Movement Pattern Biofeedback Training After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Movement Pattern Biofeedback Training After Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty, Older Adults

Intervention / Treatment
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* Behavioral: MOVE
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-85 years old primary, unilateral knee arthroplasty for end-stage osteoarthritis Exclusion Criteria: Moderate to severe contralateral knee OA (>4/10 on verbal pain rating (VPR) or KL grade >3) Current smoker Drug abuse Comorbid conditions that substantially limit physical function or would interfere with the participant's ability to successfully complete rehabilitation (e.g. neurologic, vascular, cardiac problems, or ongoing medical treatments) Discharge to location other than home after surgery Unstable orthopedic conditions that limit function Uncontrolled diabetes (hemoglobin A1c level >8.0) Body mass index >40 kg/m2 Surgical complication necessitating an altered course of rehabilitation Previous contralateral TKA Unable to safely walk 30m without an assistive device Exclusion criteria for MRI Ferromagnetic metal implants or pacemakers Other contraindications to MRI

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: MOVE<br>Movement pattern training in addition to contemporary progressive rehabilitation | Behavioral: MOVE<br>* 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.<br>|
| Active Comparator: CONTROL<br>Contemporary progressive rehabilitation | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 10 weeks, 6 months, and 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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. | 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. | 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 | 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. | 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. | 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. | Baseline, 10 weeks, 6 months, and 2 years after surgery | 
| Change in knee range of motion (ROM) | Assesses the mobility of the knee joint. | 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. | 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. | 10 weeks after surgery |