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

Last updated: July 15, 2024
Sponsor: Connecticut Children's Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Muscular Dystrophy

Knee Injuries

Myasthenia Gravis (Chronic Weakness)

Treatment

Blood Flow Restriction using Delfi Personalized Tourniquet System

Clinical Study ID

NCT05754632
22-139
  • Ages 12-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Prior to surgery participated in >50 hours/year of level I or II sports as definedby 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 ConnecticutChildren's.

Exclusion

Exclusion Criteria:

  • An additional lower extremity injury at time of knee injury or previous surgicalintervention on the knee (ipsilateral and contralateral)

  • Multiple ligament ruptures or trauma

  • Weight bearing restrictions for greater than 4 weeks after surgery due toconcomitant pathology such as meniscal root/radial repair, chondral pathology, ormulti-ligament pathology

  • Follow-up surgical procedures including, but not limited to, post-operativearthrofibrosis Inability to attend regular physical therapy sessions (≥80% ofpatient treatment sessions and all assessment visits

  • Contraindications to performing BFRT including known history of central orperipheral neurologic impairments, cardiac or metabolic condition or history of deepvein thrombosis (DVT).

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Blood Flow Restriction using Delfi Personalized Tourniquet System
Phase:
Study Start date:
June 08, 2023
Estimated Completion Date:
May 01, 2027

Study Description

A single randomized control trial will compare the use of exercises augmented with BFRT with quantitative measurements of strength and patient-reported outcomes. A total of 40 youth and adolescent patients undergoing a surgical procedure for ACLR and subsequent physical therapy at our institution will be recruited for this study. Patients will be randomized into one of two groups using computer randomization for allocation: the intervention group receiving BFRT as part of physical therapy, and the control group will follow the institution's standard ACLR rehabilitation protocol. Both groups will follow a time- and criterion-based standardized rehabilitation protocol. The primary outcomes will be isometric and isokinetic knee peak torque and limb symmetry indices. Secondary outcomes will be quadriceps hypertrophy via mid-thigh circumference and patient-reported outcomes.

Target Population Adolescent patients between the ages of 12 and 18 will be recruited at the time of surgery, specifically, those that participate in sports who are undergoing primary ACLR reconstruction at Connecticut Children's

Study Group and Control Group Inclusion Criteria

· 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) Running, twisting, turning (racquet sports, baseball, hockey) Level II sports (1-3 days/week) Jumping, hard pivoting, cutting (basketball, volleyball, football, soccer, gymnastics, skiing. wrestling) Running, twisting, turning (racquet sports, baseball, hockey)

  • Completion of postoperative rehabilitation following standard protocols

  • Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.

Connect with a study center

  • Connecticut Children's Sports Physical Therapy

    Farmington, Connecticut 06032
    United States

    Active - Recruiting

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