Blood flow Restriction training After patellar INStability (BRAINS Trial).
Benjamin D Brightwell, Austin Stone, Xiaojuan Li...
https://pubmed.ncbi.nlm.nih.gov/35090543Actively Recruiting
Led by Caitlin Conley · Updated on 2025-07-03
78
Participants Needed
4
Research Sites
N/A
Total Duration
C
Caitlin Conley
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
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
Blood Flow Restriction Training After Patellar INStability
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
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
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
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
C
Caitlin Conley, PhD
N
Natalie Corey
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Benjamin D Brightwell, Austin Stone, Xiaojuan Li...
https://pubmed.ncbi.nlm.nih.gov/35090543