RecruitingNot Applicable

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

United States40 participantsStarted 2023-06-08

Plain-language 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?

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Range of Motion

Timeframe: 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

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isometric Quadriceps Strength limb symmetry index

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isometric Hamstring Strength Peak Torque

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isometric Hamstring Strength Limb Symmetry Index

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isokinetic Quadriceps strength

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

Isokinetic Quadriceps Strength limb symmetry index

Trial details

NCT IDNCT05754632

SponsorConnecticut Children's Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Adam P Weaver, PT, DPT

8602840296 aweaver@connecticutchildrens.org

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injuries trials

Plain-language summary

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Range of Motion

Timeframe: 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

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isometric Quadriceps Strength limb symmetry index

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isometric Hamstring Strength Peak Torque

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isometric Hamstring Strength Limb Symmetry Index

Timeframe: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op

Isokinetic Quadriceps strength

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

Isokinetic Quadriceps Strength limb symmetry index