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Behavioural Intervention

Blood Flow Restriction Training for Knee Instability (BRAINS Trial)

N/A

Recruiting

Research Sponsored by Caitin Conley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Skeletally mature with closed growth plates visualized by radiograph

Age 14 to 40 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

BRAINS Trial Summary

This trial will study whether blood flow restriction training can improve knee instability.

Who is the study for?

This trial is for individuals aged 14-40 with closed growth plates and traumatic patellar instability, who are active in sports like tennis or skiing at least once a week. They must want to return to their pre-injury activity level. Excluded are those with certain knee conditions, surgeries, high BMI (>35), varicose veins, history of deep vein thrombosis in the family, planned long absences during the trial period, diabetes or uncontrolled hypertension.Check my eligibility

What is being tested?

The study tests blood flow restriction training (BFRT) against sham BFRT to see if it helps recovery from patellar instability. Participants will be randomly assigned to either real BFRT or a placebo-like version without actual restriction to compare outcomes.See study design

What are the potential side effects?

Potential side effects may include discomfort due to restricted blood flow during training sessions and possible muscle fatigue post-training. There might also be risks associated with wearing the device used for restricting blood flow.

BRAINS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bones have finished growing, as confirmed by an X-ray.

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I am between 14 and 40 years old.

BRAINS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

MRI Muscle Volume

MRI T1rho

Quadriceps Strength Symmetry

+1 more

BRAINS Trial Design

2Treatment groups

Active Control

Group I: Standard Physical Therapy with Sham BFRTActive Control1 Intervention

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

Group II: Standard Physical Therapy with BFRTActive Control1 Intervention

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

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Caitin ConleyLead Sponsor

Cale Jacobs, PhDLead Sponsor

4 Previous Clinical Trials

60 Total Patients Enrolled

Caitlin ConleyLead Sponsor

Media Library

Leg Injury Research Study Groups: Standard Physical Therapy with Sham BFRT, Standard Physical Therapy with BFRT

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What types of individuals are most suitable for participating in this experiment?

"The criteria for joining this clinical trial is having patellar dislocation and being between 14 to 40 years of age. A total of 78 participants are required in order to progress with the study."

Answered by AI

How many participants have enrolled in this research endeavor?

"Affirmative. According to the clinicaltrials.gov page, this medical investigation is currently in need of participants and has been since September 9th 2020 (the date it was first posted). A total of 78 individuals are necessary for enrolment at two different healthcare centres."

Answered by AI

Are those of senior age excluded from participation in this experiment?

"This medical study requires that patients be aged between 14 and 40 to enroll. Additionally, there are 145 similar clinical studies for minors, as well as 625 trials open to participants over the age of 65."

Answered by AI

Has the FDA given clearance to Knee Aspiration, Sham BFRT?

"As this is a Phase 2 trial, which implies that there are data backing the safety of Knee Aspiration, Sham BFRT but no evidence to support its efficacy yet, we have rated it with a score of two."

Answered by AI

Is this trial currently open to new enrollees?

"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively seeking participants and was first posted in September 2020 with its most recent update being on 12th of that same month. 78 individuals are wanted for enrollment from 2 separate sites."

Answered by AI

Recent research and studies

TrialsJournal

Blood Flow Restriction Training After Patellar Instability (BRAINS Trial)

Brightwell, Benjamin D., Austin Stone, Xiaojuan Li, Peter Hardy, Katherine Thompson, Brian Noehren, and Cale Jacobs. 2022. “Blood Flow Restriction Training After Patellar Instability (BRAINS Trial)”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06017-1.

clinicaltrials.govStudy

Blood Flow Restriction Training After Patellar INStability

Caitlin Conley 2020. "Blood Flow Restriction Training After Patellar INStability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04554212.

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