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

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Neuromuscular Electrical Stimulation (NMES); Other: Standard Rehabilitation Protocol

• Registration Number: NCT00800254
• Lead Sponsor: University of Colorado, Denver

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 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

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-30
• Study First Submitted QC: 2008-11-30
• Study First Posted: 2008-12-02
• Primary Completion: 2010-12
• Study Completion: 2011-11
• Results First Submitted: 2015-05-28
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Results First Posted: 2015-08-11
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular Electrical Stimulation (NMES)	Neuromuscular Electrical Stimulation (NMES)	-
Standard Rehabilitation Protocol	Standard Rehabilitation Protocol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively	Baseline through 1 year	A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively	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.
Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively	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.
Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively	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.
Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively	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.
Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively	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.
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively	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.

Trial Locations

Locations (1)

UCD Physical Therapy Program; 🇺🇸 Aurora, Colorado, United States