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Completed

NCT Number: NCT00800254

Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCD Physical Therapy Program

Aurora, Colorado, 80045, United States

About this study

Osteoarthritis (OA) is a chronic degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. To alleviate pain and disability associated with knee OA, over 400,000 total knee arthroplasty (TKA) are performed each year in the United States, and future projections indicate that by the year 2030, more than 750,000 TKAs will be performed per year. While TKA reliably reduces pain and improves function, the recovery of force and function to normal levels is rare, which predisposes patients to future disability with increasing age. A month after TKA, impairments in quadriceps force are predominantly due to reflex inhibition, but are also influenced, to a lesser degree, by muscle atrophy. Neuromuscular electrical stimulation (NMES) may offer a promising alternative approach to override quadriceps reflex inhibition and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than voluntary exercise alone, especially when applied within the first days after surgery.

The overall goal of this study is to evaluate the efficacy of NMES initiated 48hrs after TKA as an adjunct to standard rehabilitation. NMES is expected to more effectively restore normal quadriceps muscle function to produce greater quadriceps force by decreasing reflex inhibition. Patients will be randomized into one of two rehabilitation groups: 1) the standard rehabilitation group or 2) standard rehabilitation + NMES.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 50-85 years of age
  • Scheduled for a primary unilateral TKA
  • Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Exclusion criteria

  • History of uncontrolled hypertension or uncontrolled diabetes
  • Body mass index greater than 35 kg/m^2
  • Neurological, vascular or cardiac problems that significantly limit function
  • Moderate or severe osteoarthritis or other orthopedic conditions in the non-operated lower extremity that limit function

Treatment and study plan

Neuromuscular Electrical Stimulation (NMES)

Device

NMES 20 minutes twice a day for 6 weeks plus standard physical therapy

Standard Rehabilitation Protocol

Other

Standard physical therapy for 8 weeks after surgery

Primary outcomes

  1. Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively

    Time frame: Baseline through 3.5 weeks

    A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.

Secondary outcomes

  1. Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively

    Time frame: Baseline through 1 year

    A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.

  2. Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively

    Time frame: 3.5 weeks post-operatively

    The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.

  3. Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively

    Time frame: 3.5 weeks post-operatively

    The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.

  4. Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively

    Time frame: 3.5 weeks post-operatively

    The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.

  5. Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively

    Time frame: 1 year post-operatively

    The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.

  6. Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively

    Time frame: 1 year post-operatively

    The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.

  7. Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively

    Time frame: 1 year post-operatively

    The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American College of Rheumatology Research and Education Foundation
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Dec 2, 2008
Registry last updated
Aug 11, 2015

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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