BFRT MPFL and ACL Reconstruction Rehab

Blood Flow Restrictive Training Following Medial Patellar Femoral Ligament and Anterior Cruciate Ligament Reconstruction Rehabilitation

Sponsors

Lead Sponsor: Richard Watson, PT

Source University of Kentucky
Brief 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.

Detailed Description

Subjects will be aged 13-40 male or female patient following MPFL or ACL reconstruction. Baseline Assessment at PT Evaluation will included knee AROM and AAROM Heel slide with strap, Knee edema measured in cm difference Involved to Non-involved at supra and mid patellar levels, subjects ability to SLR Yes/No in brace, Patient reported outcome measure (PRO's) to include LEFS, Brief Resiliency scale, MPFL - Norwich Patellar instability, ACL 2000 IKDC Subjective Knee Evaluation Form questionnaires. Pain assessment to include current, minimal and maximal pain levels past 24 hours. Patient are randomized into 1 of 2 groups: Group 1 will deflate between BFR exercises, Group 2 will not deflate between BFR exercises. Both groups will receive the same standard care same during their first 2 weeks of post-op rehabilitation. BFR will be added to their rehabilitation care starting at week 3 for 2x/week x 10. There are 4 core BFR exercises that will be progressed every 2 weeks. Final Assessment- Strength and Functional Testing at 24th visit or 12 weeks post-op (if missed appointments) to include bilateral Knee AROM and edema assessments, PRO's: LEFS, Brief Resiliency scale, MPFL Norwich Patellar instability, ACL 2000 IKDC Subjective Knee Evaluation Form, Functional assessment to include for involved adn uninvolved leg: Isometric Quad strength measurement at 90 degrees of knee flexion, Isometric Hip Abduction strength measurement, Y balance maximum anterior reach, Max reps 6" Forward step-down, max core strength assessments, and ability in-line jog.

Overall Status Recruiting
Start Date 2021-06-29
Completion Date 2023-10-31
Primary Completion Date 2023-05-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Quadriceps Isometric Knee Strength 24th visit or 12 weeks Post-op (if missed appointments)
Hip abduction Isometric Strength measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Y Balance Anterior Reach Test measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Maximum 6 inch forward step down test measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Max core strength assessment measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Ability to in-line jog measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Lower Extremity Functional Scale (LEFS) measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
Brief Resiliency Scale measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
Norwich Patellar Instability measured at PT Evaluation and 24th visit or 12 weeks Post-op (if mised appointments)
2000 IKDC Subjective Knee Evaluation Form measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
Secondary Outcome
Measure Time Frame
Discomfort level Measured at each treatment follwoing each BFR exercise - Specific Aim 2
Effort Level Measured at each treatment follwoing each BFR exercise - Specific Aim 2
Enrollment 32
Condition
Intervention

Intervention Type: Other

Intervention Name: Rehabilitation utilizing blood flow restrictive therapy

Description: BFR therapy

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

13 Years

Maximum Age:

40 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Richard Watson, PT

Phone: 859-257-4576

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: University of Kentucky Sports Rehabilitation Richard Watson, PT 859-257-4576 [email protected]
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Kentucky

Investigator Full Name: Richard Watson, PT

Investigator Title: Co-Invetigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: BFR deflate

Type: Active Comparator

Description: BFR cuff will be deflated at the end of each of the 4 BFR exercises, BFR cuff is inflated prior to start next BFR exercise.

Label: BFR do not deflate

Type: Active Comparator

Description: BFR cuff will not be deflated at the end of each of the 4 BFR exercises. Cuff remains inflated start exercise 1 thru completion exercise 4.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized Rehabilitation

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News