Clinical trial NCT01333189: Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback
Official title: Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy of Knee Joint
Keywords: total knee arthroplasty
osteoarthritis
biomechanics
gait
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-04-11
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if rehabilitation using weight-bearing biofeedback training following total knee arthroplasty (TKA) is more effective than standard rehabilitation methods in promoting weight-bearing symmetry through the lower limbs during functional activities such as sit-to-stand transfers and walking. Secondary outcomes of interest include functional measures and internal moment at the hip, knee, and ankle joints during sit-to-stand and walking.

Detailed description: People who have had knee replacement surgery typically have worse physical function compared to healthy people of similar age. This problem occurs despite completion of standard rehabilitation programs. One reason for less-than-optimal restoration of physical function is that standard rehabilitation does not effectively address habitual movement patterns that persist after surgery. These movement patterns are characterized by patients placing less weight on their surgical leg compared to their non-surgical leg after surgery. This asymmetrical movement pattern has been identified by researchers and shown to not completely resolve after knee replacement surgery, even though the surgery reliably reduces knee pain. The persistence of asymmetrical weight-bearing during every day activity may limit the stimulus needed for full recovery by the muscles and joints of the surgical leg. By promoting increased loading of the surgical leg, a greater stimulus can be provided to promote better functional recovery, compared with standard rehabilitation. As a result, people may subsequently move more symmetrically with improved recovery of physical function. Improved function would in turn promote the person's ability to participate in life events, limiting disability. Considering that over 500,000 knee replacement surgeries occur in the United States each year, maximizing functional recovery and limiting disability following surgery are important goals.

The investigators propose a new method of exercising following knee replacement surgery. This method involves using a commercially available game system to promote "re-loading" of the surgical limb. The game system has games designed to allow the person playing to move objects or characters on a screen by shifting his/her weight from one leg to another while standing on an instrumented "balance board". The investigators have developed an exercise program to promote shifting weight to the surgical limb, by choosing appropriate games and manipulating the goals of those games. It is the investigators' hypothesis that early application of this surgical leg "re-loading" intervention after knee replacement will result in meaningful improvement in physical function by improving movement symmetry.

Eligibility criteria: Inclusion Criteria:

* unilateral total knee arthroplasty, body mass index \<40 kg/m\^2

Exclusion Criteria:

* neurological, vascular or cardiac problems that limited physical function, contralateral knee pain greater than 2/10 on a numerical pain rating scale, severe osteoarthritis or other orthopaedic conditions in the non-operated lower extremity that limited function, sub-acute inpatient rehabilitation following unilateral total knee arthroplasty, uncontrolled diabetes, smoking or drug abuse, living \>45 minutes away from the outpatient rehabilitation clinic, surgical complication requiring an altered course of rehabilitation, inability to walk 30 meters without an assistive device or inability to rise from a chair without use of arms

Primary outcomes:
measure: Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)
timeFrame: 6 weeks post-operative
Secondary outcomes:
measure: Weight-bearing Ratio During Walking
timeFrame: 6 weeks post-operative
measure: Five Times Sit-to-Stand Test (FTSST)
timeFrame: 6 weeks post-operative
measure: Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test
timeFrame: 6 weeks post-operative
measure: Walking Speed
timeFrame: 6 weeks post-operative
measure: Hip, Knee, and Ankle Joint Moments During Walking
timeFrame: 6 weeks post-operative
measure: Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)
timeFrame: 26 weeks post-operative
measure: Weight-bearing Ratio During Walking
timeFrame: 26 weeks post-operative
measure: Five Times Sit-to-Stand Test (FTSST)
timeFrame: 26 weeks post-operative
measure: Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test
timeFrame: 26 weeks post-operative
measure: Walking Speed
timeFrame: 26 weeks post-operative
measure: Hip, Knee, and Ankle Moments During Walking
timeFrame: 26 weeks post-operative
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cory L Christiansen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mizner RL, Snyder-Mackler L. Altered loading during walking and sit-to-stand is affected by quadriceps weakness after total knee arthroplasty. J Orthop Res. 2005 Sep;23(5):1083-90. doi: 10.1016/j.orthres.2005.01.021. Epub 2005 Mar 28.
citation: Boonstra MC, Schwering PJ, De Waal Malefijt MC, Verdonschot N. Sit-to-stand movement as a performance-based measure for patients with total knee arthroplasty. Phys Ther. 2010 Feb;90(2):149-56. doi: 10.2522/ptj.20090119. Epub 2009 Dec 10.
citation: Christiansen CL, Bade MJ, Judd DL, Stevens-Lapsley JE. Weight-bearing asymmetry during sit-stand transitions related to impairment and functional mobility after total knee arthroplasty. Arch Phys Med Rehabil. 2011 Oct;92(10):1624-9. doi: 10.1016/j.apmr.2011.05.010. Epub 2011 Aug 12.
citation: Yoshida Y, Zeni J, Snyder-Mackler L. Do patients achieve normal gait patterns 3 years after total knee arthroplasty? J Orthop Sports Phys Ther. 2012 Dec;42(12):1039-49. doi: 10.2519/jospt.2012.3763. Epub 2012 Oct 22.
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.