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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorConnecticut Children's Medical Center

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: BFR Intervention GroupExperimental treatment 1 intervention
Group B: No Intervention/Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Range of Motion

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

Time frame
Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
2

Isometric Quad strength Peak Torque

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

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

Isometric Quadriceps Strength limb symmetry index

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.

Time frame
Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
4

Isometric Hamstring Strength Peak Torque

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

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

Secondary outcomes

1

Quadriceps Hypertrophy

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

Time frame
Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op
2

Pediatric International Knee Documentation Committee

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).

Time frame
Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
3

Knee Outcomes and Osteoarthritis Scale

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

Time frame
Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
4

Anterior Cruciate Ligament- Return to Sport after Injury

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

Time frame
Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op

Other outcomes

Sponsors and contacts

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Connecticut Children's Medical Center

Lead sponsor

University of Connecticut

Collaborator