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Study data collection was terminated due to COVID-19 pandemic and will not resume.
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Nearly one out of every two Americans will develop knee osteoarthritis by age 85. Over 20 million Americans, including nearly three million Veterans, currently have painful knee arthritis that limits their daily activity or recreation. The vast majority of those individuals will be prescribed anti-inflammatory drugs that provide some pain relief but do not slow the progression of the disease. Often people with knee arthritis are told they must live with the pain until they become appropriate candidates for knee replacement surgery, but that can require tolerating the pain and limiting function for many years. Because of other health issues, some individuals are never acceptable surgery candidates. What is desperately needed are better conservative approaches for treating these patients. Two such approaches will be tested and compared in this study.
This study is a randomized controlled trial to investigate conservative treatments for individuals with painful knee osteoarthritis (OA). The study will recruit participants who have isolated, medial compartment knee OA. Subjects will be assigned to one of two gait training groups. Both groups will undergo gait analysis to determine their foot progression angle at their comfortable walking speed. Both groups will receive personalized gait retraining to either alter their foot progression angle or to achieve consistency of their natural foot progression angle.
Gait retraining will consist of once a week sessions for six weeks. The gait training will use a fading feedback approach, where the percentage of each weekly session during which feedback is used is decreased from week to week until no feedback is used by the last training session. Throughout the six-week training period subjects will be encouraged to practice their gait for at least ten minutes per day. Subjects will continue to practice their gait throughout the remainder of the 52-week intervention. Subjects will have their walking activity recorded using a 3-axis pedometer. Compared to their baseline walking activity, participants will be instructed to increase their daily walking by ten minutes per day throughout the 52-week intervention.
All subjects will receive monthly phone calls to encourage maintaining a regular walking regimen. Walking activity will be monitored periodically using a pedometer. Subjects will receive knee MRIs and weight-bearing knee radiographs at the start and end of the study. All participants will complete pain evaluations and clinical knee score questionnaires during the study. The investigators expect that subjects in both groups will have a reduction in knee pain over the course of the 52-week intervention. The primary objective of the study it to determine if the change in pain between baseline and week 52 is different between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait Training; Altered Foot Progression Angle | Experimental | Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle. |
|
| Gait Training; Consistent Foot Progression Angle | Experimental | Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait Training; Altered Foot Progression Angle | Other | Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medial Knee Pain | Change in medial knee pain between baseline and week 52 using an 11-point Numeric Rating Scale (NRS) to assess average medial knee pain over the past 7 day period. Possible scores range from 0 (no pain) to 10 (worst pain imaginable). Change = (Week 52 score - Baseline score). | Baseline and Week 52 |
| Change in Knee Adduction Moment | Change in magnitude of the more prominent peak in the knee adduction moment (KAM), a surrogate measure for medio-lateral load distribution in the knee, between baseline and week 52. A reduction in KAM indicates a shift in loading from the medial to the lateral compartment of the knee. Change = (Week 52 - Baseline). | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medial T1rho Relaxation Time | Change in T1rho relaxation time measured from quantitative MRI in the medial compartment of the knee between baseline and week 52. T1ρ relaxation time is sensitive to changes in proteoglycan content in the articular cartilage. Increased values of T1rho indicate increased depletion of proteoglycans and increased cartilage degeneration. Change = (Week 52 - Baseline). |
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Inclusion Criteria:
Exclusion Criteria:
The following criteria apply only to the affected osteoarthritic limb:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Kolesar, PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States | ||
| Stanford University, Depts: Bioengineering; Orthopaedics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40816302 | Derived | Uhlrich SD, Mazzoli V, Silder A, Finlay AK, Kogan F, Gold GE, Delp SL, Beaupre GS, Kolesar JA. Personalised gait retraining for medial compartment knee osteoarthritis: a randomised controlled trial. Lancet Rheumatol. 2025 Oct;7(10):e708-e718. doi: 10.1016/S2665-9913(25)00151-1. Epub 2025 Aug 12. |
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Interested individuals were initially screened via telephone or web-based questionnaire. Eligible individuals then underwent an in-person screen to confirm the location and severity of knee pain. Anterior-posterior weightbearing radiographs were obtained and given a KL grade. Participants who met the radiographic inclusion criteria were invited to the motion laboratory for a gait assessment. Those who were able to reduce their KAM peak by at least 5% with an FPA modification were randomized.
