NCT04554212 Blood Flow Restriction Training After Patellar INStability
| NCT ID | NCT04554212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Caitlin Conley |
| Condition | Patellar Dislocation |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2020-09-09 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2020-09-09 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Caitlin Conley, PhD
STUDY DIRECTOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT04554212 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 40 Years, studying Patellar Dislocation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04554212 currently recruiting?
Yes, NCT04554212 is actively recruiting participants. Contact the research team at caitlin.conley2@uky.edu for enrollment information.
Where is the NCT04554212 trial being conducted?
This trial is being conducted at Lexington, United States, Lexington, United States, Foxborough, United States, Foxborough, United States.
Who is sponsoring the NCT04554212 clinical trial?
NCT04554212 is sponsored by Caitlin Conley. The principal investigator is Caitlin Conley, PhD at University of Kentucky. The trial plans to enroll 78 participants.