OsteoarthritisNCT02767570
Long-Term Effectiveness of Walking Training in Patients With Knee Osteoarthritis
A study testing Gait Training; Altered Foot Progression Angle and Gait Training; Consistent Foot Progression Angle in people with Osteoarthritis, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Gait Training; Altered Foot Progression Angle and Gait Training; Consistent Foot Progression Angle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2016to 31 Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with isolated, medial compartment knee OA of at least six months duration
- Kellgren-Lawrence grade of I, II, or III
- Age greater than 18 years at the time of enrollment
- Ability to give informed consent
- Knee pain more than three days per week on average
- Average knee pain in medial compartment between 3 and 9 on an 11-point Numerical Rating Scale, and greater than pain in other compartments
Show all 10Show fewer
- Ambulatory without aids
- Able to walk for at least 25 consecutive minutes
- Able to walk on treadmill safely at 0.7 m/s or faster
- Able to reduce the prominent peak of the knee adduction moment by changing foot progression angle
Who cannot join
- Body mass index equal to or greater than 35
- Pregnancy
- Plans for knee replacement within the next 12 months
- Contraindications to MRI
- Nerve or muscle disease associated with walking difficulty
- Narcotic pain medication usage
Show all 26Show fewer
- History of rheumatoid arthritis or autoimmune disease
- An episode of gout or pseudogout in the knee in the past year
- History of neuropathic arthropathy, infectious disease, or other major systemic diseases
- Current or recent past use (within two months) of oral corticosteroids
- Cognitive impairments that would limit a subject's understanding
- Expecting a significant change in activity level or weight within the next 12 months
- Regularly participates in high impact activities such as running, soccer, basketball, etc.
- Unable to perform the 3rd stage of the 4-stage balance test, which involves holding a tandem stance for 10 seconds
- The following criteria apply only to the affected osteoarthritic limb:
- History of symptomatic arthritis in lower limb joints other than the knees that is more severe than knee arthritis
- Replacement of any lower extremity joint
- Lateral tibiofemoral joint space width less than medial
- Recurrent giving way of the knee
- Symptoms arising primarily from a meniscal or ligament pathology or other structure not directly related to osteoarthritis as identified by physical exam, health record, or MRI
- Symptoms originating primarily from the patellofemoral joint
- Avascular necrosis
- Recent (within two months) knee injury or surgery
- Planned use of hinged knee brace in next 12 months
- Severe knee malalignment of more than 10 degrees from neutral
- Intra-articular injection within the past 2 months or planned for the next 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
Stanford University, Depts: Bioengineering; Orthopaedics
Stanford, California, 94305
About this study
Official title: Personalized Gait Training With Feedback to Reduce Knee Pain From Osteoarthritis
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis
- Being tested
- Gait Training; Altered Foot Progression Angle, Gait Training; Consistent Foot Progression Angle
- Keywords
- Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Training; Altered Foot Progression AngleOther
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.
Gait Training; Consistent Foot Progression AngleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gait Training; Altered 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. Receives: Other: Gait Training; Consistent Foot Progression Angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and Week 52
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: Study data collection was terminated due to COVID-19 pandemic and will not resume.
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 (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie Kolesar, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767570
- Sponsor's protocol ID
- O1811-R
- Status last verified
- Feb 2022
- First submitted
- 4 May 2016
- Last updated
- 15 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40816302
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Gait Training With Feedback to Reduce Knee Pain From Osteoarthritis
- ClinicalTrials.gov ID
- NCT02767570
- Acronym / sponsor ID
- O1811-R
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study data collection was terminated due to COVID-19 pandemic and will not resume.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 15 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait Training; Altered Foot Progression Angle | Experimental | Other: Gait Training; Altered Foot Progression AngleParticipants 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 | Other: Gait Training; Consistent Foot Progression AngleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with isolated, medial compartment knee OA of at least six months duration
- Kellgren-Lawrence grade of I, II, or III
- Age greater than 18 years at the time of enrollment
- Ability to give informed consent
- Knee pain more than three days per week on average
Key exclusion criteria (26 listed)
- Body mass index equal to or greater than 35
- Pregnancy
- Plans for knee replacement within the next 12 months
- Contraindications to MRI
- Nerve or muscle disease associated with walking difficulty
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 |
|---|---|---|
| Gait Training; Altered Foot Progression AngleParticipants 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. | Other | Gait Training; Altered Foot Progression Angle |
| Gait Training; Consistent Foot Progression AngleParticipants 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. | Other | Gait Training; Consistent Foot Progression Angle |
Primary outcome
Change in Medial Knee Pain
Time frame: Baseline and Week 52
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).
Change in Knee Adduction Moment
Time frame: Baseline and Week 52
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).
4 secondary outcomes
Change in Medial T1rho Relaxation Time
Time frame: Baseline and Week 52
Change in Medial T2 Relaxation Time
Time frame: Baseline and Week 52
Change in Lateral T1rho Relaxation Time
Time frame: Baseline and Week 52
Change in Lateral T2 Relaxation Time
Time frame: Baseline and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40816302Uhlrich 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.
- Individual participant dataSharing planned: No
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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.
Julie Kolesar, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training; Altered Foot Progression Angle and Gait Training; Consistent Foot Progression Angle in people with Osteoarthritis, run by VA Office of Research and Development at 2 sites 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 10 inclusion and 26 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: stopped early, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 15 Apr 2022). 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?
Change in Medial Knee Pain (time frame: Baseline and Week 52). The study lists 2 primary outcomes in all. 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 NCT02767570, which also lists 1 linked publication.
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 15 Apr 2022.