Trial record 1 of 1 for:    Improving function after knee arthroplasty with weight-bearing biofeedback
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Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback (RELOAD)

This study has been completed.
Sponsor:
Collaborators:
Foundation for Physical Therapy, Inc.
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01333189
First received: April 8, 2011
Last updated: August 7, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention
Arthropathy of Knee Joint
Other: Weight-bearing biofeedback exercise
Other: Standard of care exercise

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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
    Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).


Secondary Outcome Measures:
  • Weight-bearing Ratio During Walking [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
    Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).

  • Five Times Sit-to-Stand Test (FTSST) [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
    The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.

  • Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
    Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.

  • Walking Speed [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
    Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.

  • Hip, Knee, and Ankle Joint Moments During Walking [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
    Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.

  • Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) [ Time Frame: 26 weeks post-operative ] [ Designated as safety issue: Yes ]
    Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).

  • Weight-bearing Ratio During Walking [ Time Frame: 26 weeks post-operative ] [ Designated as safety issue: No ]
    Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).

  • Five Times Sit-to-Stand Test (FTSST) [ Time Frame: 26 weeks post-operative ] [ Designated as safety issue: No ]
    The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.

  • Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test [ Time Frame: 26 weeks post-operative ] [ Designated as safety issue: No ]
    Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.

  • Walking Speed [ Time Frame: 26 weeks post-operative ] [ Designated as safety issue: No ]
    Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.

  • Hip, Knee, and Ankle Moments During Walking [ Time Frame: 26 weeks post-operative ] [ Designated as safety issue: No ]
    Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.


Enrollment: 26
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RELOAD: Weight-bearing biofeedback exercise
RELOAD participants participated 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. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.
Other: Weight-bearing biofeedback exercise

Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.

Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated 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: CONTROL: Standard of care exercise
CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation. Total dose of exercise across groups was matched.
Other: Standard of care exercise
Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of 3.2 days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.

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

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333189

Locations
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Foundation for Physical Therapy, Inc.
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Cory L Christiansen, PT, PhD University of Colorado, Denver
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01333189     History of Changes
Other Study ID Numbers: 10-1185  2558404  K23AG029978  R01HD065900  T32AG000279 
Study First Received: April 8, 2011
Results First Received: August 7, 2015
Last Updated: August 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
total knee arthroplasty
osteoarthritis
biomechanics
gait

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 24, 2016