Patellar DislocationBRAINSNCT04554212
Blood Flow Restriction Training After Patellar INStability
A study testing Blood Flow Restriction Training in people with Patellar Dislocation and Knee Injuries, run by Caitlin Conley at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Patellar Dislocation, Knee Injuries, Leg Injury
- What is being tested?
- Blood Flow Restriction Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Sep 2020to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Natalie Corey contact
United States4 sites, 4 recruiting
- Recruiting
Center for Sports Performance and Research
Foxborough, Massachusetts, 02035
Molly Zgoda, 508-216-1145, mzgoda@mgb.org
- Recruiting
Foxboro Sports Medicine Clinic
Foxborough, Massachusetts, 02035
Cale Jacobs, PhD, 508-216-1145., cjacobs@bwh.harvard.edu
Molly Zgoda, 508-216-1145., mzgoda@mgb.org
- Recruiting
UK Healthcare at Turfland
Lexington, Kentucky, 40504
Caitlin Conley, PhD, 859-257-1939, caitlin.conley2@uky.edu
- Recruiting
University of Kentucky Biomotion Laboratory
Lexington, Kentucky, 40536
Brian Noehren, PhD, PT, 8592180581, b.noehren@uky.edu
About this study
Official 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.
Read the detailed description
Participants will randomly be assigned to 1 of 2 groups. This means that neither the participant or their doctor will not choose the treatment, but that the treatment will be randomly selected (like a coin toss). The study treatments is blood flow restriction training (BFRT). BFRT uses an air cuff that is inflated around the top of the thigh. This temporarily limits blood flow to the muscles and may allow the participant to recover strength more quickly after injury. As will be described later, the participant will be closely monitored during all study treatments to make sure they are as safe as possible.
The two groups that participants could be assigned to are:
- Standard physical therapy
- Standard physical therapy and BFRT
Physical Therapy Sessions: We are comparing two physical therapy interventions, one is the standard of care and the other is the standard of care plus an additional treatment. Participants have a 50/50 chance of receiving either treatment. If randomized to receive BFRT, the air cuffs will then be placed on the participants' thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed.
The following procedures may be performed. Some procedures may not be performed due to time constraints, availability of equipment, and/or by the decision of the investigator. Before initiating physical therapy, participants will be asked some questions including but not limited to the following: age, sex, level of activities, and expectations. Participants will also complete a Sports Activity Scale to determine their physical activity level.
Timeline of Study Visits:
Visit 1 Screening and enrollment: Upon arriving at the clinic or Biomotion Laboratory, potential subjects will have the following assessments: range of motion and knee instability, both of which are the standard of care for a patient with a suspected patellar instability.
After providing informed consent to participate in the study, we will ask you to provide a urine sample and will collect about 2 teaspoons of blood for laboratory testing. The blood will be collected from your arm using standard venipuncture. In addition, we will ask you questions about your medical history including current medications, demographic information, BMI, and smoking status. You will be asked to complete three study questionnaires: the Norwich Patella Instability Score which asks questions about your knee, the Cincinnati Occupational Rating Scale which asks questions about the physical demands of your job or daily life, and a Visual Analogue Scale that will ask you to rate your current pain. You will be randomized to either standard physical therapy or standard physical therapy with BFRT. You have a 50/50 chance of having BFRT. We will also schedule you to go to the BioMotion laboratory for baseline strength testing and to have your first study MRI at the MRISC.
Visit 2 (1 week)
- Knee and Hip Strength
- Walking Biomechanics
- MRI
Visit 3 (5 weeks)
- Knee and Hip Strength
- Questionnaires
Visit 4 (9 weeks)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking Biomechanics
- Questionnaires
Visit 5 (6 months)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking and Running Biomechanics
- Questionnaires
Visit 6 (1 year)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking, Running, and Jumping Biomechanics
- Questionnaires
- MRI
Visit 7 (2 years)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking, Running, and Jumping Biomechanics
- Questionnaires
- MRI
- Conditions
- Patellar Dislocation, Knee Injuries, Leg Injury, Wounds and Injuries
- Being tested
- Blood Flow Restriction Training, Sham Blood Flow Restriction Training
- Medical subject headings
- Patellar Dislocation, Knee Injuries, Leg Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TrainingDevice
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
Sham Blood Flow Restriction TrainingDevice
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physical Therapy with Sham BFRT | Active comparator | Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion. Receives: Device: Sham Blood Flow Restriction Training |
| Standard Physical Therapy with BFRT | Active comparator | Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion. Receives: Device: Blood Flow Restriction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: 5 Weeks
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
Measured: 9 Weeks
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
Measured: 6 Months
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
Measured: 12 Months
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.
Measured: 1 Week
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.
Measured: 5 Weeks
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.
Measured: 9 Weeks
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.
Measured: 6 Months
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.
Measured: 12 Months
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.
Measured: 1 Week
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.
Measured: 12 Months
Secondary outcomes (5)
MRI Muscle Volume
Quadriceps muscle volume (cm2)
Measured: 12 Months
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
Measured: 24 Months
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.
Measured: 24 Months
MRI Muscle Volume
Quadriceps muscle volume (cm2)
Measured: 24 Months
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start9 Sep 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caitlin Conley
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Caitlin Conley, University of Kentucky
- Investigators
- Caitlin Conley, PhD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554212
- Sponsor's protocol ID
- 56541
- Other IDs
- CDMRP-CDMRP-PR191214
- Acronym
- BRAINS
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brightwell BD, Stone A, Li X, Hardy P, Thompson K, Noehren B, Jacobs C. Blood flow Restriction training After patellar INStability (BRAINS Trial). Trials. 2022 Jan 28;23(1):88. doi: 10.1186/s13063-022-06017-1.
