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NCT Number: NCT05754632

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

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?

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Quadriceps Muscle Atrophy Wounds and Injuries

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Sports Physical Therapy

Farmington, Connecticut, 06032, United States

Location status: Recruiting

Location contact

Adam P Weaver, PT, DPT

CONTACT

[email protected]

860-284-0246 ext. 79296

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood Flow Restriction using Delfi Personalized Tourniquet System

Device

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.

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

Primary outcomes

  1. 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

    Active knee range of motion: Knee AROM will be measured in supine position using a goniometer and standardized procedures reported by Norkin and White

  2. 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 strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.

  3. 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

    Quadriceps limb symmetry index is calculated by taking the values from outcome 1. [ ( peak torque quadriceps involved limb (ft/lbs)/ peak torque quadriceps uninvolved limb (ft-lbs))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry.

  4. 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 strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.

  5. 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

    Hamstring limb symmetry index is calculated by taking the values from outcome 3 [ ( peak torque hamstring involved limb (ft/lbs) / peak torque hamstring uninvolved limb (ft-lbs))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal perfect symmetry.

  6. Isokinetic Quadriceps strength

    Time frame: Change in strength at 6 months and 9 months post-op

    Isokinetic strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.

  7. Isokinetic Quadriceps Strength limb symmetry index

    Time frame: Change in strength at 6 months and 9 months post-op

    Quadriceps limb symmetry index is calculated by taking the values from outcome 1. [ ( peak torque quadriceps involved limb (ft/lbs)/ peak torque quadriceps uninvolved limb (ft-lbs))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry.

  8. Isokinetic Hamstrings Strength

    Time frame: Change in strength at 6 months and 9 months post-op

    Isokinetic strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.

  9. Isokinetic Hamstring Strength limb symmetry index

    Time frame: Change in strength at 6 months and 9 months post-op

    Hamstring limb symmetry index is calculated by taking the values from outcome 1. [ ( peak torque quadriceps involved limb (ft/lbs)/ peak torque quadriceps uninvolved limb (ft-lbs))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry.

Secondary outcomes

  1. Quadriceps Hypertrophy

    Time frame: Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op

    Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity

  2. 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

    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).

  3. 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

    Patient Reported Outcome Measure- The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems. This scoring direction, 100 indicating no problems

  4. 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

    Patient Reported Outcome Measure- The scores range from 0 to 100, with higher scores representing patients who are more ready to return to sport

  5. Tegner Activity Scale

    Time frame: changes from pre-operative, 9 months, and 2 years post-operative

    Tegner activity scale will measure sport level- higher level equals higher sport competitive level

Study contacts

Contact information is provided by the study sponsor or research team.

Adam P Weaver, PT, DPT

CONTACT

[email protected]

8602840296 ext. 79296

Arthur Fredericks, MSPT

CONTACT

[email protected]

8602840296 ext. 79296

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Collaborators

  • University of Connecticut

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Mar 6, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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