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

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT05754632
Status
Recruiting
Apply to this trial

Conditions

  • Anterior Cruciate Ligament Injuries
  • Knee Injuries
  • Quadriceps Muscle Atrophy

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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?

Key Dates

Start date
Jun 8, 2023
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
May 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Children's Sports Physical TherapyFarmingtonConnecticut06032
Adam P Weaver, PT, DPT
[email protected]
860-284-0246

Find similar trials in Farmington, CT

By research site
Connecticut Children's Sports Physical Therapy· Farmington, CT

Related Studies