CompletedNot Applicable

BFRT MPFL and ACL Reconstruction Rehab

United States43 participantsStarted 2021-06-29

Plain-language summary

Blood flow restrictive (BFR) therapy following MPFL or ACL reconstruction rehabilitation. Specific Aim 1: Test whether maintaining BFR cuff inflation or deflating between exercises results in greater quadriceps strength and functional outcomes after MPFL or ACL reconstruction. Hypothesis 1: Subjects in the deflate BFR protocol group will have significantly greater quadriceps strength, symmetric leg symmetry index on a battery of functional tests and PROs as compared to the non-deflate group. Specific Aim 2: Compare whether maintaining BFR cuff inflation or deflating between exercises results in reduced pain, improved exercise tolerance, and patient-reports outcomes (PRO) after MPFL or ACL reconstruction. Hypothesis 2: Subjects in the deflated BFR protocol group will report significantly less pain and greater exercise tolerance during exercise with significantly improved knee related PRO scores.

Who can participate

Age range13 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Post operative Medial Patellar Femoral Ligament or Anterior Cruciate Ligament Reconstruction. Exclusion Criteria: * Had any other previous surgeries or conditions that might affect your gait prior to injury and 1 year removed from a prior ACL or MPFL reconstruction. * Have any current lower extremity condition other than MPFL or ACL reconstruction which might affect your gait * Have a diminished capacity to provide informed consent * Are diabetic or have uncontrolled hypertension * Have recent inflammation, bleeding disorders, active bleeding or infection within the lower limbs. * You are taking warfarin/Coumadin, clopidogrel/Plavix, Rivaroxaban/Xarelto, Dabigatran/Pradaxa, apixaban/Eliquis, deoxidant/Savaysa, betrixaban, or any other anti-coagulants that may cause excess bleeding. * Have any implanted medical device * Have a history of deep vein thrombosis, vascular graft, varicose veins, and/or sickle cell anemia * Are or suspect you are Pregnant * You are not be able to attend regular physical therapy or study visits

What they're measuring

Quadriceps Isometric Knee Strength

Timeframe: 24th visit or 12 weeks Post-op (if missed appointments)

Hip abduction Isometric Strength

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Y Balance Anterior Reach Test

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Maximum 6 inch forward step down test

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Max core strength assessment

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Ability to in-line jog

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Lower Extremity Functional Scale (LEFS)

Timeframe: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)

Trial details

NCT IDNCT05426954

SponsorRichard Watson, PT

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-28

View on ClinicalTrials.gov More Medial Patellar Femoral Ligament Reconstruction Rehabilitation trials

Plain-language summary

Who can participate

Age range13 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Quadriceps Isometric Knee Strength

Timeframe: 24th visit or 12 weeks Post-op (if missed appointments)

Hip abduction Isometric Strength

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Y Balance Anterior Reach Test

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Maximum 6 inch forward step down test

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Max core strength assessment

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Ability to in-line jog

Timeframe: measured at the 24th visit or 12 weeks Post-op (if missed appointments)

Lower Extremity Functional Scale (LEFS)

Timeframe: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)