Arthropathy of Knee JointRELOADNCT01333189
Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback
A study testing Weight-bearing biofeedback exercise in people with Arthropathy of Knee Joint, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- Weight-bearing biofeedback exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral total knee arthroplasty, body mass index <40 kg/m^2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Arthropathy of Knee Joint
- Being tested
- Weight-bearing biofeedback exercise, Standard of care exercise
- Keywords
- total knee arthroplasty, osteoarthritis, biomechanics, gait
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-bearing biofeedback exerciseOther
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.
Standard of care exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RELOAD: Weight-bearing biofeedback exercise | Experimental | 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. Receives: Other: Weight-bearing biofeedback exercise |
| CONTROL: Standard of care exercise | Active comparator | 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. Receives: Other: Standard of care exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)
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).
Measured: 6 weeks post-operative
Secondary outcomes (11)
Weight-bearing Ratio During Walking
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).
Measured: 6 weeks post-operative
Five Times Sit-to-Stand Test (FTSST)
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.
Measured: 6 weeks post-operative
Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test
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.
Measured: 6 weeks post-operative
Walking Speed
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.
Measured: 6 weeks post-operative
Hip, Knee, and Ankle Joint Moments During Walking
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.
Measured: 6 weeks post-operative
Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)
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).
Measured: 26 weeks post-operative
Weight-bearing Ratio During Walking
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).
Measured: 26 weeks post-operative
Five Times Sit-to-Stand Test (FTSST)
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.
Measured: 26 weeks post-operative
Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test
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.
Measured: 26 weeks post-operative
Walking Speed
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.
Measured: 26 weeks post-operative
Hip, Knee, and Ankle Moments During Walking
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.
Measured: 26 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of Knee JointStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Sponsor
- Investigators
- Cory L Christiansen, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333189
- Sponsor's protocol ID
- 10-1185
- Other IDs
- 2558404, K23AG029978, R01HD065900, T32AG000279
- Acronym
- RELOAD
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2011
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16140191Boonstra 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.
PubMed 20007664Christiansen 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.
PubMed 21839986Yoshida 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.
PubMed 23090437Christiansen 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.
PubMed 26207975
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Function After Knee Arthroplasty With Weight-Bearing Biofeedback
- ClinicalTrials.gov ID
- NCT01333189
- Acronym / sponsor ID
- RELOAD / 10-1185
- Conditions
- Arthropathy of Knee Joint
- Keywords
- total knee arthroplasty, osteoarthritis, biomechanics, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- 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)
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RELOAD: Weight-bearing biofeedback exercise | Experimental | Other: Weight-bearing biofeedback exerciseRELOAD 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. |
| CONTROL: Standard of care exercise | Active comparator | Other: Standard of care exerciseCONTROL 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral total knee arthroplasty, body mass index <40 kg/m^2
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight-bearing biofeedback exercisePatients 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. | Other | RELOAD: Weight-bearing biofeedback exercise |
| Standard of care exerciseStandard 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. | Other | CONTROL: Standard of care exercise |
Primary outcome
Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)
Time frame: 6 weeks post-operative
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).
11 secondary outcomes
Weight-bearing Ratio During Walking
Time frame: 6 weeks post-operative
Five Times Sit-to-Stand Test (FTSST)
Time frame: 6 weeks post-operative
Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test
Time frame: 6 weeks post-operative
Walking Speed
Time frame: 6 weeks post-operative
Hip, Knee, and Ankle Joint Moments During Walking
Time frame: 6 weeks post-operative
Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)
Time frame: 26 weeks post-operative
Weight-bearing Ratio During Walking
Time frame: 26 weeks post-operative
Five Times Sit-to-Stand Test (FTSST)
Time frame: 26 weeks post-operative
Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test
Time frame: 26 weeks post-operative
Walking Speed
Time frame: 26 weeks post-operative
Hip, Knee, and Ankle Moments During Walking
Time frame: 26 weeks post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16140191Mizner 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.
- Background: PubMed 20007664Boonstra 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.
- Background: PubMed 21839986Christiansen 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.
- Background: PubMed 23090437Yoshida 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.
- Derived from this study: PubMed 26207975Christiansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cory L Christiansen, PT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-bearing biofeedback exercise in people with Arthropathy of Knee Joint, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) (time frame: 6 weeks post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333189, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.