Recruiting

Blood Flow Restriction Training

Sponsor:

Caitlin Conley

Code:

NCT04554212

Conditions

Patellar Dislocation

Knee Injuries

Leg Injury

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

Interventions

Blood Flow Restriction Training

Sham Blood Flow Restriction Training

Study Details

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.

Conditions

Patellar Dislocation

Knee Injuries

Leg Injury

Wounds and Injuries

Study ID

NCT04554212

Start date

Sep 9, 2020

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Physical Therapy with Sham BFRT

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

active comparator: Standard Physical Therapy with BFRT

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

Interventions

Blood Flow Restriction Training

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

Sham Blood Flow Restriction Training

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

Primary outcome measure

  • The Norwich Patellar Instability Scale [ Time Frame: Baseline ]
  • The Norwich Patellar Instability Scale [ Time Frame: 5 Weeks ]
  • The Norwich Patellar Instability Scale [ Time Frame: 9 Weeks ]
  • The Norwich Patellar Instability Scale [ Time Frame: 6 Months ]
  • The Norwich Patellar Instability Scale [ Time Frame: 12 Months ]
  • Quadriceps Strength Symmetry [ Time Frame: 1 Week ]
  • Quadriceps Strength Symmetry [ Time Frame: 5 Weeks ]
  • Quadriceps Strength Symmetry [ Time Frame: 9 Weeks ]
  • Quadriceps Strength Symmetry [ Time Frame: 6 Months ]
  • Quadriceps Strength Symmetry [ Time Frame: 12 Months ]
  • MRI T1rho [ Time Frame: 1 Week ]
  • MRI T1rho [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Caitlin Conley, PhD

8592571939caitlin.conley2@uky.edu

Natalie Corey

natalie.corey@uky.edu

Locations

UK Healthcare at Turfland

Recruiting

Lexington, Kentucky, United States, 40504

Contacts

Caitlin Conley, PhD

859-257-1939caitlin.conley2@uky.edu

University of Kentucky Biomotion Laboratory

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Brian Noehren, PhD, PT

8592180581b.noehren@uky.edu

Center for Sports Performance and Research

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Molly Zgoda

508-216-1145mzgoda@mgb.org

Foxboro Sports Medicine Clinic

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Cale Jacobs, PhD

508-216-1145.cjacobs@bwh.harvard.edu

Molly Zgoda

508-216-1145.mzgoda@mgb.org

More Information

Sponsor

Caitlin Conley

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Caitlin Conley on 2026-08-21.