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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I completed orthopedic surgery and physical therapy at Connecticut Children's.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Isokinetic Hamstring Strength limb symmetry index
Isokinetic Hamstrings Strength
Isokinetic Quadriceps Strength limb symmetry index
+6 moreSecondary outcome measures
Anterior Cruciate Ligament- Return to Sport after Injury
Knee Outcomes and Osteoarthritis Scale
Pediatric International Knee Documentation Committee
+2 moreTrial 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
Find a Location
Who is running the clinical trial?
Connecticut Children's Medical CenterLead Sponsor
71 Previous Clinical Trials
31,474 Total Patients Enrolled
University of ConnecticutOTHER
184 Previous Clinical Trials
158,253 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
129 Patients Enrolled for Anterior Cruciate Ligament Injury
Adam Weaver, PT, DPTPrincipal InvestigatorPhysical Therapist
1 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot attend most of my physical therapy sessions.Before surgery, you participated in more than 50 hours per year of intense sports and plan to go back to that level after the surgery.I completed orthopedic surgery and physical therapy at Connecticut Children's.I must limit putting weight on my leg for over 4 weeks after surgery due to other knee issues.I have another leg injury or had surgery on either knee.I am scheduled for or have had surgery that might require follow-up for stiffness.I do not have neurological, heart conditions, or a history of DVT that would prevent BFRT.I have had multiple ligament injuries.I have finished my post-surgery rehab according to the standard plan.
Research Study Groups:
This trial has the following groups:- Group 1: BFR Intervention Group
- Group 2: No Intervention/Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the criteria to participate in this research?
"In order to join this research, individuals must have suffered an injury involving the knee and be within the age range of 12-18. 40 participants are required for successful completion of the trial."
Answered by AI
Are there any opportunities to join this medical research project at present?
"According to the records on clinicaltrials.gov, this study is not presently enrolling patients. Initially listed on March 1st of 2023 and last updated February 22nd, there are no further openings at present; however, 928 other trials are currently seeking participants."
Answered by AI
Is the age cutoff for this research project below 45 years?
"This clinical trial has narrowed its focus to participants aged 12-18, with 208 studies conducted for people of that age group and 669 studies focusing on those over 65."
Answered by AI
What is the intention behind this trial?
"The primary outcome measured over a period from pre-op to 9 months post-op is Isometric Quad strength Peak Torque. Further, the trial will also evaluate secondary outcomes like Pediatric International Knee Documentation Committee (a score ranging from 0 points for lowest level of function or highest level of symptoms to 100 points for best performance and least amount of distress), Knee Outcomes and Osteoarthritis Scale (percentage scores between 0 - 100 with higher numbers indicating less difficulty) and Anterior Cruciate Ligament Return to Sport after Injury scale (scores range between 0 -100 where high values represent readiness)."
Answered by AI
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