Clinical trial NCT03325062: Movement Pattern Biofeedback Training After Total Knee Arthroplasty
Official title: Movement Pattern Biofeedback Training After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Older Adults
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of Delaware
name: National Institute on Aging (NIA)
First posted: 2017-10-30
Enrollment: 138
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 50-85 years old
2. primary, unilateral knee arthroplasty for end-stage osteoarthritis

Exclusion Criteria:

1. Moderate to severe contralateral knee OA (\>4/10 on verbal pain rating (VPR) or KL grade \>3)
2. Current smoker
3. Drug abuse
4. 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)
5. Discharge to location other than home after surgery
6. Unstable orthopedic conditions that limit function
7. Uncontrolled diabetes (hemoglobin A1c level \>8.0)
8. Body mass index \>40 kg/m2
9. Surgical complication necessitating an altered course of rehabilitation
10. Previous contralateral TKA
11. Unable to safely walk 30m without an assistive device

Exclusion criteria for MRI

1. Ferromagnetic metal implants or pacemakers
2. Other contraindications to MRI

Primary outcomes:
measure: Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary outcomes:
measure: Change in PKEM during activities
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in Six-minute Walk (6MW) Test
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in Stair Climbing Test (SCT)
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in 30-Second Sit-to-Stand Test (30-STS)
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in Accelerometer-based Physical Activity
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in Quadriceps Strength
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in Veterans RAND 12 item health survey (VR-12)
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in Timed Up and Go (TUG)
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Change in knee range of motion (ROM)
timeFrame: Baseline, 10 weeks, 6 months, and 2 years after surgery
measure: Adherence to the intervention
timeFrame: 10 weeks after surgery
measure: Satisfaction with rehabilitation program
timeFrame: 10 weeks after surgery
Other outcomes:
measure: Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score
timeFrame: 10 weeks and 2 years after surgery
measure: Incidence of contralateral TKA
timeFrame: 2 years after surgery
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer E Stevens-Lapsley, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.