This research study explores the effects of movement pattern training using real-time biofeedback insoles after total knee arthroplasty. The purpose of this research study is to determine if the addition of a novel movement pattern training program (MOVE) to contemporary progressive rehabilitation leads to improved movement quality and physical function compared to contemporary progressive rehabilitation (CONTROL) alone.
Currently in the United States, more than 700,000 total knee arthroplasty (TKA) surgeries are performed annually, with projections of 3.5 million performed annually by 2030. The increasing incidence of TKA comes with an immediate need for establishing optimal rehabilitation guidelines to remediate common post-TKA physical impairments and improve functional outcomes. Over the past decade, a primary focus of the investigators' TKA rehabilitation research has been on progressive strengthening, which improves muscle strength and physical function, and is now the contemporary approach to TKA rehabilitation. However, a major issue remaining for patients rehabilitating from unilateral TKA is the persistence of atypical movement patterns. These atypical movement patterns, observed during walking and other functional tasks, are characterized by disuse of the surgical limb, resulting in smaller knee extension moments on the surgical limb compared to the non-surgical limb. As a result, atypical movement patterns following unilateral TKA are associated with persistent quadriceps weakness and poor physical function. The investigators will conduct a randomized controlled trial of 150 participants undergoing unilateral TKA to determine if the addition of a novel movement pattern training program (MOVE) to contemporary, progressive rehabilitation improves movement pattern quality more than contemporary progressive rehabilitation alone (CONTROL). The secondary goal is to determine if movement pattern training improves long-term physical function. Testing will occur pre-operatively and after TKA at 10 weeks (end of intervention), 6 months (primary endpoint), and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
The contemporary progressive rehabilitation program consists of progressive resistive exercise to key lower extremity muscle groups, knee range of motion exercise, weight-bearing exercise, as well as education on symptom management strategies.
The MOVE program emphasizes movement pattern retraining in conjunction with contemporary rehabilitation. More specifically, the MOVE program promotes symmetry in functional knee motion and loading without postural compensation. Intervention uses pressure-sensing shoe insoles to deliver real-time visual biofeedback during activity performance.
University of Colorado Denver
Aurora, Colorado, United States
Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed
Peak Knee Extension Moment (PKEM) during walking at a fixed speed of 1.0 m/s
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in PKEM during activities
PKEM during walking at self-selected gait speed, rising and lowering from a chair, and stepping up and down a step
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Six-minute Walk (6MW) Test
Developed and used extensively to measure endurance, measures the distance walked in six minutes.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Stair Climbing Test (SCT)
Measures a higher level of function that minimizes the possibility of a ceiling effect
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in 30-Second Sit-to-Stand Test (30-STS)
Assesses lower body strength and the fatigue effect caused by the number of sit-to-stand repetitions.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Accelerometer-based Physical Activity
Assesses daily physical activity levels and number of steps.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Quadriceps Strength
Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle
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Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Assesses self-reported physical function. Scale assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis. Total score range is 0-96. Total score is computed by summing three subscales: pain (range 0-20), stiffness (range 0-8), and functional limitations (range 0-68), then dividing by total points possible. Higher scores indicate worse pain, stiffness, and functional limitations.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Veterans RAND 12 item health survey (VR-12)
A generic instrument to measure health related quality of life. The VR-12 has two subscales, the Physical Component Score (PCS) and the Mental Component Score (MCS). The PCS and MCS summary scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Timed Up and Go (TUG)
The TUG evaluates mobility through the time required to rise from an arm chair, walk 3 meters, turn and walk back to the arm chair, and return to a seated position.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in knee range of motion (ROM)
Assesses the mobility of the knee joint.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Adherence to the intervention
Assesses the adherence of subjects as measured by home exercise program logs and number of clinical sessions attended.
Time frame: 10 weeks after surgery
Satisfaction with rehabilitation program
Assesses the satisfaction of subjects with their assigned rehabilitation program using a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied".
Time frame: 10 weeks after surgery