MOVE: Movement Pattern Biofeedback Training After Total Knee Arthroplasty
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: MOVE Movement pattern training in addition to contemporary progressive rehabilitation |
Behavioral: MOVE
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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| Active Comparator: CONTROL Contemporary progressive rehabilitation |
Behavioral: Control
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.
|
Outcome Measures
Primary Outcome Measures
- Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed [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 Outcome Measures
- Change in PKEM during activities [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
- Change in Six-minute Walk (6MW) Test [Baseline, 10 weeks, 6 months, and 2 years after surgery]
Developed and used extensively to measure endurance, measures the distance walked in six minutes.
- Change in Stair Climbing Test (SCT) [Baseline, 10 weeks, 6 months, and 2 years after surgery]
Measures a higher level of function that minimizes the possibility of a ceiling effect
- Change in 30-Second Sit-to-Stand Test (30-STS) [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.
- Change in Accelerometer-based Physical Activity [Baseline, 10 weeks, 6 months, and 2 years after surgery]
Assesses daily physical activity levels and number of steps.
- Change in Quadriceps Strength [Baseline, 10 weeks, 6 months, and 2 years after surgery]
Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [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.
- Change in Veterans RAND 12 item health survey (VR-12) [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.
- Change in Timed Up and Go (TUG) [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.
- Change in knee range of motion (ROM) [Baseline, 10 weeks, 6 months, and 2 years after surgery]
Assesses the mobility of the knee joint.
- Adherence to the intervention [10 weeks after surgery]
Assesses the adherence of subjects as measured by home exercise program logs and number of clinical sessions attended.
- Satisfaction with rehabilitation program [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 Outcome Measures
- Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score [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.
- Incidence of contralateral TKA [2 years after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
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50-85 years old
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primary, unilateral knee arthroplasty for end-stage osteoarthritis
Exclusion Criteria:
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Moderate to severe contralateral knee OA (>4/10 on verbal pain rating (VPR) or KL grade >3)
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Current smoker
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Drug abuse
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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)
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Discharge to location other than home after surgery
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Unstable orthopedic conditions that limit function
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Uncontrolled diabetes (hemoglobin A1c level >8.0)
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Body mass index >40 kg/m2
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Surgical complication necessitating an altered course of rehabilitation
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Previous contralateral TKA
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Unable to safely walk 30m without an assistive device
Exclusion criteria for MRI
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Ferromagnetic metal implants or pacemakers
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Other contraindications to MRI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- National Institute on Aging (NIA)
- University of California, San Francisco
- University of Delaware
Investigators
- Principal Investigator: Jennifer E Stevens-Lapsley, PT, PhD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 17-1701
- R01AG056585