N/A
N=47
Blood Flow Restriction Training (BFR) in an Adolescent Population
Blood Flow Restriction · ACL Tear · ACL Injury
Bottom Line
View on ClinicalTrials.gov: NCT04285879 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Isometric Quad Strength Peak Torque — 1.83; 1.31; 2.45; 2.1 Nm/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Flow Restriction using Delfi Personalized Tourniquet System (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Connecticut Children's Medical Center
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Isometric Quad Strength Peak Torque |
1.83; 1.31; 2.45; 2.1 | — |
| PRIMARY Isometric Quad Strength Limb Symmetry Index |
68.02; 60.72; 89.53; 80.97 | — |
| PRIMARY Isometric Hamstring Strength Peak Torque |
1.20; 1.61; 1.53; 1.3 | — |
| PRIMARY Isometric Hamstring Strength Limb Symmetry Index |
108.32; 80.3; 96.74; 85.61 | — |
| SECONDARY Pedi-IKDC (International Knee Documentation Committee) |
68.91; 71.82; 89.42; 80.90 | — |
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?
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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."
Data sourced from ClinicalTrials.gov (NCT04285879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.