← Back to Search

Blood Flow Restriction Training for ACL Reconstruction Recovery

N/A

Recruiting

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

Orthopedic surgical intervention and physical therapy completed at Connecticut Children's

Be younger than 65 years old

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in strength at pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate if adding a BFRT-based exercise program to a standard ACLR rehab protocol improves outcomes in adolescents.

Who is the study for?

This trial is for adolescents who have had ACL reconstruction and were active in sports before their injury. They must have completed surgery and physical therapy at Connecticut Children's, following standard protocols, without other major knee injuries or surgeries, weight bearing restrictions over 4 weeks due to additional pathology, or follow-up procedures like arthrofibrosis.

What is being tested?

The study tests if adding Blood Flow Restriction Training (BFRT) using the Delfi Personalized Tourniquet System to standard ACL rehab improves strength, muscle growth, and patient outcomes in adolescents after ACL reconstruction compared to just the standard rehab protocol.

What are the potential side effects?

Potential side effects of BFRT may include discomfort from the tourniquet system used to restrict blood flow during exercise. There could also be risks related to exacerbation of existing conditions such as neurologic impairments or a history of deep vein thrombosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I completed orthopedic surgery and physical therapy at Connecticut Children's.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot attend most of my physical therapy sessions.

Select...

I do not have neurological, heart conditions, or a history of DVT that would prevent BFRT.

Select...

I must limit putting weight on my leg for over 4 weeks after surgery due to other knee issues.

Select...

I have another leg injury or had surgery on either knee.

Select...

I am scheduled for or have had surgery that might require follow-up for stiffness.

Select...

I have had multiple ligament injuries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in strength at pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in strength at pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in strength at pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Isokinetic Hamstring Strength limb symmetry index

Isokinetic Hamstrings Strength

Isokinetic Quadriceps Strength limb symmetry index

+6 more

Secondary study objectives

Anterior Cruciate Ligament- Return to Sport after Injury

Knee Outcomes and Osteoarthritis Scale

Pediatric International Knee Documentation Committee

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BFR Intervention GroupExperimental Treatment1 Intervention

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

Group II: No Intervention/Control GroupActive Control1 Intervention

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

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

0 / 7Eligibility criteria met