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Blood Flow Restriction Training After Patellar INStability (BRAINS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04554212
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Cale Jacobs, PhD, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Patellar Dislocation Knee Injuries Leg Injury Wounds and Injuries Device: Blood Flow Restriction Training Device: Sham Blood Flow Restriction Training Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Active Comparator: Standard Physical Therapy with Sham BFRT
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
Device: Sham Blood Flow Restriction Training
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.

Active Comparator: Standard Physical Therapy with BFRT
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
Device: Blood Flow Restriction Training
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554212


Contacts
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Contact: Cale Jacobs, PhD 8597978197 cale.jacobs@uky.edu

Locations
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United States, Kentucky
UK Healthcare at Turfland Recruiting
Lexington, Kentucky, United States, 40504
Contact: Cale Jacobs, PhD    859-797-8197    cale.jacobs@uky.edu   
University of Kentucky Biomotion Laboratory Recruiting
Lexington, Kentucky, United States, 40536
Contact: Brian Noehren, PhD, PT    859-218-0581    b.noehren@uky.edu   
Sponsors and Collaborators
Cale Jacobs, PhD
The Cleveland Clinic
Investigators
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Study Director: Cale Jacobs University of Kentucky
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Responsible Party: Cale Jacobs, PhD, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04554212    
Other Study ID Numbers: 56541
CDMRP-CDMRP-PR191214 ( Other Grant/Funding Number: Department of Defense )
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Patellar Dislocation
Wounds and Injuries
Knee Injuries
Leg Injuries
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases