The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post-operative rehabilitation following knee arthroscopy for primary ACL reconstruction. BFR has been shown to effect time to return to activity and strength postoperatively. This study aims to analyze the effects of BFR therapy in patients who underwent primary ACL reconstruction surgery compared to controls. Participants will be randomized into either a treatment (BFR Cuff) or control (no BFR cuff) group. All participants will follow standard of care (SOC) physical therapy protocol for 12 weeks after surgery according to their treatment group. Strength and patient outcome measures will be recorded throughout the 2 year study period.
The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following knee arthroscopy. The current standard of care and post-operative pain levels can limit patients from applying load necessary to increase muscle size and strength development due to partial weight baring after surgery. We hypothesize that immediate and consistent use of BFR augmenting our current standard post operative knee arthroscopy rehabilitation protocol will result in greater improvement in strength and quicker achievement of phase-based rehabilitation goals. We hypothesize that these objective improvements in strength will correlate with clinically meaningful improvement in Tegner activity scale, International Knee Documentation Committee (IKDC), return to sport, Lower Extremity Functional Scale (LEFS), pain and resiliency (patient reported outcome, PRO) scores indicative of greater functional recovery compared to our standard rehabilitation protocol alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
The BFR cuff will be applied to the proximal thigh of the surgical leg while the patient completes specified physical therapy exercises.80% occlusion pressure will be determined by PT's in clinic through the use of a Delphi unit. Subjects will then be able to use the Saga Fitness app to adjust this pressure if it differs from the automatic calibrated pressure.
UCHealth Steadman Hawkins Clinic
Centennial, Colorado, United States
Knee extensor strength
Strength of knee extensors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative lim
Time frame: 6 months
hamstrings musculature strength
Strength of knee flexors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb.
Time frame: 6 months
single leg squat test
Performance on a Repeated Single Leg Squat test to 45 deg knee flexion over the course of 90 seconds reported as a measure of LSI
Time frame: 6 months
Tegner Activity Scale
Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)
Time frame: 6 months
LEFS
Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123
Time frame: 2 years
Pain NPRS
Range 1 (low pain) -10 (high pain); MDC = Δ 34
Time frame: 2 Years
PROMIS Pain
Range 0 (low pain) -100 (highpain); MDC = Δ 85
Time frame: 2 Years
PROMIS Physical Function
Range 0 (low function) -100 (high function); MDC = Δ 85
Time frame: 2 Years
Brief Resiliency Score (BRS)
Range 1(low resilience) -5 (high resilience); MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)
Time frame: 2 Years
ACL-RSI
Range 1 (low function) -100 (high function); MDC = ∆15.1 for short form version
Time frame: 2 Years
IKDC
Range 1 (low function) -100 (high function); MDC = ∆8.8 low to ∆15.6 high
Time frame: 2 Years
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