Recruiting
Phase 1

Electrical Stimulation

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00224913

Conditions

Total Knee Arthroplasty

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Neuromuscular electrical stimulation

Voluntary exercise

Study Details

Brief summary:

Total knee arthroplasty (TKA) is performed more than 300,000 times a year in the United States, most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the development and progression of knee OA and is a significant problem after TKA. Voluntary exercise has been ineffective at restoring quadriceps strength after TKA. The aims of this study are: 1) to assess the effectiveness of high-level neuromuscular electrical stimulation as an adjunct to ongoing intensive, early rehabilitation in restoring quadriceps strength and improving the functional outcome after primary TKA, and 2) to identify the physiological and morphological bases for improvements in quadriceps strength and functional outcome.

Conditions

Total Knee Arthroplasty

Osteoarthritis

Study ID

NCT00224913

Start date

Mar, 2002

Status verified date

Oct, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • TKA for unilateral tricompartmental knee OA

Exclusion Criteria:

  • Insulin dependent diabetes
  • neurological conditions
  • other lower extremity orthopedic problems that affect function
  • BMI>40

Study Design

Enrollment

200 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Neuromuscular electrical stimulation

Voluntary exercise

Primary outcome measure

  • Quadriceps Strength [ Time Frame: undefined ]
  • Quadriceps Activation [ Time Frame: undefined ]
  • Functional Tests [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Lynn Snyder-Mackler, PT, ScD

302-831-3613smack@udel.edu

Locations

University of Delaware

Recruiting

Newark, Delaware, United States, 19716

Contacts

Lynn Snyder-Mackler, PT, ScD

302-831-3613smack@udel.edu

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Oct 12, 2005

Last verified

Oct, 2005

Keywords

  • osteoarthritis
  • quadriceps
  • inhibition
  • functional outcome
  • electrical stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2005-10-12.