Blood Flow Restriction Therapy for Lower Limb Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new therapy called blood flow restriction therapy, which uses a special cuff on the leg to limit blood flow, potentially improving strength and muscle mass in individuals with lower leg injuries like tendon ruptures. The study will compare this therapy to a placebo version to determine its effectiveness. Suitable candidates for this trial are those with a lower leg extensor injury who plan to undergo physical therapy.
As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for future patients.
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 lower limb injuries?
Research has shown that blood flow restriction therapy (BFRT) is generally well-tolerated. Studies have found that this therapy can improve muscle strength and reduce pain during recovery. For instance, one study found that it led to strength gains similar to those from traditional weightlifting, suggesting its safety.
While some discomfort from the cuff's pressure may occur, studies have not reported any serious side effects. The therapy involves placing a cuff around the leg to limit blood flow, but it is carefully controlled to prevent major issues. Overall, people handle this treatment well, and it could be a useful option for building strength after an injury.12345Why are researchers excited about this trial?
Unlike traditional treatments for lower limb injuries, which often involve physical therapy or surgery, blood flow restriction therapy (BFRT) uses a pressure cuff to limit blood flow to the injured area. This technique is unique because it allows for muscle strengthening and recovery with lower intensity exercises, which can be less taxing on the body. Researchers are excited about BFRT because it has the potential to accelerate rehabilitation times by enhancing muscle growth and strength without the need for heavy weights or strenuous activity. Additionally, the therapy's ability to specifically target the injured area with controlled pressure could lead to more efficient and effective recovery outcomes.
What evidence suggests that blood flow restriction therapy is effective for lower limb injuries?
Research has shown that blood flow restriction therapy can enhance muscle strength and size. This therapy uses a cuff to limit blood flow to the muscles, promoting growth even with lighter exercises. Evidence suggests it can also reduce pain and improve function more effectively than regular resistance training. In this trial, participants will receive either the experimental blood flow restriction therapy, which limits approximately 80% of arterial blood flow using a pressure cuff, or a placebo version with a lower pressure setting. For individuals with leg injuries, this method increased strength and reduced pain. In athletes, combining this therapy with other training led to greater muscle strength improvements. Overall, this approach has shown promise for muscle recovery and growth.12467
Who Is on the Research Team?
Guillem Gonzales-Lomas, MD
Principal Investigator
NYU Langone
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with lower limb extensor injuries who plan to undergo physical therapy. It's not suitable for those under 18 or over 65, mentally impaired individuals, people using mobility aids before injury, patients with prior similar injuries, circulation issues, severe hypertension, additional leg trauma, sickle cell anemia, venous thromboembolism or cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo blood flow restriction therapy with a pressure cuff to enhance muscle hypertrophy and rehabilitation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blood Flow Restriction Therapy
Blood Flow Restriction Therapy is already approved in United States, Japan, European Union for the following indications:
- Musculoskeletal injuries
- Pre-surgical strengthening
- Post-surgical rehabilitation
- Arthritis
- Tendinitis
- Non-union fractures
- IT band issues
- Muscle hypertrophy
- Muscle strengthening
- Rehabilitation after injury or surgery
- Orthopedic rehabilitation
- Muscle strengthening
- Pain relief
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor