Improving recovery from patellar instability with blood flow restriction training
Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 14 Years to 40 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 4 sites (Lexington, Kentucky and 3 other locations) |
| Trial ID | NCT04554212 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with significant knee conditions such as osteochondral lesions or advanced osteoarthritis may not benefit from this study.
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 performed: Previous studies have shown promising results with blood flow restriction training in various rehabilitation contexts, suggesting potential for success in this application.
Eligibility criteria
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 this trial is running
Lexington, Kentucky and 3 other locations
- 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
- Study coordinator: Caitlin Conley, PhD
- Email: caitlin.conley2@uky.edu
- Phone: 8592571939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.