Trial Outcomes & Findings for Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement (NCT NCT00800254)
NCT ID: NCT00800254
Last Updated: 2015-08-11
Results Overview
A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.
COMPLETED
PHASE2
66 participants
Baseline through 3.5 weeks
2015-08-11
Participant Flow
Participant milestones
| Measure |
Neuromuscular Electrical Stimulation (NMES)
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
|
Overall Study
3.5 Weeks Post-operatively
|
31
|
31
|
|
Overall Study
COMPLETED
|
30
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=35 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=31 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.1 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 3.5 weeksPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=35 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=31 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively
|
-0.40 change in N-m/kg
Standard Error 0.05
|
-0.67 change in N-m/kg
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline through 1 yearPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=30 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=25 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively
|
0.33 change in N-m/kg
Standard Deviation 0.52
|
0.18 change in N-m/kg
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 3.5 weeks post-operativelyPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=31 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=24 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively
|
390.1 meters
Standard Deviation 92.4
|
295.3 meters
Standard Deviation 103.4
|
SECONDARY outcome
Timeframe: 3.5 weeks post-operativelyPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
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.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=31 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=28 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively
|
10.4 seconds
Standard Deviation 3.8
|
13.9 seconds
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 3.5 weeks post-operativelyPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
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.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=30 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=28 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively
|
25.2 seconds
Standard Deviation 10.4
|
39.3 seconds
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 1 year post-operativelyPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=29 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=25 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively
|
524.6 meters
Standard Deviation 81.6
|
477.8 meters
Standard Deviation 94.0
|
SECONDARY outcome
Timeframe: 1 year post-operativelyPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
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.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=29 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=25 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively
|
6.7 seconds
Standard Deviation 1.7
|
8.3 seconds
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 1 year post-operativelyPopulation: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
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.
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=29 Participants
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol (Control)
n=25 Participants
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively
|
11.5 seconds
Standard Deviation 4.3
|
14.8 seconds
Standard Deviation 9.3
|
Adverse Events
Neuromuscular Electrical Stimulation (NMES)
Standard Rehabilitation Protocol
Serious adverse events
| Measure |
Neuromuscular Electrical Stimulation (NMES)
n=35 participants at risk
Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
|
Standard Rehabilitation Protocol
n=31 participants at risk
Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
|
|---|---|---|
|
Surgical and medical procedures
Post-op complication
|
2.9%
1/35 • Adverse event data were collected for a period of 1 year.
|
0.00%
0/31 • Adverse event data were collected for a period of 1 year.
|
|
Blood and lymphatic system disorders
DVT
|
2.9%
1/35 • Adverse event data were collected for a period of 1 year.
|
0.00%
0/31 • Adverse event data were collected for a period of 1 year.
|
|
Nervous system disorders
Severe Sciatica
|
2.9%
1/35 • Adverse event data were collected for a period of 1 year.
|
0.00%
0/31 • Adverse event data were collected for a period of 1 year.
|
|
Infections and infestations
Infection in the knee
|
0.00%
0/35 • Adverse event data were collected for a period of 1 year.
|
3.2%
1/31 • Adverse event data were collected for a period of 1 year.
|
|
Infections and infestations
C-Diff infection
|
0.00%
0/35 • Adverse event data were collected for a period of 1 year.
|
3.2%
1/31 • Adverse event data were collected for a period of 1 year.
|
|
Surgical and medical procedures
TKA revision
|
0.00%
0/35 • Adverse event data were collected for a period of 1 year.
|
3.2%
1/31 • Adverse event data were collected for a period of 1 year.
|
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Stevens-Lapsley, PhD
University of Colorado Denver
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place