Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Procedure: Neuromuscular Electrical Stimulation (NMES) Behavioral: Standard Rehabilitation Protocol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement |
- Changes in quadriceps muscle force [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
- Changes in quadriceps activation and size,quadriceps muscle activity (EMG) during functional activities [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
- Functional performance measures (self-reports, 6 minute walk distance, get up and go time, and functional stair climbing time) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | October 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Neuromuscular Electrical Stimulation (NMES)
20 minutes twice a day for 6 weeks
Behavioral: Standard Rehabilitation Protocol
Standard physical therapy for 8 weeks after surgery
|
| Active Comparator: 2 |
Behavioral: Standard Rehabilitation Protocol
Standard physical therapy for 8 weeks after surgery
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Colorado | |
| UCD Physical Therapy Program | |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: | Jennifer Stevens, MPT, PhD | University of Colorado, Denver |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00800254 History of Changes |
| Other Study ID Numbers: | 06-0074, K23AG029978-01A2 |
| Study First Received: | November 30, 2008 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Colorado, Denver:
|
electrical stimulation total knee arthroplasty quadriceps muscle arthroscopy |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013