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Blood Flow RestrictionNCT04285879

Blood Flow Restriction Training (BFR) in an Adolescent Population

A study testing Blood Flow Restriction using Delfi Personalized Tourniquet System in people with Blood Flow Restriction and ACL Tear, run by Connecticut Children's Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Blood Flow Restriction, ACL Tear, ACL Injury
What is being tested?
Blood Flow Restriction using Delfi Personalized Tourniquet System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
15 Dec 2020to 16 Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients between the age of 12 and 18 years at the time of surgery.
  • Post-primary ACL reconstruction
  • Orthopaedic surgical intervention (including all additional procedures at the knee) completed by one of the Elite Sports Medicine physicians.
  • Patient completed postoperative rehabilitation following standard protocols
  • No contraindications to performing BFR, as outlined in the Owens Recovery[18] Science 2018 Personal Blood Flow Restriction manual.

Who cannot join

  • Patients older than 18 and younger than 12 at the time of surgery
  • Any additional diagnoses or deformity not related to knee injury that could affect knee strength
  • Additional lower extremity injury at time of knee injury (e.g., ankle injury) requiring treatment
  • Previous surgical intervention on the knee (ipsilateral and contralateral)
  • Patients with weight bearing restrictions for greater than two weeks after surgery due to concomitant pathology such as meniscal root/radial repair, chondral pathology, or multi-ligament pathology. . Generic exclusion: "Subjects not meeting all inclusion criteria."

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Connecticut Children's Sports Physical Therapy

    Farmington, Connecticut, 06032

Other trials in United States

About this study

Official title: A Determination of Efficacy and Therapeutic Benefits of Blood Flow Restriction Training in an Adolescent Population

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?

Read the 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'
  • 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
Being tested
Blood Flow Restriction using Delfi Personalized Tourniquet System
Keywords
physical therapy, rehabilitation
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Flow Restriction using Delfi Personalized Tourniquet SystemDevice

    Also called FDA Establishment Registration Number 9681444. Device Listing Number E127474. Classification Number 878.5910. Product Code KCY. 510(k) Exempt. MID: XCDELMED1099VAN

    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

Study groups in NCT04285879
Study groupRoleWhat they receive
BFR Exercise GroupExperimentalIn 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. 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.
Receives: Device: Blood Flow Restriction using Delfi Personalized Tourniquet System
Non-BFR exercise groupNo interventionAs 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Isometric Quad Strength Peak Torque

    Isometric strength testing to measure peak torque quadriceps strength (unit: nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.

    Measured: 3 month and return to sport post-operative strength (6-8 months post-op)

  2. Isometric Quad Strength Limb Symmetry Index

    Quadriceps limb symmetry index is calculated by taking the values from outcome 1. [ ( peak torque quadriceps involved limb (nm-kg)/ peak torque quadriceps uninvolved limb (nm-kg))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry. Should involve limb demonstrate greater strength then uninvolved limb symmetry scores would be greater then 100%

    Measured: 3 month and return to sport isometric quad strength limb symmetry

  3. Isometric Hamstring Strength Peak Torque

    Isometric strength testing to measure peak torque hamstring strength (unit:nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.

    Measured: at 3 months post-op and return to sport (between approximately 6-8 months post-op)

  4. Isometric Hamstring Strength Limb Symmetry Index

    Hamstring limb symmetry index is calculated by taking the values from outcome 3 [ ( peak torque hamstring involved limb (nm-kg) / peak torque hamstring uninvolved limb (nm-kg))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal symmetry. For patients that demonstrate a stronger involved limb then uninvolved limb symmetry will be reported as greater then 100%

    Measured: 3 months post op and return to sport (between approximately 6-8 months post-op)

Secondary outcomes (1)
  1. Pedi-IKDC (International Knee Documentation Committee)

    Patient Reported Outcome Measure- Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

    Measured: at 3 months post-op and return to sport (between approximately 6-8 months post-op)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2020
  2. Study start15 Dec 2020
  3. Primary completion15 Jan 2023
  4. Study completion16 Oct 2023

Resources

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
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04285879
Sponsor's protocol ID
19-168
Status last verified
Jul 2024
First submitted
20 Feb 2020
Last updated
17 Jul 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood Flow Restriction using Delfi Personalized Tourniquet System in people with Blood Flow Restriction and ACL Tear, run by Connecticut Children's Medical Center 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 5 inclusion and 5 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 17 Jul 2024. 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?

Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Isometric Quad Strength Peak Torque (time frame: 3 month and return to sport post-operative strength (6-8 months post-op)). The study lists 4 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 17 Jul 2024.

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