RecruitingNot ApplicableNCT04554212

Blood Flow Restriction Training After Patellar INStability

Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)


Sponsor

Caitlin Conley

Enrollment

78 participants

Start Date

Sep 9, 2020

Study Type

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

Min Age: 14 YearsMax Age: 40 Years

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

DEVICEBlood Flow Restriction Training

Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.

DEVICESham Blood Flow Restriction Training

Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.


Locations(4)

UK Healthcare at Turfland

Lexington, Kentucky, United States

University of Kentucky Biomotion Laboratory

Lexington, Kentucky, United States

Center for Sports Performance and Research

Foxborough, Massachusetts, United States

Foxboro Sports Medicine Clinic

Foxborough, Massachusetts, United States

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NCT04554212


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