Blood Flow Restriction Training After Patellar INStability

NCT04554212 | Recruiting DMC FDA Device

• 2 other identifiers: 56541CDMRP-CDMRP-PR191214
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

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.

Conditions

Patellar Dislocation; Knee Injuries; Leg Injury; Wounds and Injuries

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• MRI Muscle Volume

  12 Months

• The Norwich Patellar Instability Scale

  24 Months

• Quadriceps Strength Symmetry

  24 Months

• MRI Muscle Volume

  24 Months

• MRI T1rho

  24 Months

Study Arms (2)

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.

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.

Device: Blood Flow Restriction Training

Interventions

Blood Flow Restriction Training DEVICE

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

Standard Physical Therapy with BFRT

Sham Blood Flow Restriction Training DEVICE

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

Standard Physical Therapy with Sham BFRT

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Caitlin Conley: lead
• The Cleveland Clinic: collaborator

Study Sites (4)

UK Healthcare at Turfland

Lexington, Kentucky, 40504, United States

RECRUITING

University of Kentucky Biomotion Laboratory

Lexington, Kentucky, 40536, United States

RECRUITING

Center for Sports Performance and Research

Foxborough, Massachusetts, 02035, United States

RECRUITING

Foxboro Sports Medicine Clinic

Foxborough, Massachusetts, 02035, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35090543 DERIVED

MeSH Terms

Conditions

Patellar Dislocation; Knee Injuries; Leg Injuries; Wounds and Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Caitlin Conley, PhD

  University of Kentucky

  STUDY DIRECTOR

Central Study Contacts

Caitlin Conley, PhD

CONTACT

8592571939; caitlin.conley2@uky.edu

Natalie Corey

CONTACT

natalie.corey@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 18, 2020
• Study Start: September 9, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)