Actively Recruiting

Phase Not Applicable
Age: 14Years - 40Years
All Genders
ID04554212

Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)

Led by Caitlin Conley · Updated on 2025-07-03

78

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Caitlin Conley

Lead Sponsor

T

The Cleveland Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research study investigates whether a new type of physical therapy called blood flow restriction training (BFRT) can improve recovery for people with patellar instability, a condition involving knee dislocation or injury. The study is designed to answer important questions about BFRT's role in rehabilitation by comparing it with standard physical therapy. Participants eligible for the study are aged 14 to 40 years and have a diagnosis of traumatic patellar instability confirmed by a qualified medical professional. Participants are randomly assigned to one of two groups: standard physical therapy alone or standard physical therapy combined with BFRT. BFRT involves using an air cuff inflated around the thigh to limit blood flow during a standardized exercise program, lasting 8 weeks. Physical therapy may include exercises to improve knee strength, hip strength, gait training, and other supportive activities. Both groups receive close monitoring to ensure safety throughout treatment. Participants will attend multiple study visits over two years, starting with screening and enrollment, followed by strength testing, biomechanical assessments, questionnaires, blood and urine sample collection, and MRI scans. These visits occur at 1 week, 5 weeks, 9 weeks, 6 months, 1 year, and 2 years after enrollment. Throughout the study, researchers will measure knee function, strength symmetry, pain levels, and muscle health using tools like the Norwich Patellar Instability Scale and MRI imaging to assess recovery progress.

CONDITIONS

Brief Title

Blood Flow Restriction Training After Patellar INStability

Who Can Participate

Age: 14Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of traumatic patellar instability confirmed by a qualified physician or physical therapist
  • Age between 14 and 40 years
  • Skeletally mature with closed growth plates confirmed by X-ray
  • Score of 80 or more on the Sports Activity Scale indicating regular running, twisting, or turning activities
  • Desire to return to pre-injury activity level
Not Eligible

You will not qualify if you...

  • Osteochondral lesion requiring surgical fixation
  • Radiographic evidence of osteoarthritis (less than Kellgren-Lawrence Grade 2)
  • Previous knee surgery on either leg
  • Most recent instability event occurred more than 3 months before enrollment
  • History of any inflammatory disorder
  • Body mass index over 35 kg/m2
  • Diabetes or uncontrolled high blood pressure
  • Varicose veins or personal or immediate family history of deep vein thrombosis
  • Conditions or previous surgeries affecting ability to walk
  • Planned trips or vacations preventing attendance at 4 consecutive physical therapy sessions

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - 8 weeks

Participants undergo 8 weeks of physical therapy, either standard physical therapy alone or combined with blood flow restriction training using an air cuff inflated around the thigh to help recover strength.

Physical therapy sessions scheduled according to standard of care; strength testing and MRI assessments occur during this period

Follow-up

Duration - Up to 2 years after treatment

Participants are monitored with periodic strength testing, biomechanical assessments, questionnaires, lab specimen collections, and MRI scans to evaluate recovery and long-term outcomes.

Visits at 1 week, 5 weeks, 9 weeks, 6 months, 12 months, and 24 months with strength tests, biomechanics, questionnaires, lab tests, and MRIs

Trial Site Locations

Total: 4 locations

1

UK Healthcare at Turfland

Lexington, Kentucky, United States, 40504

Actively Recruiting

2

University of Kentucky Biomotion Laboratory

Lexington, Kentucky, United States, 40536

Actively Recruiting

3

Center for Sports Performance and Research

Foxborough, Massachusetts, United States, 02035

Actively Recruiting

4

Foxboro Sports Medicine Clinic

Foxborough, Massachusetts, United States, 02035

Actively Recruiting

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Research Team

C

Caitlin Conley, PhD

N

Natalie Corey

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial