Blood Flow Restriction Training After Patellar INStability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-40
SponsorCaitlin Conley
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Blood Flow Restriction Training
DeviceParticipants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
Sham Blood Flow Restriction Training
DeviceParticipants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Standard Physical Therapy with Sham BFRTActive comparator 1 intervention
Group B: Standard Physical Therapy with BFRTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline2
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
Time frame
5 Weeks3
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
Time frame
9 Weeks4
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
Time frame
6 MonthsSecondary outcomes
1
MRI Muscle Volume
Quadriceps muscle volume (cm2)
Time frame
12 Months2
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
Time frame
24 Months3
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.
Time frame
24 Months4
MRI Muscle Volume
Quadriceps muscle volume (cm2)
Time frame
24 MonthsSponsors and contacts
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Source ClinicalTrials.gov