BFR Therapy for ACL Reconstruction Rehab

DJ
AJ
Overseen ByAndrew J Sheean, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Brooke Army Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding blood flow restriction (BFR) therapy to standard rehabilitation improves recovery after anterior cruciate ligament (ACL) surgery. Participants are divided into two groups: one receives standard rehabilitation, while the other receives standard rehabilitation plus BFR therapy. The trial targets active duty or Department of Defense beneficiaries who require ACL reconstruction using their own quadriceps tendon and have no growth plate issues. As an unphased trial, it provides a unique opportunity to explore innovative recovery methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that BFR therapy is safe for ACL reconstruction rehab?

Research has shown that blood flow restriction (BFR) therapy is generally safe for individuals recovering from ACL (anterior cruciate ligament) surgery. Studies have found that patients not only find BFR therapy safe but also well-received. Many patients express satisfaction with this therapy when combined with light exercises.

Although BFR therapy might not immediately enhance muscle strength, it can help maintain muscle and bone health after ACL surgery. No major safety issues have been reported, making it a promising option for those seeking to improve their recovery after ACL reconstruction.12345

Why are researchers excited about this trial?

Unlike the standard of care for ACL reconstruction rehabilitation, which involves traditional physical therapy exercises, BFR (Blood Flow Restriction) therapy is gaining attention for its unique approach. BFR therapy works by partially restricting blood flow to the muscles during low-intensity exercise, which can enhance muscle strength and recovery more efficiently. Researchers are excited because this method may accelerate rehabilitation, allowing patients to regain function faster than with standard rehab alone. Plus, it could reduce the overall stress on healing tissues, potentially leading to safer recovery outcomes.

What evidence suggests that BFR therapy is effective for ACL reconstruction rehab?

Research has shown that Blood Flow Restriction (BFR) therapy might aid recovery after ACL surgery. In this trial, participants will receive either the standard post-operative rehabilitation regimen (REHAB) or the standard regimen with BFR therapy (REHAB + BFR). Some studies have found that BFR can increase thigh muscle strength, which is crucial for rehabilitation. However, other research suggests that BFR is not always superior to regular therapy. Some patients using BFR have reported less pain and improved knee function. Overall, while BFR therapy appears promising, results can vary among individuals.12367

Who Is on the Research Team?

AJ

Andrew J Sheean, MD

Principal Investigator

Brooke Army Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 15 and 45 years old.
I need ACL surgery using my own tissue and my bones have finished growing.
Active duty member or Department of Defense Military Health System beneficiary

Exclusion Criteria

I cannot follow the required rehab plan after surgery.
Patients that are unable to obtain MRI secondary to either intolerance and/or implanted medical devices that preclude the safe completion of the MRI.
I haven't had a deep vein clot in my leg, surgery on leg lymph nodes, or blood vessel issues in the past year.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Pre-operative Assessment

MRI of bilateral thighs and isokinetic and isometric strength measurements are performed to establish baseline

1 week
1 visit (in-person)

Treatment

Participants undergo ACL reconstruction surgery followed by a 12-week post-operative rehabilitation regimen with or without BFR therapy

12 weeks
Weekly visits (in-person)

Mid-term Follow-up

Patient reported outcomes and MRI assessments at 24 and 36 weeks post-operative to monitor progress

24 weeks
2 visits (in-person)

Long-term Follow-up

Final assessments including MRI and patient reported outcomes at 52 weeks post-operative to evaluate long-term effects

16 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Flow Restriction (BFR) therapy
  • Standard REHAB
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: REHAB + BFRExperimental Treatment2 Interventions
Group II: REHABExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials
134
Recruited
28,100+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

American Orthopaedic Society for Sports Medicine

Collaborator

Trials
8
Recruited
2,100+

Citations

Outcomes of Blood Flow Restriction Training After ACL ...Although the data are limited, BFRT has been shown to be safe and potentially effective in improving quadriceps muscle strength in patients with ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39350350/
The Efficacy of Blood Flow Restriction Training to Improve ...Conclusions: The addition of BFRT to a rehabilitation program for athletes pre- and post-ACLR was no more effective than standard rehabilitation ...
Blood Flow Restriction Enhances Recovery After Anterior ...The use of BFR after ACLR led to improvements in pain, IKDC score, and isokinetic muscle strength, with variable outcomes based on quadriceps strength, volume, ...
The effects of blood flow restriction training on early muscle ...BFRT demonstrated limited effectiveness in early muscle strength recovery during ACLR rehabilitation but may have a positive impact on mid-term knee function.
Blood Flow Restriction Therapy Prior to Anterior Cruciate ...A recent research study showed that blood flow restriction (BFR) therapy was safe and well tolerated but failed to demonstrate efficacy.
A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD ...Blood flow restriction therapy preserves whole limb bone and muscle following ACL reconstruction. Orthop J Sports Med. 2019;7(3_suppl2):2325967119S00196 ...
Qualitative Evaluation of Patient Experiences with Low-Load ...This qualitative study showed high patient satisfaction with low-load blood flow restriction training (LL-BFRT) and heavy-load resistance ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security