Clinical Trial: Knee Stability Training for Knee Osteoarthritis (OA)

This study is currently recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

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.

Condition Treatment or Intervention Phase
Osteoarthritis
Joint Diseases
 Procedure: Traditional exercise therapy for knee osteoarthritis
 Procedure: Knee stability training
Phase II

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Knee Stability Training in Individuals with Knee Osteoarthritis

Further Study Details: 
Primary Outcomes: Western Ontario and McMaster OA index (WOMAC); Lower Extremity Function Scale; Get Up and Go test (a physical performance measure of function)
Expected Total Enrollment:  160

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.

Eligibility

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information


Pennsylvania
      University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences, Pittsburgh,  Pennsylvania,  15260,  United States; Recruiting
G. Kelley Fitzgerald, PhD, PT  412-383-6643    kfitzger@pitt.edu 
James J. Irrgang, PhD, PT, ATC  412-647-1237    jirrgang@pitt.edu 
G. Kelley Fitzgerald, PhD, PT,  Principal Investigator
James J. Irrgang, PhD, PT, ATC,  Sub-Investigator
Patrick Sparto, PhD, PT,  Sub-Investigator
Stephen Wisniewski, PhD,  Sub-Investigator
Chester V. Oddis, MD,  Sub-Investigator
Rakié Cham, PhD,  Sub-Investigator

Study chairs or principal investigators

G. Kelley Fitzgerald, PhD, PT,  Principal Investigator,  University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences   

More Information

Study ID Numbers:  NIAMS-117; R01 AR048760-01A2
Record last reviewed:  March 2005
Last Updated:  March 23, 2005
Record first received:  March 3, 2004
ClinicalTrials.gov Identifier:  NCT00078624
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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