Participants were recruited via clinician referrals, approved searches of medical record databases, and advertisements in print media and online. The first participant was enrolled in August 2016 and the last participant was enrolled in June 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gait Training; Altered Foot Progression Angle | Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle. Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks. |
| FG001 | Gait Training; Consistent Foot Progression Angle | Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency. Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gait Training; Altered Foot Progression Angle | Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle. Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Medial Knee Pain | Change in medial knee pain between baseline and week 52 using an 11-point Numeric Rating Scale (NRS) to assess average medial knee pain over the past 7 day period. Possible scores range from 0 (no pain) to 10 (worst pain imaginable). Change = (Week 52 score - Baseline score). | Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 52 |
|
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Death, serious adverse events, and other (non-serious) adverse events were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gait Training; Altered Foot Progression Angle | Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback. The goal of the training is to encourage participants to adopt an altered foot progression angle in an attempt to alter the distribution of forces crossing the knee joint. Training will occur once a week for six weeks. This will be followed by a 46-week home and community-based walking program to practice and internalize the new personalized, gait pattern and to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to enhance internalization of the new foot progression angle. Gait Training; Altered Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks. |
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Enrollment was lower than expected due to the fact that most interested participants did not meet study inclusion criteria. As a result, we did not reach our pre-specified sample size of 80 participants. In addition, the institutional shutdown due to the COVID-19 pandemic resulted in 7 participants not completing the full 1-year intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Kolesar, PhD | Stanford University | 614-561-1563 | julie14@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2021 | Sep 23, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 29, 2019 | Sep 23, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Gait Training; Consistent Foot Progression Angle | Other | Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks. |
|
| Baseline and Week 52 |
| Change in Medial T2 Relaxation Time | Change in T2 relaxation time measured from quantitative MRI in the medial compartment of the knee between baseline and week 52. T2 relaxation time is sensitive to changes in water content and collagen matrix integrity of the articular cartilage. Increased values of T2 indicate increased cartilage degeneration. Change = (Week 52 - Baseline). | Baseline and Week 52 |
| Change in Lateral T1rho Relaxation Time | Change in T1rho relaxation time measured from quantitative MRI in the lateral compartment of the knee between baseline and week 52. T1ρ relaxation time is sensitive to changes in proteoglycan content in the articular cartilage. Increased values of T1rho indicate increased depletion of proteoglycans and increased cartilage degeneration. Change = (Week 52 - Baseline). | Baseline and Week 52 |
| Change in Lateral T2 Relaxation Time | Change in T2 relaxation time measured from quantitative MRI in the lateral compartment of the knee between baseline and week 52. T2 relaxation time is sensitive to changes in water content and collagen matrix integrity of the articular cartilage. Increased values of T2 indicate increased cartilage degeneration. Change = (Week 52 - Baseline). | Baseline and Week 52 |
| Stanford |
| California |
| 94305 |
| United States |
| Increased pain |
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| Withdrawal by Subject |
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| Unrelated medical issue |
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| Received intra-articular injection |
|
| BG001 | Gait Training; Consistent Foot Progression Angle | Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency. Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Kellgren-Lawrence classification of knee OA | Classification of knee OA using 5 grades ranging from 0 (no presence of OA) to 4 (severe OA) | Count of Participants | Participants |
|
| NRS pain, medial | Medial compartment knee pain assessed using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). | Mean | Standard Deviation | units on a scale |
|
| KAM peak, natural FPA | Peak knee adduction moment (KAM), a surrogate measure for medio-lateral load distribution in the knee, measured when walking with a natural foot progression angle (FPA). A reduction in KAM indicates a shift in loading from the medial to the lateral compartment of the knee. | Mean | Standard Deviation | %Bodyweight*Height |
