Blood Flow Restriction Training After Patellar INStability
Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)
Caitlin Conley
78 participants
Sep 9, 2020
INTERVENTIONAL
Conditions
Summary
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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
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Interventions
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04554212