← Back to Search

BFR Therapy for ACL Reconstruction Rehab

N/A
Recruiting
Led By Andrew J Sheean, MD
Research Sponsored by Brooke Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
15 to 45 years of age
Indicated for ACL reconstruction with quadriceps tendon autograft with evidence of skeletal maturity; no open physes/growth plates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: pre-operatively] [time frame: 6 months post-operatively] [time frame: 9 months post-operatively] [time frame: 12 months post-operatively]
Awards & highlights

Study Summary

This trial will investigate whether adding BFR therapy to standard post-op rehab for ACLR can improve outcomes. Patients will get MRI scans and PRO instruments at different points in the trial.

Who is the study for?
This trial is for active duty members or beneficiaries of the Department of Defense Military Health System, aged 15-45, who need ACL reconstruction with quadriceps tendon autograft and have mature skeletons. Excluded are those needing other surgeries affecting mobility, unable to follow rehab consistently, can't get MRIs due to intolerance/device interference, having multiple knee ligament reconstructions or recent leg vein clots.Check my eligibility
What is being tested?
The study tests if adding Blood Flow Restriction (BFR) therapy to standard post-op rehab improves outcomes after ACL surgery using a quadriceps tendon graft. Participants will be randomly assigned to either standard rehab or rehab plus BFR and monitored through MRI at different stages and patient-reported outcome tools over one year.See study design
What are the potential side effects?
Potential side effects from BFR therapy may include discomfort in the limb due to restricted blood flow during exercise sessions. Standard rehabilitation risks include muscle soreness and joint stiffness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 15 and 45 years old.
Select...
I need ACL surgery using my own tissue and my bones have finished growing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame: pre-operatively] [time frame: 6 months post-operatively] [time frame: 9 months post-operatively] [time frame: 12 months post-operatively]
This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame: pre-operatively] [time frame: 6 months post-operatively] [time frame: 9 months post-operatively] [time frame: 12 months post-operatively] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Knee extensor strength
Quadriceps CSA MRI
Secondary outcome measures
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) (Short version 6Q)
Connor-Davidson Resilience Scale (CD-RISC)
Patient Reported Outcome - International Knee Documentation Committee Form (IKDC)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: REHAB + BFRExperimental Treatment2 Interventions
Standard rehabilitation regimen with BFR therapy (REHAB + BFR) (Experimental)
Group II: REHABExperimental Treatment1 Intervention
Standard post-operative rehabilitation regimen (REHAB) (Control)

Find a Location

Who is running the clinical trial?

Congressionally Directed Medical Research ProgramsFED
48 Previous Clinical Trials
6,716 Total Patients Enrolled
American Orthopaedic Society for Sports MedicineOTHER
6 Previous Clinical Trials
1,197 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
169 Patients Enrolled for Anterior Cruciate Ligament Injury
Brooke Army Medical CenterLead Sponsor
119 Previous Clinical Trials
26,499 Total Patients Enrolled

Media Library

Standard REHAB Clinical Trial Eligibility Overview. Trial Name: NCT04519801 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: REHAB, REHAB + BFR
Anterior Cruciate Ligament Injury Clinical Trial 2023: Standard REHAB Highlights & Side Effects. Trial Name: NCT04519801 — N/A
Standard REHAB 2023 Treatment Timeline for Medical Study. Trial Name: NCT04519801 — 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 become a participant in this experiment?

"Eligibility criteria for this research project requires that prospective participants possess a tear of the anterior cruciate ligament and be between 15 to 45 years old. There are 60 available spots in total."

Answered by AI

What is the current count of participants in this experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, initiated in September 9th 2022, is actively searching for participants. The researchers are aiming to enrol 60 individuals at a single medical centre."

Answered by AI

Is this examination available to individuals of forty years or older?

"To be eligible for this research, participants must fall in the 15-45 age range. There are 53 trials available to those younger than 15 and 26 clinical studies for seniors aged 65 or older."

Answered by AI

Is the enrollment phase of this trial still ongoing?

"Yes, the analysis on clinicaltrials.gov verifies that this trial is actively recruiting for participants, having been posted in September 9th 2022 and lastly updated July 31st 2023. The research study intends to recruit 60 individuals from 1 particular site."

Answered by AI

What is the primary intent of this investigation?

"The primary outcome evaluated in this trial over a 7-10 day, 12 week, 24 week, 36 week and 52 weeks time frame is the Quadriceps CSA MRI. Secondary outcomes measured include Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) instrument which gauges patients' emotions and sentiments when returning to sports following an ACL injury or reconstructive surgery via visual analogue scale from 0 - 100 points; Knee osteoarthritis Outcome Score (KOOS), comprising 42 items with 5 subscales for pain symptoms, daily living functioning, sport/recreation function and knee quality"

Answered by AI
Recent research and studies
~8 spots leftby Aug 2024