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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG056585 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of Delaware | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: MOVE | Experimental | Movement pattern training in addition to contemporary progressive rehabilitation |
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| CONTROL | Active Comparator | Contemporary progressive rehabilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score | 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. |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for MRI
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer E Stevens-Lapsley, PT, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26207975 | Background | Christiansen CL, Bade MJ, Davidson BS, Dayton MR, Stevens-Lapsley JE. Effects of Weight-Bearing Biofeedback Training on Functional Movement Patterns Following Total Knee Arthroplasty: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Sep;45(9):647-55. doi: 10.2519/jospt.2015.5593. Epub 2015 Jul 24. | |
| 23892267 | Background | Zeni J Jr, Abujaber S, Flowers P, Pozzi F, Snyder-Mackler L. Biofeedback to promote movement symmetry after total knee arthroplasty: a feasibility study. J Orthop Sports Phys Ther. 2013 Oct;43(10):715-26. doi: 10.2519/jospt.2013.4657. Epub 2013 Aug 30. |
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A de-identified, anonymized dataset will be shared in a publication, which will be available through pubmed within a year of publication.
Publications will be made available to the public through PubMed Central within one year after the date of publication.
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Participants are only informed that they will participate in one of two post-operative rehabilitation programs (without specific details). Outcome assessors are also blinded to group assignment.
| 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. |
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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 |
| 10 weeks and 2 years after surgery |
| Incidence of contralateral TKA | Number of participants who have a contralateral TKA | 2 years after surgery |
| 22333656 | Background | McClelland J, Zeni J, Haley RM, Snyder-Mackler L. Functional and biomechanical outcomes after using biofeedback for retraining symmetrical movement patterns after total knee arthroplasty: a case report. J Orthop Sports Phys Ther. 2012 Feb;42(2):135-44. doi: 10.2519/jospt.2012.3773. Epub 2012 Feb 1. |
| 40923522 | Derived | Capin JJ, Zeni JA Jr, Forster JE, Cheuy VA, Peters A, Hogan C, Yang C, Christiansen CL, Stevens-Lapsley JE, Bade MJ. Preoperative and Post-Rehabilitation Predictors of Gait Biomechanics Six Months After Total Knee Arthroplasty. J Orthop Res. 2025 Nov;43(11):1964-1972. doi: 10.1002/jor.70052. Epub 2025 Sep 9. |