RecruitingNot ApplicableNCT05754632

The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial


Sponsor

Connecticut Children's Medical Center

Enrollment

40 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

While there are a number studies that have reported on the use of blood flow restriction training (BFRT) in the adult population, there is limited information about the use of BFRT in the adolescent population. This study aims to evaluate the use of BFRT in conjunction with traditional anterior ligament reconstruction (ACLR) rehabilitation in adolescents. The purpose of this study is to compare the addition of a BFRT based exercise protocol to a standard ACL rehabilitation protocol in adolescents. Does the addition of BFRT-based exercise improve strength, hypertrophy, and patient reported outcomes after ACLR in the adolescent population?


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria5

  • Prior to surgery participated in >50 hours/year of level I or II sports as defined by Noyes et al and planned to return to prior level.
  • Level I Sports (4-7 days/week) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)
  • Level II sports (1-3 days/week) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)
  • Completion of postoperative rehabilitation following standard protocols
  • Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.

Exclusion Criteria5

  • An additional lower extremity injury at time of knee injury or previous surgical intervention on the knee (ipsilateral and contralateral)
  • Multiple ligament ruptures or trauma
  • Weight bearing restrictions for greater than 4 weeks after surgery due to concomitant pathology such as meniscal root/radial repair, chondral pathology, or multi-ligament pathology
  • Follow-up surgical procedures including, but not limited to, post-operative arthrofibrosis Inability to attend regular physical therapy sessions (≥80% of patient treatment sessions and all assessment visits
  • Contraindications to performing BFRT including known history of central or peripheral neurologic impairments, cardiac or metabolic condition or history of deep vein thrombosis (DVT).

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Interventions

DEVICEBlood Flow Restriction using Delfi Personalized Tourniquet System

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.


Locations(1)

Connecticut Children's Sports Physical Therapy

Farmington, Connecticut, United States

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NCT05754632


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