The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial
NCT ID: NCT05754632
Last Updated: 2026-01-07
Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-06-08
2029-05-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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BFR Intervention Group
In addition to the standard ACL rehabilitation protocol, the experimental group will complete 2 exercises using the Delfi BFR cuff 2x/week for 8 weeks during their treatment session at Connecticut Children's Sports Physical Therapy on the second post-operative visit. Cuff size will be determined by patient thigh circumference Limb occlusion pressure will be determined in supine position and all exercises will be completed at 80% occlusion.
Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press
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.
No Intervention/Control Group
In addition to the standard ACL rehabilitation protocol, the control group will complete the same exercises as the experimental group starting on the second post-operative visit.
Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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).
12 Years
18 Years
ALL
No
Sponsors
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University of Connecticut
OTHER
Connecticut Children's Medical Center
OTHER
Responsible Party
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Principal Investigators
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Adam Weaver, PT, DPT
Role: PRINCIPAL_INVESTIGATOR
Physical Therapist
Locations
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Connecticut Children's Sports Physical Therapy
Farmington, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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22-139
Identifier Type: -
Identifier Source: org_study_id
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