale (NPRS)
Time frame: 6 months
Shoulder Pain and Disability Index (SPADI)
Time frame: 6 weeks
Shoulder Pain and Disability Index (SPADI)
Time frame: 12 weeks
Shoulder Pain and Disability Index (SPADI)
Time frame: 6 months
Single Assessment Numeric Evaluation (SANE)
Time frame: 6 weeks,
Single Assessment Numeric Evaluation (SANE)
Time frame: 12 weeks
Single Assessment Numeric Evaluation (SANE)
Time frame: 6 months
Quick Disabilities of Arm, Shoulder, Hand (QDASH)
Time frame: 6 weeks
Quick Disabilities of Arm, Shoulder, Hand (QDASH)
Time frame: 12 weeks
Quick Disabilities of Arm, Shoulder, Hand (QDASH)
Time frame: 6 months
ROM
Time frame: 6 weeks
ROM
Time frame: 12 weeks
ROM
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided. Following the completion of this study, subject will have the option to allow, or not allow the researchers to keep your data and use it in the future. At the end of the consent form subject will choose to give permission, or not, to use protected health information and study data (non-protected health information) for future research studies. Following study completion, we will remove anything that might identify subject from the information. If subject chooses so, the remaining de-identified information may then be used for future research studies or given to another investigator without getting additional permission from the subject. If we do want to use the information or give the information to another investigator for future research, a review board will decide whether this is allowed.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction therapy and Standard Physical Thearapy in people with Anterior Shoulder Dislocation and Recurrent Shoulder Dislocation, run by Keller Army Community Hospital at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder Isometric strength (time frame: 6 weeks). The study lists 6 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 23 Sep 2025.