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Electrical Stimulation After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT00224913
Recruitment Status : Unknown
Verified October 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : September 23, 2005
Last Update Posted : October 12, 2005
Sponsor:
Collaborator:
National Center for Medical Rehabilitation Research (NCMRR)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 23, 2005
Last Update Posted Date October 12, 2005
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
  • Quadriceps Strength
  • Quadriceps Activation
  • Functional Tests
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00224913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
Self reports of function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Stimulation After Total Knee Arthroplasty
Official Title  ICMJE NMES for Older Individuals After Total Knee Arthroplasty
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Total Knee Arthroplasty
  • Osteoarthritis
Intervention  ICMJE
  • Procedure: Neuromuscular electrical stimulation
  • Procedure: Voluntary exercise
Study Arms Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 21, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224913
Other Study ID Numbers  ICMJE 5R01HD041055( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE National Center for Medical Rehabilitation Research (NCMRR)
Investigators  ICMJE
Principal Investigator: Lynn Snyder-Mackler, PT, ScD University of Delaware
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP