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BFR Training for ACL Injury

N/A
Waitlist Available
Led By Adam Weaver, PT, DPT
Research Sponsored by Connecticut Children's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-primary ACL reconstruction
No contraindications to performing BFR, as outlined in the Owens Recovery Science 2018 Personal Blood Flow Restriction manual
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in strength from 3months post-op, 6-9 months post-op
Awards & highlights

Study Summary

This trial will help to answer if BFR-based exercise is an effective addition to traditional rehabilitation methods for adolescents who have had ACL reconstruction surgery.

Who is the study for?
Adolescents aged 12-18 who've had ACL reconstruction and are following standard rehab protocols can join. They shouldn't have other knee injuries, surgeries, or conditions affecting strength, nor should they have contraindications to Blood Flow Restriction (BFR) as per the Owens Recovery Science manual.Check my eligibility
What is being tested?
The trial is testing if adding BFR exercises to regular physical therapy after ACL surgery helps improve muscle strength, growth, function, and patient-reported outcomes in adolescents.See study design
What are the potential side effects?
While not explicitly stated for this trial, potential side effects of BFR may include discomfort at the restriction site, numbness or tingling in the limb due to pressure from the tourniquet system used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have already had surgery to repair a torn ACL in your knee.
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You don't have any medical reasons that would make it unsafe for you to undergo Blood Flow Restriction (BFR) training, as explained in the Owens Recovery Science 2018 Personal Blood Flow Restriction manual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in strength from 3months post-op, 6-9 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in strength from 3months post-op, 6-9 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6 meter timed single leg hop
6meter timed hop symmetry
Anterior step down test
+14 more
Secondary outcome measures
ACL- RSI (Anterior Cruciate Ligament- Return to Sport after Injury)
KOOS (Knee Outcomes and Osteoarthritis Scale)
Marx Activity Rating Scale
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BFR Exercise GroupExperimental Treatment1 Intervention
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR [18]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement. A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Group II: Non-BFR exercise groupActive Control1 Intervention
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Flow Restriction using Delfi Personalized Tourniquet System
2020
N/A
~50

Find a Location

Who is running the clinical trial?

Connecticut Children's Medical CenterLead Sponsor
71 Previous Clinical Trials
31,465 Total Patients Enrolled
Adam Weaver, PT, DPTPrincipal Investigator - Physical Therapist
Connecticut Children's Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Blood Flow Restriction using Delfi Personalized Tourniquet System Clinical Trial Eligibility Overview. Trial Name: NCT04285879 — N/A
Anterior Cruciate Ligament Tear Research Study Groups: Non-BFR exercise group, BFR Exercise Group
Anterior Cruciate Ligament Tear Clinical Trial 2023: Blood Flow Restriction using Delfi Personalized Tourniquet System Highlights & Side Effects. Trial Name: NCT04285879 — N/A
Blood Flow Restriction using Delfi Personalized Tourniquet System 2023 Treatment Timeline for Medical Study. Trial Name: NCT04285879 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially partake in this medical research endeavor?

"This medical research seeks 49 participants with acl tears between tween and adolescent ages. The following stipulations must be met for eligibility: Orthopaedic surgical procedure(s) completed by an Elite Sports Medicine doctor, Adolescents aged 12 to 18 at the time of surgery, Post-primary ACL reconstruction, Completion of postoperative rehab according to standard protocols, No impediments preventing Blood Flow Restriction (BFR), as outlined in Owens Recovery Science 2018's BFR manual."

Answered by AI

What is the purpose of this clinical research endeavor?

"The primary assessment of this clinical trial over a three-phase period (pre-operative, 3 months post-op, and 6 to 9 months post-op) is the Isometric Hamstring Strength Limb Symmetry Index. Secondary outcomes include the ACL Return to Sport after Injury score (ACL RSI; 0 - 100; higher scores representing greater preparedness for sports), Knee Outcomes and Osteoarthritis Scale percentage score (KOOS: 0 - 100 with 0 indicating severe issues and 100 denoting no difficulties), as well as Marx Activity Rating Scale which gauges running, cutting, deceleration, and"

Answered by AI

Does this research have an age restriction, and if so, what is it?

"The parameters of this medical research project necessitate that participants are aged between 12 and 18. Additionally, there are 47 clinical trials for minors and 27 experiments catering to those over 65 years old."

Answered by AI

Are there still opportunities available to participate in this research endeavor?

"Per the information on clinicaltrials.gov, this research project is no longer accepting participants at present. It was initially posted on January 15th 2020 and underwent its last edit in March 30 2022. While currently inactive, there are 105 other trials actively recruiting patients right now."

Answered by AI
~12 spots leftby Mar 2025