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NCT Number: NCT04946136

Gait Modification and Knee Joint Load

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).

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Key information

Conditions

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

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait modification

Other

Individualized gait modifications guided by real-time visual feedback of knee load

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2021
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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