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Recruiting NCT05754632

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

No phase Interventional Anterior Cruciate Ligament Injuries Knee Injuries Quadriceps Muscle Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Flow Restriction using Delfi Personalized Tourniquet System.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injuries, Knee Injuries, Quadriceps Muscle Atrophy. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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?

Detailed 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.

Interventions

  • Device Blood 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.

Primary outcome measures

  • Range of Motion [Time frame: Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op]
  • Isometric Quad strength Peak Torque [Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op]
  • Isometric Quadriceps Strength limb symmetry index [Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op]
  • Isometric Hamstring Strength Peak Torque [Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op]
  • Isometric Hamstring Strength Limb Symmetry Index [Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op]
  • Isokinetic Quadriceps strength [Time frame: Change in strength at 6 months and 9 months post-op]
  • Isokinetic Quadriceps Strength limb symmetry index [Time frame: Change in strength at 6 months and 9 months post-op]
  • Isokinetic Hamstrings Strength [Time frame: Change in strength at 6 months and 9 months post-op]
  • Isokinetic Hamstring Strength limb symmetry index [Time frame: Change in strength at 6 months and 9 months post-op]
Secondary outcome measures (5)
  • Quadriceps Hypertrophy [Time frame: Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op]
  • Pediatric International Knee Documentation Committee [Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op]
  • Knee Outcomes and Osteoarthritis Scale [Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op]
  • Anterior Cruciate Ligament- Return to Sport after Injury [Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op]
  • Tegner Activity Scale [Time frame: changes from pre-operative, 9 months, and 2 years post-operative]

Eligibility criteria

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)

  • 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 criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Connecticut Children's Sports Physical Therapy — Farmington

Identifiers

NCT: NCT05754632 · 22-139

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