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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
American College of Rheumatology Research and Education Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00800254
First received: November 30, 2008
Last updated: July 14, 2015
Last verified: July 2015
  Purpose
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.

Condition Intervention Phase
Osteoarthritis
Device: Neuromuscular Electrical Stimulation (NMES)
Other: Standard Rehabilitation Protocol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively [ Time Frame: Baseline through 3.5 weeks ] [ Designated as safety issue: No ]
    A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.


Secondary Outcome Measures:
  • Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively [ Time Frame: Baseline through 1 year ] [ Designated as safety issue: No ]
    A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.

  • Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively [ Time Frame: 3.5 weeks post-operatively ] [ Designated as safety issue: No ]
    The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.

  • Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively [ Time Frame: 3.5 weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively [ Time Frame: 3.5 weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.

  • Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    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.

  • Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neuromuscular Electrical Stimulation (NMES) Device: Neuromuscular Electrical Stimulation (NMES)
NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
Active Comparator: Standard Rehabilitation Protocol Other: Standard Rehabilitation Protocol
Standard physical therapy for 8 weeks after surgery

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800254

Locations
United States, Colorado
UCD Physical Therapy Program
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
American College of Rheumatology Research and Education Foundation
Investigators
Principal Investigator: Jennifer Stevens, MPT, PhD University of Colorado, Denver
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00800254     History of Changes
Other Study ID Numbers: 06-0074  K23AG029978-01A2 
Study First Received: November 30, 2008
Results First Received: May 28, 2015
Last Updated: July 14, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
electrical stimulation
total knee arthroplasty
quadriceps
muscle
arthroscopy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 27, 2016