Recruiting

Blood Flow Restriction

Sponsor:

Connecticut Children's Medical Center

Code:

NCT05754632

Conditions

Anterior Cruciate Ligament Injuries

Knee Injuries

Quadriceps Muscle Atrophy

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Blood Flow Restriction using Delfi Personalized Tourniquet System

Study Details

Brief 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?

Conditions

Anterior Cruciate Ligament Injuries

Knee Injuries

Quadriceps Muscle Atrophy

Study ID

NCT05754632

Start date

Jun 8, 2023

Status verified date

Jan, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: 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

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Adam P Weaver, PT, DPT

8602840296aweaver@connecticutchildrens.org

Arthur Fredericks, MSPT

8602840296afredericks@connecticutchildrens.org

Locations

Connecticut Children's Sports Physical Therapy

Recruiting

Farmington, Connecticut, United States, 06032

Contacts

Adam P Weaver, PT, DPT

860-284-0246aweaver@connecticutchildrens.org

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • physical therapy
  • rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-01-07.