Electrical Stimulation After Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Center for Medical Rehabilitation Research (NCMRR)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00224913
First received: September 21, 2005
Last updated: October 11, 2005
Last verified: October 2005
  Purpose

Total knee arthroplasty (TKA) is performed more than 300,000 times a year in the United States, most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the development and progression of knee OA and is a significant problem after TKA. Voluntary exercise has been ineffective at restoring quadriceps strength after TKA. The aims of this study are: 1) to assess the effectiveness of high-level neuromuscular electrical stimulation as an adjunct to ongoing intensive, early rehabilitation in restoring quadriceps strength and improving the functional outcome after primary TKA, and 2) to identify the physiological and morphological bases for improvements in quadriceps strength and functional outcome.


Condition Intervention Phase
Total Knee Arthroplasty
Osteoarthritis
Procedure: Neuromuscular electrical stimulation
Procedure: Voluntary exercise
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: NMES for Older Individuals After Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Quadriceps Strength
  • Quadriceps Activation
  • Functional Tests

Secondary Outcome Measures:
  • Self reports of function

Estimated Enrollment: 200
Study Start Date: March 2002
Detailed Description:

Reduced muscle strength from illness or injuries often leads to loss of function and independence in the elderly. The recovery of muscle strength and function in disabled elderly individuals is a major challenge in rehabilitation. The etiology of the muscle weakness with injury or age is not fully elucidated. Training programs designed to maximize strength gains in young individuals may not be optimal in the elderly because the cause of the weakness and the morphology of the muscle may be different for young vs. old people. The overall goal of this work is to determine if physiologically and morphologically based rehabilitation programs are more effective than traditional rehabilitation to counter changes in muscle strength and function in older individuals. Neuromuscular electrical stimulation (NMES) may be used to improve strength and function following injury or surgery. This study provides motivation for exploring the use of NMES with the elderly. We posit that using NMES to augment a traditional rehabilitation program for elderly patients with osteoarthritis following total knee arthroplasties (TKA) will result in greater strength and functional gains than using only traditional rehabilitation. Elderly patients with osteoarthritis who undergo TKAs serve as ideal subjects for testing the effectiveness of rehabilitation programs become those patients almost always exhibit marked quadriceps weakness that is resistant to traditional physical rehabilitation. More than 300,000 TKAs are performed each year in the United States to treat osteoarthritis of the knee in older individuals. So, the successful rehabilitation of elder patients following TKA is an important and challenging problem. The specific aims of this proposal are: 1) To assess the effectiveness of high-level neuromuscular electrical stimulation is an adjunct to ongoing intensive, early rehabilitation in restoring quadriceps strength and improving the functional outcome after primary TKA, and 2) To identify the physiological and morphological bases for improvements in quadriceps strength and functional outcome

A total of 200 subjects will participate in this study. Functional and strength testing provides information for the patients’ clinical treatment and allow us to monitor their progress. This information will also help in the design of a training program for individuals following a total knee replacement that optimizes the return to full level of function after surgery. MRI screening will provide information regarding the size of the thigh muscle at various periods throughout rehabilitation. It will enable us to assess the impact of post-operative treatment on increasing the size of the thigh muscle. Patients will be asked to participate in functional and strength testing sessions, lasting about 1½ hours, at the following times: 0-2 weeks before surgery, 3-4 weeks, 6-7 weeks, 10-12 weeks, 6 months, 1 year, and 2 years after surgery. MRI testing will last about 30 minutes per session and will be performed 0-2 weeks before surgery, and 3-4 weeks, 10-12 weeks, and 1 year after surgery.

Functional testing will include 5 parts: a timed walking test, a timed stair climbing test, a timed balance test, a timed step test, and a six-minute walk test. A strength test will be used to assess the strength of the thigh muscles.

The second part of this study involves treatment. Patients participate in 6 weeks of physical therapy, 3 times per week. They are randomly assigned to one of 2 groups. One group will participate in a traditional rehabilitation program. The other group will receive electrical stimulation for strengthening of the thigh muscle in addition to the traditional rehabilitation program.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • TKA for unilateral tricompartmental knee OA

Exclusion Criteria:

  • Insulin dependent diabetes
  • neurological conditions
  • other lower extremity orthopedic problems that affect function
  • BMI>40
  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: NCT00224913

Contacts
Contact: Lynn Snyder-Mackler, PT, ScD 302-831-3613 smack@udel.edu

Locations
United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19716
Contact: Lynn Snyder-Mackler, PT, ScD    302-831-3613    smack@udel.edu   
Sponsors and Collaborators
National Center for Medical Rehabilitation Research (NCMRR)
Investigators
Principal Investigator: Lynn Snyder-Mackler, PT, ScD University of Delaware
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00224913     History of Changes
Other Study ID Numbers: 5R01HD041055
Study First Received: September 21, 2005
Last Updated: October 11, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
osteoarthritis
quadriceps
inhibition
functional outcome
electrical stimulation

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

ClinicalTrials.gov processed this record on September 18, 2014