Wounds and Injuries Clinical Trial
— BRAINSOfficial title:
Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)
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.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UK Healthcare at Turfland | Lexington | Kentucky |
United States | University of Kentucky Biomotion Laboratory | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Caitlin Conley | The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Norwich Patellar Instability Scale | The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability | Baseline | |
Primary | The Norwich Patellar Instability Scale | The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability | 5 Weeks | |
Primary | The Norwich Patellar Instability Scale | The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability | 9 Weeks | |
Primary | The Norwich Patellar Instability Scale | The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability | 6 Months | |
Primary | The Norwich Patellar Instability Scale | The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability | 12 Months | |
Primary | Quadriceps Strength Symmetry | Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences. | 1 Week | |
Primary | Quadriceps Strength Symmetry | Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences. | 5 Weeks | |
Primary | Quadriceps Strength Symmetry | Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences. | 9 Weeks | |
Primary | Quadriceps Strength Symmetry | Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences. | 6 Months | |
Primary | Quadriceps Strength Symmetry | Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences. | 12 Months | |
Primary | MRI T1rho | Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers. | 1 Week | |
Primary | MRI T1rho | Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers. | 12 Months | |
Secondary | MRI Muscle Volume | Quadriceps muscle volume (cm2) | 12 Months | |
Secondary | The Norwich Patellar Instability Scale | The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability | 24 Months | |
Secondary | Quadriceps Strength Symmetry | Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences. | 24 Months | |
Secondary | MRI Muscle Volume | Quadriceps muscle volume (cm2) | 24 Months | |
Secondary | MRI T1rho | Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers. | 24 Months |
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