Blood flow Restriction training After patellar INStability (BRAINS Trial).
Benjamin D Brightwell, Austin Stone, Xiaojuan Li...
https://pubmed.ncbi.nlm.nih.gov/35090543/Actively Recruiting
Led by Caitlin Conley · Updated on 2025-07-03
78
Participants Needed
4
Research Sites
N/A
Total Duration
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 BFRTs 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
C
Caitlin Conley, PhD
N
Natalie Corey
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Caitlin Conley
Lead Sponsor
The Cleveland Clinic
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | PT + BFRT | PT + Sham BFRT | Usual Care PT |
|---|---|---|---|
| What it is | Standard physical therapy plus blood flow restriction training using thigh cuff during rehabilitation | Standard physical therapy plus sham blood flow restriction training with minimal cuff inflation | Physical therapy without blood flow restriction is the standard conservative care for patellar instability |
| Role in trial | Experimental arm being tested for added benefit of BFRT | Control arm using sham BFRT to blind participants to BFRT effects | Represents common rehabilitation practice lacking BFRT component |
| Primary use | Restore strength and function after patellar instability, potentially enhancing outcomes via BFRT | Identify whether effects are due to BFRT versus placebo effects | Rehabilitative approach aiming to regain knee stability and function after patellar instability |
| How it is done | Therapy sessions include standard PT plus thigh cuff inflated to around 60% arterial occlusion during exercises | Therapy sessions include standard PT plus sham cuff inflated to under 10% occlusion | Typical physical therapy includes strengthening, ROM exercises, neuromuscular control and functional drills per rehabilitation guidelines |
| Evidence status | Effectiveness under investigation; no outcomes available yet | Placebo-like comparator; efficacy distinguishing from sham under study | Supported as standard conservative management for patellar instability, though high-quality evidence remains limited |
| Important limitations | No outcome data yet; unknown if BFRT improves long‑term function or cartilage health | Sham control may influence expectations; efficacy of sham versus BFRT remains untested | Standard PT approaches vary widely and lack high‑level evidence for optimal protocols |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Benjamin D Brightwell, Austin Stone, Xiaojuan Li...
https://pubmed.ncbi.nlm.nih.gov/35090543/Caitlin Conley
Lead Sponsor
The Cleveland Clinic
Collaborating Sponsor