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Completed

NCT Number: NCT03325062

Movement Pattern Biofeedback Training After Total Knee Arthroplasty

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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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Behavioral

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.

Experimental: MOVE

Behavioral

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.

Primary outcomes

  1. Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed

    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

Secondary outcomes

  1. Change in PKEM during activities

    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

  2. Change in Six-minute Walk (6MW) Test

    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.

  3. Change in Stair Climbing Test (SCT)

    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

  4. Change in 30-Second Sit-to-Stand Test (30-STS)

    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.

  5. Change in Accelerometer-based Physical Activity

    Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery

    Assesses daily physical activity levels and number of steps.

  6. Change in Quadriceps Strength

    Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery

    Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle

  7. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    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.

  8. Change in Veterans RAND 12 item health survey (VR-12)

    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.

  9. Change in Timed Up and Go (TUG)

    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.

  10. Change in knee range of motion (ROM)

    Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery

    Assesses the mobility of the knee joint.

  11. Adherence to the intervention

    Time frame: 10 weeks after surgery

    Assesses the adherence of subjects as measured by home exercise program logs and number of clinical sessions attended.

  12. Satisfaction with rehabilitation program

    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".

Other outcomes

  1. Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score

    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.

  2. Incidence of contralateral TKA

    Time frame: 2 years after surgery

    Number of participants who have a contralateral TKA

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of California, San Francisco
  • University of Delaware

Registry information

Acronym: MOVE

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2017
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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