|
| KAM peak, target FPA | Peak knee adduction moment (KAM), a surrogate measure for medio-lateral load distribution in the knee, measured when walking with the target foot progression angle (FPA). A reduction in KAM indicates a shift in loading from the medial to the lateral compartment of the knee. | Mean | Standard Deviation | %Bodyweight*Height |
|
| WOMAC pain | Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a self-report questionnaire to evaluate knee OA. The possible score range for the Pain subscale is 0-20. The raw scores were then normalized to a range of 0-100, with higher scores indicating worse pain. | Mean | Standard Deviation | units on a scale |
|
| WOMAC function | Physical Function subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a self-report questionnaire to evaluate knee OA. The possible score range for the Physical Function subscale is 0-68. The raw scores were then normalized to a range of 0-100, with higher scores indicating worse function. | Mean | Standard Deviation | units on a scale |
|
| Daily steps | Daily steps measured and averaged over one week using a pedometer carried by the participant. | Mean | Standard Deviation | steps/day |
|
| OG001 | Gait Training; Consistent Foot Progression Angle | Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency. Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks. |
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| Primary | Change in Knee Adduction Moment | Change in magnitude of the more prominent peak in the knee adduction moment (KAM), a surrogate measure for medio-lateral load distribution in the knee, between baseline and week 52. A reduction in KAM indicates a shift in loading from the medial to the lateral compartment of the knee. Change = (Week 52 - Baseline). | Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables. | Posted | Mean | Standard Deviation | %Bodyweight*Height | Baseline and Week 52 |
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| Secondary | Change in Medial T1rho Relaxation Time | Change in T1rho relaxation time measured from quantitative MRI in the medial compartment of the knee between baseline and week 52. T1ρ relaxation time is sensitive to changes in proteoglycan content in the articular cartilage. Increased values of T1rho indicate increased depletion of proteoglycans and increased cartilage degeneration. Change = (Week 52 - Baseline). | Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables. | Posted | Mean | Standard Deviation | ms | Baseline and Week 52 |
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| Secondary | Change in Medial T2 Relaxation Time | Change in T2 relaxation time measured from quantitative MRI in the medial compartment of the knee between baseline and week 52. T2 relaxation time is sensitive to changes in water content and collagen matrix integrity of the articular cartilage. Increased values of T2 indicate increased cartilage degeneration. Change = (Week 52 - Baseline). | Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables. | Posted | Mean | Standard Deviation | ms | Baseline and Week 52 |
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| Secondary | Change in Lateral T1rho Relaxation Time | Change in T1rho relaxation time measured from quantitative MRI in the lateral compartment of the knee between baseline and week 52. T1ρ relaxation time is sensitive to changes in proteoglycan content in the articular cartilage. Increased values of T1rho indicate increased depletion of proteoglycans and increased cartilage degeneration. Change = (Week 52 - Baseline). | Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables. | Posted | Mean | Standard Deviation | ms | Baseline and Week 52 |
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| Secondary | Change in Lateral T2 Relaxation Time | Change in T2 relaxation time measured from quantitative MRI in the lateral compartment of the knee between baseline and week 52. T2 relaxation time is sensitive to changes in water content and collagen matrix integrity of the articular cartilage. Increased values of T2 indicate increased cartilage degeneration. Change = (Week 52 - Baseline). | Intent-to-treat population. Missing data were imputed using the Markov chain Monte Carlo method for continuous variables. | Posted | Mean | Standard Deviation | ms | Baseline and Week 52 |
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| EG001 | Gait Training; Consistent Foot Progression Angle | Participants will receive personalized gait training while walking on a treadmill with haptic feedback. The goal of the training is to encourage participants to maintain a consistent foot progression angle in an attempt to minimize the variability in the forces crossing the knee joint. Training will occur once a week, for 6 weeks. This will be followed by a 46-week home and community-based walking program to encourage daily walking. Refresher training with haptic feedback will be offered at weeks 11, 25 and 39 to maintain foot progression angle consistency. Gait Training; Consistent Foot Progression Angle: Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
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