Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback (RELOAD)
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Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthropathy of Knee Joint |
Other: Weight-bearing biofeedback exercise Other: Standard of care exercise |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback |
- Weight-bearing symmetry [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]Weight-bearing symmetry is measured during transitions between sitting and standing and compared to the control group as indicated by greater symmetry in vertical ground reaction force (vGRF) between lower limbs.
- Five Times Sit-to-Stand Test [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]The Five Times Sit-to-Stand Test will be quantified as the total time required for an individual to rise from and return to a chair five times in a row.
- Six-minute Walk Test [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]The Six-minute Walk Test will assess gait function on level surfaces and is a standardized measure of the total distance walked over 6 minutes.
- Stair Climb Test [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]The Stair Climb Test will be used to assess gait function on stairs and is a standardized measure of the time to ascend and descend a flight of stairs.
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Weight-bearing Biofeedback |
Other: Weight-bearing biofeedback exercise
Patients in the experimental group will complete the same standard of care rehabilitation program as the control group. Thus, the experimental intervention will be in addition to the standard intervention. Upon discharge to home, patients in the RELOAD group will begin the WB biofeedback phase of the study. Patients will participate in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. |
| Active Comparator: Standard of Care |
Other: Standard of care exercise
Standard inpatient rehabilitation will begin on post-operative day 1 and last for an estimated 3 days. After hospital discharge, two weeks of home rehabilitation (6 visits) will be provided by physical therapists. Patients will progress to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge will be implemented for both groups.
|
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- unilateral total knee arthroplasty, body mass index <35 kg/m2
Exclusion Criteria:
- neurological, vascular or cardiac problems that limit physical function, severe osteoarthritis or other orthopaedic conditions in the non-operated lower extremity that limit function, sub-acute inpatient rehabilitation following unilateral total knee arthroplasty
Contacts and Locations| Contact: Cory L Christiansen, PT, PhD | 303 724-9101 |
| United States, Colorado | |
| University of Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Cory L Christiansen, PT, PhD 303-724-9101 | |
| Principal Investigator: Cory L Christiansen, PT, PhD | |
| Sub-Investigator: Jennifer L Stevens-Lapsley, PT, PhD | |
| Principal Investigator: | Cory L Christiansen, PT, PhD | University of Colorado, Denver |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01333189 History of Changes |
| Other Study ID Numbers: | 10-1155, 2558404 |
| Study First Received: | April 8, 2011 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
TKA OA biomechanics gait |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013