Blood Flow Restriction Training (BFR) in an Adolescent Population
Condition: Blood Flow Restriction; ACL Tear; ACL Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      While there are a number studies that have reported on the use of BFR in the adult
      population, there is limited information about the use of BFR in the adolescent population.
      This study aims to evaluate the use of BFR training in conjunction with traditional ACL
      (anterior cruciate ligament) reconstruction rehabilitation in adolescents.

      The purpose of this study is to evaluate the addition of BFR-based exercise to traditional
      methods of physical therapy. Does the use of BFR-based exercise improve strength,
      hypertrophy, functional and patient reported outcomes after ACL Reconstruction in the
      adolescent population?
    

Detailed description: 
      The planned pilot study is a prospective case control study utilizing retrospective controls.
      The investigators will compare the use of exercises augmented with BFR with quantitative
      measurements of strength and patient reported outcomes. A total of 20 youth and adolescent
      patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's
      Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports
      Physical Therapy will be recruited for this study. A review of data from 20 previous
      patients, matched for age, sex, BMI and surgical procedure that completed physical therapy at
      Connecticut Children's Sports Physical Therapy will be used as a comparison.

      As part of this pilot study, the investigators will additionally collect prospective
      controls. This population will be patients not participating in physical therapy at
      Connecticut Children's, but underwent ACL reconstruction by Elite Sports Medicine. The
      investigators are unsure of the ability for us to collect prospective controls in a timely
      manner, hence the investigators will use the above described retrospective cohort as controls
      if the prospective controls prove difficult to recruit.

      Identification and Recruitment:

      All potential patients undergoing ACL reconstruction at Elite Sports Medicine will be
      approached for participation for this study. Eligible patients will be identified at their
      initial pre-operative appointment with the Sports Medicine Physician, Athletic Trainer, and
      Sports Physical Therapy Physical Therapist. Subject selection will be completed by those
      patients meeting the above outlined inclusion and exclusion criteria. At this time, the study
      purpose and protocol will be explained and a brief summary of the study will be provided.

      Consent: Consent will take place at the pre-operative visit. The patient/parent will be given
      a detailed description of the purpose and methodology for this study. The participants will
      have the opportunity to read the consent forms and ask any questions they may have about the
      research. If the patients agree to participate, they will be asked to sign the consent form
      and a copy will be provided.

      Retention: Eligible patients will be required to be seen for a minimum of 90% of patient
      visits to be included in this study.

      In addition to the standard ACL protocol, patients in this study will utilize the Owen
      Recovery Science exercise protocol for BFR [18]. The following guidelines will be followed
      concerning exercise progression, occlusion pressure and difficulties with volume achievement.
      To determine the appropriate resistance for each exercise, the patient's 1 repetition maximum
      (1RM) will be attained using a repetition test [19]. This test will use a previously
      validated algorithm to determine the 1RM based on the weight used to perform a 7-10
      repetition test [20]. Patient will perform the exercise with a weight they can comfortably
      lift for several repetitions. Based on the weight or resistance used, and the patient's
      perceived exertion a 1RM will be estimated using the modified OMNI-RES (OMNI perceived
      exertion scale for resistance). The starting load for each exercise will be 20-30% of their
      1RM , or bodyweight resistance will be used when loading is not feasible.

      Proposed Protocol Phase 1- Weeks 1 to 2

        -  Quad Set: 10 second on, 10 second rest at 100% occlusion x10'

           o progress to isometrics at the edge of the table 60 degrees as clinically appropriate

        -  Side Lying Hip Abduction, 30/15/15/15, at 80% occlusion

        -  Hip Extension from prone 30/15/15/15, at 80% occlusion

        -  Re-check load at the start of each Phase, to determine 1 RM (7-10 RM (repetition
           maximum) test on leg press)

        -  Total BFR time approximately 24 minutes per session, with 2 sessions per week

      Phase 2- Weeks 3 to 4

        -  Replace Quad Set with Long Arc Quad (90-30deg), 30/15/15/15 at 80% occlusion

        -  Replace Hip Extension with Leg Press (shuttle), 30/15/15/15 at 80% occlusion

        -  Hip Abduction, 30/15/15/15 at 80% occlusion

        -  Total BFR time approximately 24 minutes per session with 2 sessions per week

      Phase 3- Weeks 5 to 6

        -  Long Arc Quad (90-30deg), 30/15/15/15 at 80% occlusion

        -  Leg Press (shuttle), 30/15/15/15 at 80% occlusion

        -  Replace Hip Abduction with Bilateral Hip Bridge, 30/15/15/15 at 80% occlusion

        -  Total BFR time approximately 24 minutes per session, with 2 sessions per week

      Phase 4- Weeks 7 to 8

        -  Leg Press (shuttle), 30/15/15/15 at 80% occlusion

        -  Replace Long Arc Quad with Step Up 30/15/15/15 at 80% occlusion

        -  Bilateral Hip Bridge, 30/15/15/15 at 80% occlusion

        -  Total BFR time approximately 24 minutes per session, with 2 sessions per week

      Phase 5- Weeks 9 to 12

        -  Replace Bilateral Hip Bridge with Medial Step Down, 30/15/15/15 at 80% occlusion

        -  Replace Step up with Split Squat, 30/15/15/15 at 80% occlusion

        -  Leg Press (shuttle), 30/15/15/15 at 80% occlusion

        -  Total BFR time approximately 24 minutes per session, with 2 sessions per week

      Phase 6- Weeks 11 to 12

        -  Progressively load exercises from phase 5

        -  Total BFR time approximately 24 minutes per session, with 2 sessions per week
    

Intervention name(s): Blood Flow Restriction using Delfi Personalized Tourniquet System
Intervention type(s): Device
Intervention description(s): The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
Other intervention name(s): FDA Establishment Registration Number 9681444. Device Listing Number E127474. Classification Number 878.5910. Product Code KCY. 510(k) Exempt. MID: XCDELMED1099VAN
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will compare the use of exercises augmented with BFR with quantitative measurements of strength and patient reported outcomes. A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study. A review of data from 20 previous patients, matched for age, sex, BMI and surgical procedure that completed physical therapy at Connecticut Children's Sports Physical Therapy will be used as a comparison.
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical therapy; rehabilitation