About this trial
The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR training compared to PT alone (without BFR training) after ACL reconstruction in patients who require extended limited weight bearing through assessment of patient reported outcomes and functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of quadriceps muscle cross-sectional area, strength, and function while also improving early clinical and functional results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Anterior cruciate ligament (ACL) reconstruction with concomitant meniscus or cartilage restoration procedures
Adherence to modified weight bearing status before initiation of PT
Expected participation in recreational or competitive sports after release to full activities
Disqualifiers
Unable to attend (or participate in) physical therapy
Pregnancy
Malignancy
Fracture
Trial design
Parallel
Treatments tested in this trial
Blood flow restriction
DeviceWith BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg).
Physical therapy
Other interventionPhysical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion.
Treatment groups
Trial outcomes
Primary outcomes
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Secondary outcomes
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb. Initiation of PT is 1 month after surgery.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
Memorial Hermann Hospital
Collaborator