105 Participants NeededMy employer runs this trial

Blood Flow Restriction Therapy for Postoperative Rehabilitation After Ankle Surgery

(BFRankle recon Trial)

Recruiting at 4 trial locations
EH
JH
Overseen ByJenny Hudnall, MS BME
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Texas Tech University Health Sciences 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 explores a new method to aid recovery after ankle surgery using blood flow restriction (BFR) therapy. BFR applies pressure to reduce blood flow during physical therapy sessions, potentially aiding muscle recovery and strength. The trial compares BFR to standard physical therapy to determine which method more effectively reduces muscle loss and pain. Ideal candidates for this trial have undergone ankle ligament reconstruction surgery and can commit to at least six weeks of physical therapy. As an unphased trial, this study offers a unique opportunity to explore innovative recovery methods that could enhance the rehabilitation experience.

Will I have to stop taking my current medications?

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 blood flow restriction therapy is safe for postoperative rehabilitation?

Research has shown that Blood Flow Restriction (BFR) therapy is generally safe for recovery after surgery. Studies have found that BFR can increase muscle strength and size after orthopedic surgery, even with light weights, and it is usually well-tolerated by patients.

One review found BFR to be a safe addition to regular therapy, especially post-surgery. Another study reported no serious side effects, although it wasn't specifically designed to detect rare problems. Overall, patients have responded well to BFR, showing improvements in muscle strength and recovery without major risks.

For those considering joining a trial for BFR therapy, evidence suggests it is a safe option to aid recovery after surgery.12345

Why are researchers excited about this trial?

Blood Flow Restriction (BFR) Therapy is unique because it offers a novel approach to rehabilitation after ankle surgery by incorporating a device that restricts blood flow during physical therapy. Unlike the standard care, which involves regular physical therapy sessions, BFR enhances muscle strength and recovery by creating a low-oxygen environment, which stimulates muscle growth and repair more effectively. Researchers are excited about this technique because it could potentially speed up recovery times and improve outcomes for patients by maximizing the benefits of physical therapy without increasing physical strain.

What evidence suggests that blood flow restriction therapy is effective for postoperative rehabilitation after ankle surgery?

Research has shown that Blood Flow Restriction (BFR) therapy aids recovery after surgery. Studies have found that BFR increases muscle strength and stability, crucial for healing. For example, BFR can enhance muscle strength even with light exercise, enabling patients to build strength without overstraining their recovering bodies. In this trial, participants in the Blood Flow Restriction (BFR) group will use a BFR device during physical therapy, while the Standard of Care (SOC) group will follow the standard physical therapy course without BFR. Patients using BFR have experienced better pain relief and overall recovery improvements. While some studies suggest benefits for increasing muscle size and reducing pain, the overall evidence supports BFR as a promising option for enhancing recovery after surgery.13467

Who Is on the Research Team?

JG

Jerry Grimes, MD

Principal Investigator

Texas Tech University Health Sciences Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have recently had ankle ligament reconstruction surgery and can pay for or have insurance covering at least 6 weeks of physical therapy.

Inclusion Criteria

I am between 18 and 65 years old.
I have had ankle ligament reconstruction surgery.
I can pay for or have insurance for at least 6 weeks of physical therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Recovery

Participants recover from ankle ligament reconstruction surgery before starting physical therapy

4 weeks

Treatment

Participants receive physical therapy with or without blood flow restriction (BFR) for rehabilitation

6 weeks
Weekly PT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Flow Restriction Therapy

Trial Overview

The study compares standard physical therapy to physical therapy with blood flow restriction (BFR) after ankle ligament surgery. Participants are randomly assigned to either group, and outcomes like muscle strength, pain, and ankle function are measured over at least 6 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Blood flow restriction (BFR) groupExperimental Treatment1 Intervention
Group II: Standard of Care (SOC) groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials
107
Recruited
11,500+

The Center for Orthopedic Surgery

Collaborator

UMC Health System

Collaborator

H2 Health (Physical Therapy Today)

Collaborator

Northstar Surgery Center

Collaborator

Citations

NCT07451210 | Evaluating the Efficacy of Blood Flow ...

This study is designed as a randomized clinical trial to evaluate the efficacy of Blood Flow Restriction (BFR) therapy in postoperative rehabilitation following ...

Effect of blood flow restriction on muscle strength and stability ...

Preliminary evidence has shown that blood flow restriction (BFR) rehabilitation can increase muscle strength and stability, helping to restore ...

Blood Flow Restriction Therapy for Postoperative ...

Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention.

Effect of blood flow restriction training in early postoperative ...

The findings of the present study demonstrate that both interventions resulted in significant improvements over time in subjective pain, muscle ...

Evaluating the Efficacy of Blood Flow Restriction Therapy in a ...

Study Aims: To evaluate the efficacy of Blood Flow Restriction (BFR) therapy compared to the current standard of care (SOC) in improving muscle ...

The Role of Blood Flow Restriction Therapy in Postop ...

We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post- ...

Blood flow restriction training in post-operative orthopedic ...

This review shows that BFRT is generally safe. It can improve muscle strength and size after orthopedic surgery, even with low loads. The ...