Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767570
Recruitment Status : Active, not recruiting
First Posted : May 10, 2016
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Gait Training; Altered Foot Progression Angle Other: Gait Training; Consistent Foot Progression Angle Not Applicable

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, and smart shoes that will log their foot progression angle under free-living conditions. 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 there is change in pain between baseline and week 52 is different between the two groups.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Personalized Gait Training With Feedback to Reduce Knee Pain From Osteoarthritis
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.

Experimental: 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.
Other: 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.




Primary Outcome Measures :
  1. Knee adduction moment [ Time Frame: Change between baseline and week 52 ]
    Change in magnitude of the more prominent peak in the knee adduction moment profile between baseline and week 52

  2. Change in Knee Pain [ Time Frame: Change between baseline and week 52 ]
    Visual Analog and/or Numeric Rating Scale for knee pain assessed


Secondary Outcome Measures :
  1. Cartilage thinning [ Time Frame: Change between baseline and week 52 ]
    Change in cartilage thickness between baseline and week 52

  2. Cartilage MRI properties [ Time Frame: Change between baseline and week 52 ]
    Change in cartilage properties assessed via MRI between baseline and week 52



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767570


Locations
Layout table for location information
United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Stanford University, Depts: Bioengineering; Orthopaedics
Stanford, California, United States, 94305
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Julie Kolesar, PhD VA Palo Alto Health Care System, Palo Alto, CA
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02767570    
Other Study ID Numbers: O1811-R
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases