Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
2 other identifiers
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 30, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
August 11, 2015
CompletedAugust 11, 2015
July 1, 2015
2.2 years
November 30, 2008
May 28, 2015
July 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively
Baseline through 1 year
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively
3.5 weeks post-operatively
Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively
3.5 weeks post-operatively
Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively
3.5 weeks post-operatively
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively
1 year post-operatively
- +2 more secondary outcomes
Study Arms (2)
Neuromuscular Electrical Stimulation (NMES)
EXPERIMENTALStandard Rehabilitation Protocol
ACTIVE COMPARATORInterventions
NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
Standard physical therapy for 8 weeks after surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCD Physical Therapy Program
Aurora, Colorado, 80045, United States
Related Publications (5)
Mintken PE, Carpenter KJ, Eckhoff D, Kohrt WM, Stevens JE. Early neuromuscular electrical stimulation to optimize quadriceps muscle function following total knee arthroplasty: a case report. J Orthop Sports Phys Ther. 2007 Jul;37(7):364-71. doi: 10.2519/jospt.2007.2541.
PMID: 17710905BACKGROUNDMizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
PMID: 15866968BACKGROUNDMizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.
PMID: 16078331BACKGROUNDStevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Schwartz RS, Schenkman M, Kohrt WM. Relationship between intensity of quadriceps muscle neuromuscular electrical stimulation and strength recovery after total knee arthroplasty. Phys Ther. 2012 Sep;92(9):1187-96. doi: 10.2522/ptj.20110479. Epub 2012 May 31.
PMID: 22652985DERIVEDStevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17.
PMID: 22095207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Stevens-Lapsley, PhD
- Organization
- University of Colorado Denver
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Stevens, MPT, PhD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2008
First Posted
December 2, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2010
Study Completion
November 1, 2011
Last Updated
August 11, 2015
Results First Posted
August 11, 2015
Record last verified: 2015-07