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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
With 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 consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGChange in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Time frame: at start of PT, 1 month after start of PT
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Time frame: at start of PT, 2 months after start of PT
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Time frame: at start of PT, 5 months after start of PT
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Time frame: at start of PT, 1 month after start of PT
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Time frame: at start of PT, 2 months after start of PT
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Time frame: at start of PT, 5 months after start of PT
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.
Time frame: at start of PT, 1 month after start of PT
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.
Time frame: at start of PT, 2 months after start of PT
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.
Time frame: at start of PT, 5 months after start of PT
Isometric quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Time frame: 1 month after start of PT
Isometric quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Isokinetic quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 1 month after start of PT
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 2 months after start of PT
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 5 months after start of PT
Functional Performance as Assessed by Balance Error Scoring System
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Functional Performance as Assessed by Balance Error Scoring System
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Initiation of PT is 1 month after surgery.
Time frame: 2 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Initiation of PT is 1 month after surgery.
Time frame: 5 months after start of PT
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 1 month after start of PT
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 2 months after start of PT
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 5 months after start of PT
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 1 month after start of PT
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 2 months after start of PT
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 5 months after start of PT
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 1 month after start of PT
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 2 months after start of PT
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 5 months after start of PT
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 1 month after start of PT
Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 2 months after start of PT
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 5 months after start of PT
Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 1 month after start of PT
Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 2 months after start of PT
Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale
Initiation of PT is 1 month after surgery.
Time frame: at start of PT, 5 months after start of PT
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