PubMed 35090543
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)
- ClinicalTrials.gov ID
- NCT04554212
- Acronym / sponsor ID
- BRAINS / 56541
- Conditions
- Patellar Dislocation, Knee Injuries, Leg Injury, Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Caitlin ConleyUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will randomly be assigned to 1 of 2 groups. This means that neither the participant or their doctor will not choose the treatment, but that the treatment will be randomly selected (like a coin toss). The study treatments is blood flow restriction training (BFRT). BFRT uses an air cuff that is inflated around the top of the thigh. This temporarily limits blood flow to the muscles and may allow the participant to recover strength more quickly after injury. As will be described later, the participant will be closely monitored during all study treatments to make sure they are as safe as possible.
The two groups that participants could be assigned to are:
- Standard physical therapy
- Standard physical therapy and BFRT
Physical Therapy Sessions: We are comparing two physical therapy interventions, one is the standard of care and the other is the standard of care plus an additional treatment. Participants have a 50/50 chance of receiving either treatment. If randomized to receive BFRT, the air cuffs will then be placed on the participants' thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed.
The following procedures may be performed. Some procedures may not be performed due to time constraints, availability of equipment, and/or by the decision of the investigator. Before initiating physical therapy, participants will be asked some questions including but not limited to the following: age, sex, level of activities, and expectations. Participants will also complete a Sports Activity Scale to determine their physical activity level.
Timeline of Study Visits:
Visit 1 Screening and enrollment: Upon arriving at the clinic or Biomotion Laboratory, potential subjects will have the following assessments: range of motion and knee instability, both of which are the standard of care for a patient with a suspected patellar instability.
After providing informed consent to participate in the study, we will ask you to provide a urine sample and will collect about 2 teaspoons of blood for laboratory testing. The blood will be collected from your arm using standard venipuncture. In addition, we will ask you questions about your medical history including current medications, demographic information, BMI, and smoking status. You will be asked to complete three study questionnaires: the Norwich Patella Instability Score which asks questions about your knee, the Cincinnati Occupational Rating Scale which asks questions about the physical demands of your job or daily life, and a Visual Analogue Scale that will ask you to rate your current pain. You will be randomized to either standard physical therapy or standard physical therapy with BFRT. You have a 50/50 chance of having BFRT. We will also schedule you to go to the BioMotion laboratory for baseline strength testing and to have your first study MRI at the MRISC.
Visit 2 (1 week)
- Knee and Hip Strength
- Walking Biomechanics
- MRI
Visit 3 (5 weeks)
- Knee and Hip Strength
- Questionnaires
Visit 4 (9 weeks)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking Biomechanics
- Questionnaires
Visit 5 (6 months)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking and Running Biomechanics
- Questionnaires
Visit 6 (1 year)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking, Running, and Jumping Biomechanics
- Questionnaires
- MRI
Visit 7 (2 years)
- Lab specimens collected (urine and about 2 teaspoons of blood)
- Knee and Hip Strength
- Walking, Running, and Jumping Biomechanics
- Questionnaires
- MRI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Physical Therapy with Sham BFRT | Active comparator | Device: Sham Blood Flow Restriction TrainingParticipants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion. |
| Standard Physical Therapy with BFRT | Active comparator | Device: Blood Flow Restriction TrainingParticipants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction TrainingParticipants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion. | Device | Standard Physical Therapy with BFRT |
| Sham Blood Flow Restriction TrainingParticipants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion. | Device | Standard Physical Therapy with Sham BFRT |
Primary outcome
The Norwich Patellar Instability Scale
Time frame: Baseline
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
The Norwich Patellar Instability Scale
Time frame: 5 Weeks
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
The Norwich Patellar Instability Scale
Time frame: 9 Weeks
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
The Norwich Patellar Instability Scale
Time frame: 6 Months
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
The Norwich Patellar Instability Scale
Time frame: 12 Months
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
Quadriceps Strength Symmetry
Time frame: 1 Week
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.
Quadriceps Strength Symmetry
Time frame: 5 Weeks
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.
Quadriceps Strength Symmetry
Time frame: 9 Weeks
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.
Quadriceps Strength Symmetry
Time frame: 6 Months
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.
Quadriceps Strength Symmetry
Time frame: 12 Months
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.
MRI T1rho
Time frame: 1 Week
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.
MRI T1rho
Time frame: 12 Months
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.
5 secondary outcomes
MRI Muscle Volume
Time frame: 12 Months
The Norwich Patellar Instability Scale
Time frame: 24 Months
Quadriceps Strength Symmetry
Time frame: 24 Months
MRI Muscle Volume
Time frame: 24 Months
MRI T1rho
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 35090543Brightwell BD, Stone A, Li X, Hardy P, Thompson K, Noehren B, Jacobs C. Blood flow Restriction training After patellar INStability (BRAINS Trial). Trials. 2022 Jan 28;23(1):88. doi: 10.1186/s13063-022-06017-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Corey contact
Caitlin Conley, PhD study director
University of Kentucky
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training in people with Patellar Dislocation and Knee Injuries, run by Caitlin Conley at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin Conley, PhD (8592571939, caitlin.conley2@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Norwich Patellar Instability Scale (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.