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Completed

NCT Number: NCT00078624

Knee Stability Training for Knee Osteoarthritis (OA)

People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.

Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

Pittsburgh, Pennsylvania, 15260, United States

About this study

Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.

Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
  • Grade II or greater Kellgren and Lawrence radiographic changes

Exclusion criteria

  • History of two or more falls within the year prior to study entry
  • Unable to walk a distance of 100 feet without an assistive device or a rest period
  • Total knee arthroplasty
  • Uncontrolled hypertension
  • History of cardiovascular disease
  • History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
  • Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
  • Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
  • Pregnancy

Treatment and study plan

Traditional exercise therapy for knee osteoarthritis

Other

Exercises include stretching, strengthening, and aerobic exercise

Knee stability training

Other

The addition of agility and perturbation training techniques to the traditional exercise program

Primary outcomes

  1. Western Ontario and McMaster OA index (WOMAC)

    Time frame: Measured at baseline, 2 months, 6 months, 1 year

  2. Lower Extremity Function Scale

    Time frame: Measured at baseline, 2 months, 6 months, 1 year

  3. Get Up and Go test (a physical performance measure of function)

    Time frame: Measured at baseline, 2 months, 6 months

  4. Knee Outcome Survey - Activities of Daily Living Scale

    Time frame: Measured at baseline, 2 months, 6 months, 1 year

Secondary outcomes

  1. Cartilage morphology changes as measured by MRI

    Time frame: Measured at baseline, 1 year

  2. Physical Activity Scale for the Elderly

    Time frame: Measured at baseline, 2 months, 6 months, 1 year

  3. Quadriceps strength and activation

    Time frame: Measured at baseline, 2 months, 6 months

  4. Radiographic severity of OA

    Time frame: Measured at baseline, 1 year

  5. Fear Avoidance questionnaire for the knee

    Time frame: Measured at baseline, 2months, 6 months, 1 year

  6. Beck Anxiety Index

    Time frame: Measured at baseline, 2 months, 6 months, 1 year

  7. Center for Epidemiological Studies Depression Scale

    Time frame: Measured at baseline, 2 months, 6 months, 1 year

  8. Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)

    Time frame: Measured at baseline, 2 months, 6 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Knee Stability Training in Individuals With Knee Osteoarthritis

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 4, 2004
Registry last updated
Jan 24, 2013

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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