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Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement - NCT00800254-80045(Clinical Trial 256903)



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City:  Aurora
State:  
CO
Zip Code: 80045
Conditions: Osteoarthritis
Purpose: The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee replacement (TKR) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.
Study summary: 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.
Criteria: Inclusion Criteria: - 50 years of age or older - Scheduled for a unilateral or bilateral primary TKR - Body mass index less than 35 - Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study Exclusion Criteria: - History of uncontrolled diabetes; HbA1c levels greater than 8% - 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 - Alcoholism or drug abuse
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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