Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

Study Overview
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Brief Summary
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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 arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

Detailed Description
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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.

Official Title
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Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Neuromuscular Electrical Stimulation (NMES)
* Other: Standard Rehabilitation Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-85 years of age Scheduled for a primary unilateral TKA Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study Exclusion Criteria: History of uncontrolled hypertension or uncontrolled diabetes Body mass index greater than 35 kg/m^2 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular Electrical Stimulation (NMES)<br> | Device: Neuromuscular Electrical Stimulation (NMES)<br>* NMES 20 minutes twice a day for 6 weeks plus standard physical therapy<br>|
| Active Comparator: Standard Rehabilitation Protocol<br> | Other: Standard Rehabilitation Protocol<br>* Standard physical therapy for 8 weeks after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. | Baseline through 3.5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. | Baseline through 1 year | 
| Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively | The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval. | 3.5 weeks post-operatively | 
| Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively | The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance. | 3.5 weeks post-operatively | 
| Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively | The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs. | 3.5 weeks post-operatively | 
| Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively | The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval. | 1 year post-operatively | 
| Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively | The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance. | 1 year post-operatively | 
| Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively | The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs. | 1 year post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical stimulation, total knee arthroplasty, quadriceps, muscle, arthroscopy