Clinical trial Recruiting at 4 sites Interventional Ages 14 to 40

Improving recovery from patellar instability with blood flow restriction training

Official title: Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)

Run by University of Kentucky · NCT04554212 · Data updated 2026-11-12

This study is testing if adding blood flow restriction training to regular physical therapy can help people recover faster and get stronger after knee injuries caused by patellar instability.

Quick facts

Study typeInterventional
Ages14 Years to 40 Years
SexAll
Enrollment78 (estimated)
SponsorUniversity of Kentucky
Academic / other
Locations4 sites (Lexington, Kentucky and 3 other locations)
StatusRecruiting
StartedSeptember 9, 2020
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedAugust 21, 2026
Trial IDNCT04554212 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 14 to 40 with a diagnosis of traumatic patellar instability who wish to return to their pre-injury activity levels.

Probably not a fit

Patients with significant knee conditions such as osteochondral lesions or advanced osteoarthritis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research focuses on evaluating the effectiveness of blood flow restriction training (BFRT) in enhancing recovery for individuals suffering from patellar instability. Participants will be randomly assigned to either standard physical therapy or standard therapy combined with BFRT, which involves using an air cuff to temporarily limit blood flow to the thigh muscles. The study aims to determine if BFRT can accelerate strength recovery after knee injuries. Participants will be closely monitored throughout the treatment to ensure safety.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery times and outcomes for patients with patellar instability.

How similar studies have gone: Previous studies have shown promising results with blood flow restriction training in various rehabilitation contexts, suggesting potential for success in this application.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of traumatic patellar instability (either primary or recurrent) determined by an American Board of Family Medicine certified physician with a Certificate of Added Qualifications in Sports Medicine or licensed Physical Therapist utilizing clinical examination, radiographic imaging, and patients' reports of instability
* Age 14 to 40 years
* Skeletally mature with closed growth plates visualized by radiograph
* A score of 80 or more on the Sports Activity Scale, which corresponds to participating in "running, twisting, turning (tennis, racquetball, handball, ice hockey, field hockey, skiing, wrestling)" at least 1-3 times per week
* Desire to resume pre-injury activity level

Exclusion Criteria:

* Concomitant osteochondral lesion requiring surgical fixation
* Radiographic evidence of osteoarthritis (\< Kellgren-Lawrence Grade 2)
* Previous ipsilateral or contralateral knee surgery
* Most recent instability event more than 3 months before enrollment
* History of any inflammatory disorder
* BMI \> 35 kg/m2
* Diabetes or uncontrolled hypertension
* Varicose veins or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis
* Pre-existing conditions or previous surgeries that effect the ability to walk
* Planned trips or vacations that will result in the inability to attend 4 consecutive physical therapy sessions

Where it's running

  • UK Healthcare at Turfland
    Lexington, Kentucky, United States
    Recruiting
  • University of Kentucky Biomotion Laboratory
    Lexington, Kentucky, United States
    Recruiting
  • Center for Sports Performance and Research
    Foxborough, Massachusetts, United States
    Recruiting
  • Foxboro Sports Medicine Clinic
    Foxborough, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.