University of Colorado Denver
Aurora, Colorado, 80045, United States
NCT Number: NCT03325062
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.
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Notify Me50 year–85 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
for MRI
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.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
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
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
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
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
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
Assesses daily physical activity levels and number of steps.
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
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
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
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
Assesses the mobility of the knee joint.
Time frame: 10 weeks after surgery
Assesses the adherence of subjects as measured by home exercise program logs and number of clinical sessions attended.
Time frame: 10 weeks after surgery
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 and 2 years after surgery
Whole-organ MRI scoring method (WORMS) is a semi-quantitative, MRI-based scoring system that evaluates the integrity of articular cartilage, ligaments/tendons, menisci, bone marrow lesions, effusion, subchondral cysts, loose bodies, and popliteal cysts. The Total sum score ranges from 0-129 and is computed by summing the following subscales: Cartilage (0-36), Ligaments/tendons (0-24), Meniscus (0-24), Bone marrow Lesions (0-18), Joint Effusion (0-3), Subchondral Cysts (0-18), Loose Bodies (0-3), and Popliteal Cyst (0-3). Higher scores indicate greater amounts of joint degeneration.
Time frame: 2 years after surgery
Number of participants who have a contralateral TKA
University of Colorado, Denver
Other
Acronym: MOVE
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