Phase 2
Completed N=66
Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
Source: ClinicalTrials.gov NCT00800254 ↗Enrolled (actual)
66
Serious AEs
9.1%
Results posted
Aug 2015
Primary outcomePrimary: Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively — -0.40; -0.67 change in N-m/kg — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively |
-0.40; -0.67 | <0.001 sig |
| SECONDARY Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively |
0.33; 0.18 | — |
| SECONDARY Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively |
390.1; 295.3 | <0.003 sig |
| SECONDARY Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively |
10.4; 13.9 | — |
| SECONDARY Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively |
25.2; 39.3 | — |
| SECONDARY Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively |
524.6; 477.8 | — |
| SECONDARY Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively |
6.7; 8.3 | — |
| SECONDARY Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively |
11.5; 14.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00800254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.