Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
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| First Received Date ICMJE | November 30, 2008 | ||||
| Last Updated Date | November 20, 2012 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in quadriceps muscle force [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Changes in quadriceps muscle force [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00800254 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement | ||||
| Official Title ICMJE | Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | ||||
| Intervention ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 66 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00800254 | ||||
| Other Study ID Numbers ICMJE | 06-0074, K23AG029978-01A2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Colorado, Denver | ||||
| Study Sponsor ICMJE | University of Colorado, Denver | ||||
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| Information Provided By | University of Colorado, Denver | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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