Arthropathy of Knee Joint
Conditions
Keywords
total knee arthroplasty, osteoarthritis, biomechanics, gait
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.
Interventions
OTHERWeight-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.
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.
Sponsors
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)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Five Times Sit-to-Stand Test (FTSST) | 6 weeks post-operative | 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 | 6 weeks post-operative | 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 | 6 weeks post-operative | 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. |
| Weight-bearing Ratio During Walking | 6 weeks post-operative | 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). |
| Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) | 26 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). |
| Hip, Knee, and Ankle Moments During Walking | 26 weeks post-operative | 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. |
| Hip, Knee, and Ankle Joint Moments During Walking | 6 weeks post-operative | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 13 |
| 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.
Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of \[3\] 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. | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Moved from region | 0 | 1 |
| Overall Study | Time constraints | 1 | 0 |
| Overall Study | Transportation difficulties | 0 | 1 |
Baseline characteristics
| Characteristic | RELOAD: Weight-bearing Biofeedback Exercise | CONTROL: Standard of Care Exercise | Total |
|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 8.6 | 66.6 years STANDARD_DEVIATION 8.1 | 67.4 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 1 / 13 | 0 / 13 |
Outcome results
Primary
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).
Time frame: 6 weeks post-operative
Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) | 0.77 ratio | Standard Deviation 0.1 |
| CONTROL: Standard of Care Exercise | Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) | 0.8 ratio | Standard Deviation 0.11 |
p-value: =0.329Mixed Models Analysis
Secondary
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.
Time frame: 26 weeks post-operative
Population: At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Five Times Sit-to-Stand Test (FTSST) | 9.5 seconds | Standard Deviation 2.4 |
| CONTROL: Standard of Care Exercise | Five Times Sit-to-Stand Test (FTSST) | 9.6 seconds | Standard Deviation 1.6 |
p-value: =0.021Mixed Models Analysis
Secondary
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.
Time frame: 6 weeks post-operative
Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Five Times Sit-to-Stand Test (FTSST) | 11.5 seconds | Standard Deviation 1.6 |
| CONTROL: Standard of Care Exercise | Five Times Sit-to-Stand Test (FTSST) | 12.7 seconds | Standard Deviation 3.3 |
p-value: =0.021Mixed Models Analysis
Secondary
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.
Time frame: 6 weeks post-operative
Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Hip Moment | 0.73 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.28 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Knee Moment | 0.77 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.21 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Ankle Moment | 0.29 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.14 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Hip Moment | 0.80 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.26 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Knee Moment | 0.72 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.18 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Ankle Moment | 0.31 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.17 |
Comparison: Internal moment at the hipp-value: =0.509Mixed Models Analysis
Comparison: Internal moment at the kneep-value: =0.5Mixed Models Analysis
Comparison: Internal moment at the anklep-value: =0.607Mixed Models Analysis
Secondary
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.
Time frame: 26 weeks post-operative
Population: At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Hip Moment | 0.65 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.24 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Knee Moment | 1.03 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.22 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Ankle Moment | 0.17 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.16 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Hip Moment | 0.63 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.2 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Knee Moment | 0.97 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.11 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test | Ankle Moment | 0.24 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.14 |
Comparison: Internal moment at the hipp-value: =0.686Mixed Models Analysis
Comparison: Internal moment at the kneep-value: =0.434Mixed Models Analysis
Comparison: Internal moment at the anklep-value: =0.227Mixed Models Analysis
Secondary
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.
Time frame: 6 weeks post-operative
Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Walking | Hip Moment | 0.28 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.26 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Walking | Knee Moment | 0.47 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.22 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Joint Moments During Walking | Ankle Moment | 0.17 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.23 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Walking | Hip Moment | 0.26 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.21 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Walking | Knee Moment | 0.46 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.37 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Joint Moments During Walking | Ankle Moment | 0.17 Newton-meters per kilogram (Nm/kg) | Standard Deviation 0.32 |
Comparison: Internal moment at the hipp-value: =0.48Mixed Models Analysis
Comparison: Internal moment at the kneep-value: =0.12Mixed Models Analysis
Comparison: Internal moment at the anklep-value: =0.668Mixed Models Analysis
Secondary
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.
Time frame: 26 weeks post-operative
Population: At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Moments During Walking | Hip Moment | 0.28 Newton-meters per kilogram (Nm/kg) | Standard Error 0.19 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Moments During Walking | Knee Moment | 0.61 Newton-meters per kilogram (Nm/kg) | Standard Error 0.25 |
| RELOAD: Weight-bearing Biofeedback Exercise | Hip, Knee, and Ankle Moments During Walking | Ankle Moment | 0.09 Newton-meters per kilogram (Nm/kg) | Standard Error 0.29 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Moments During Walking | Hip Moment | 0.36 Newton-meters per kilogram (Nm/kg) | Standard Error 0.22 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Moments During Walking | Knee Moment | 0.42 Newton-meters per kilogram (Nm/kg) | Standard Error 0.44 |
| CONTROL: Standard of Care Exercise | Hip, Knee, and Ankle Moments During Walking | Ankle Moment | 0.01 Newton-meters per kilogram (Nm/kg) | Standard Error 0.19 |
Comparison: Internal moment at the hipp-value: =0.16Mixed Models Analysis
Comparison: Internal moment at the kneep-value: =0.008Mixed Models Analysis
Comparison: Internal moment at the anklep-value: =0.877Mixed Models Analysis
Secondary
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.
Time frame: 6 weeks post-operative
Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Walking Speed | 1.20 meters/second | Standard Deviation 0.23 |
| CONTROL: Standard of Care Exercise | Walking Speed | 1.16 meters/second | Standard Deviation 0.2 |
p-value: =0.068Mixed Models Analysis
Secondary
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.
Time frame: 26 weeks post-operative
Population: At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Walking Speed | 1.29 meters/second | Standard Deviation 0.25 |
| CONTROL: Standard of Care Exercise | Walking Speed | 1.24 meters/second | Standard Deviation 0.13 |
p-value: =0.068Mixed Models Analysis
Secondary
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).
Time frame: 26 weeks post-operative
Population: At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) | 0.88 ratio | Standard Deviation 0.11 |
| CONTROL: Standard of Care Exercise | Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST) | 0.91 ratio | Standard Deviation 0.13 |
p-value: =0.511Mixed Models Analysis
Secondary
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).
Time frame: 26 weeks post-operative
Population: At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Weight-bearing Ratio During Walking | 0.98 ratio | Standard Deviation 0.06 |
| CONTROL: Standard of Care Exercise | Weight-bearing Ratio During Walking | 0.93 ratio | Standard Deviation 0.06 |
p-value: =0.402Mixed Models Analysis
Secondary
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).
Time frame: 6 weeks post-operative
Population: At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELOAD: Weight-bearing Biofeedback Exercise | Weight-bearing Ratio During Walking | 0.94 ratio | Standard Deviation 0.08 |
| CONTROL: Standard of Care Exercise | Weight-bearing Ratio During Walking | 0.92 ratio | Standard Deviation 0.09 |
p-value: =0.891Mixed Models Analysis