Long-Term Effectiveness of Walking Training in Patients With Knee Osteoarthritis

NCT02767570 | Terminated Results

• 1 other identifier: O1811-R
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change in Medial T1rho Relaxation Time

  Baseline and Week 52

• Change in Medial T2 Relaxation Time

  Baseline and Week 52

• Change in Lateral T1rho Relaxation Time

  Baseline and Week 52

• Change in Lateral T2 Relaxation Time

  Baseline and Week 52

Study Arms (2)

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.

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.

Other: Gait Training; Consistent Foot Progression Angle

Interventions

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.

Gait Training; Altered Foot Progression Angle

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.

Gait Training; Consistent Foot Progression Angle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Stanford University, Depts: Bioengineering; Orthopaedics

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 40816302 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Julie Kolesar, PhD
• Organization: Stanford University

julie14@stanford.edu

614-561-1563

Study Officials

• Julie Kolesar, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 10, 2016
• Study Start: August 1, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: April 15, 2022
• Results First Posted: April 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)