Gait Modification and Knee Joint Load

October 31, 2023 updated by: Alison Chang, Northwestern University

The Effect of Gait Modification on Knee Joint Load in Persons With Medial Tibiofemoral Osteoarthritis - A Pilot Study

This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
  • reporting average knee pain on walking > 3 on an 11-point scale (0-10) in at least one knee
  • pain or tenderness predominantly located on the medial knee.

Exclusion Criteria:

  • medial TF joint space width greater than lateral
  • Kellgren/Lawrence (K/L) grade 4
  • knee surgery or intra-articular corticosteroid injection in the past 6 months
  • uncomfortable walking on treadmill for 20 minutes
  • unable to walk without a walking aide
  • inflammatory arthritis
  • other musculoskeletal or neurological disorders that affect gait patterns
  • currently receiving physical therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait modification
In this pilot study, participants modify their gait patterns guided by real-time visual feedback on their medial knee load while walking on an instrumented treadmill.
Other: Gait modification
Individualized gait modifications guided by real-time visual feedback of knee load

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External knee adduction moment during walking
Time Frame: Baseline-to-6-week change
The external knee adduction moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee adduction moment during walking.
Baseline-to-6-week change
WOMAC (Western Ontario and McMaster Universities) score
Time Frame: Baseline-to-6-week change
WOMAC questionnaire contains 24 questions in three domains of pain (score range 0-20), stiffness (score range 0-8) and physical function (score range 0-68). Higher score indicates worse symptom/function.
Baseline-to-6-week change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External knee flexion moment during walking
Time Frame: Baseline-to-6-week change
The external knee flexion moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee flexion moment during walking.
Baseline-to-6-week change
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time Frame: Baseline-to-6-week change
KOOS questionnaire contains 42 items in 5 domains of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.
Baseline-to-6-week change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Alison H Chang, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00212048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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