Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement - NCT00800254-80045 (Clinical Trial 256903)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy256903.aspx
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| City: |
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Aurora |
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State:
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CO |
| Zip Code: |
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80045 |
| Conditions: |
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Osteoarthritis |
| Purpose: |
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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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| Study summary: |
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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: |
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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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| Study is available at: |
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UCD Physical Therapy Program
Aurora, CO 80045
United States
Primary Contact:
Jackie Balter, MS
Email: Jackie.Balter@ucdenver.edu
Phone: 303-724-9590
Secondary Contact:
Jackie Balter, MS
Email: Jackie.Balter@ucdenver.edu
Phone: 303-724-9590 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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