Trial Outcomes & Findings for Electromyostimulation and Strength Walking for Knee Injuries (NCT NCT02065518)
NCT ID: NCT02065518
Last Updated: 2019-08-28
Results Overview
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
0, 3, 6, 9, 12, and 18 weeks
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Standard Rehabilitation Protocol (SRP)
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
20
|
20
|
|
Overall Study
COMPLETED
|
13
|
11
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
9
|
5
|
Reasons for withdrawal
| Measure |
Standard Rehabilitation Protocol (SRP)
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
9
|
2
|
Baseline Characteristics
Electromyostimulation and Strength Walking for Knee Injuries
Baseline characteristics by cohort
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
35 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
35 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
33 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
34 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · African-American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian/Pacific
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Multi-racial
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 6, 9, 12, and 18 weeksMuscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 0
|
27.5 Kilograms
Standard Deviation 12.4
|
32.6 Kilograms
Standard Deviation 14.7
|
32.1 Kilograms
Standard Deviation 15.5
|
24.3 Kilograms
Standard Deviation 11.4
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 3
|
25.4 Kilograms
Standard Deviation 15.9
|
32 Kilograms
Standard Deviation 10.4
|
30.4 Kilograms
Standard Deviation 10.3
|
27.8 Kilograms
Standard Deviation 13.7
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 6
|
23.3 Kilograms
Standard Deviation 11.5
|
33.7 Kilograms
Standard Deviation 11.5
|
29.8 Kilograms
Standard Deviation 10
|
27.1 Kilograms
Standard Deviation 13.4
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 9
|
26 Kilograms
Standard Deviation 15.1
|
33.9 Kilograms
Standard Deviation 13.6
|
29.2 Kilograms
Standard Deviation 13.7
|
34 Kilograms
Standard Deviation 16.8
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 12
|
27.8 Kilograms
Standard Deviation 16
|
33 Kilograms
Standard Deviation 10.6
|
32.7 Kilograms
Standard Deviation 16.6
|
30.8 Kilograms
Standard Deviation 14.8
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 18
|
28.5 Kilograms
Standard Deviation 17.3
|
36.2 Kilograms
Standard Deviation 10.2
|
31 Kilograms
Standard Deviation 16.6
|
33.5 Kilograms
Standard Deviation 15.8
|
|
Lower Extremity Muscle Strength- Extension
Uninjured Knee: Week 0
|
28.2 Kilograms
Standard Deviation 13
|
37.2 Kilograms
Standard Deviation 16.4
|
36.2 Kilograms
Standard Deviation 21.2
|
27.6 Kilograms
Standard Deviation 14
|
|
Lower Extremity Muscle Strength- Extension
Uninjured Knee: Week 3
|
26 Kilograms
Standard Deviation 15.5
|
38.3 Kilograms
Standard Deviation 18.8
|
34.5 Kilograms
Standard Deviation 14.9
|
28 Kilograms
Standard Deviation 13.8
|
|
Lower Extremity Muscle Strength- Extension
Uninjured Knee: Week 6
|
25.4 Kilograms
Standard Deviation 11.2
|
35.9 Kilograms
Standard Deviation 13.9
|
34.2 Kilograms
Standard Deviation 15.1
|
33.5 Kilograms
Standard Deviation 19.4
|
|
Lower Extremity Muscle Strength- Extension
Uninjured Knee: Week 9
|
27.2 Kilograms
Standard Deviation 14
|
35.9 Kilograms
Standard Deviation 15.1
|
29.8 Kilograms
Standard Deviation 19.9
|
36.2 Kilograms
Standard Deviation 18.3
|
|
Lower Extremity Muscle Strength- Extension
Uninjured Knee: Week 12
|
25.8 Kilograms
Standard Deviation 14.2
|
35.8 Kilograms
Standard Deviation 12.6
|
33.8 Kilograms
Standard Deviation 15.9
|
38.7 Kilograms
Standard Deviation 22.6
|
|
Lower Extremity Muscle Strength- Extension
Uninjured Knee: Week 18
|
27.6 Kilograms
Standard Deviation 12
|
32.3 Kilograms
Standard Deviation 9.1
|
33.2 Kilograms
Standard Deviation 20.3
|
38.6 Kilograms
Standard Deviation 22.1
|
PRIMARY outcome
Timeframe: 0, 3, 6, 9, 12, and 18 weeksMuscle strength was measured with a handheld dynamometer for flexor knee strength of the injured and uninjured knee.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 0
|
16.2 Kilograms
Standard Deviation 9.4
|
16.6 Kilograms
Standard Deviation 7
|
16.2 Kilograms
Standard Deviation 8.6
|
13.7 Kilograms
Standard Deviation 6.9
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 3
|
15.3 Kilograms
Standard Deviation 8.3
|
16.9 Kilograms
Standard Deviation 4.8
|
17.8 Kilograms
Standard Deviation 5.5
|
14.9 Kilograms
Standard Deviation 7.4
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 12
|
14.5 Kilograms
Standard Deviation 7.3
|
16.5 Kilograms
Standard Deviation 4.5
|
18.4 Kilograms
Standard Deviation 5.7
|
17.3 Kilograms
Standard Deviation 7.4
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 18
|
14.7 Kilograms
Standard Deviation 7.8
|
17.4 Kilograms
Standard Deviation 4
|
15.4 Kilograms
Standard Deviation 5.5
|
19.3 Kilograms
Standard Deviation 10.4
|
|
Lower Extremity Muscle Strength- Flexion
Uninjured Knee: Week 0
|
20 Kilograms
Standard Deviation 6.7
|
22.5 Kilograms
Standard Deviation 8.4
|
22.6 Kilograms
Standard Deviation 8
|
19.8 Kilograms
Standard Deviation 8.6
|
|
Lower Extremity Muscle Strength- Flexion
Uninjured Knee: Week 3
|
20.1 Kilograms
Standard Deviation 7.9
|
23.5 Kilograms
Standard Deviation 8.2
|
22.7 Kilograms
Standard Deviation 7.4
|
20.2 Kilograms
Standard Deviation 7.5
|
|
Lower Extremity Muscle Strength- Flexion
Uninjured Knee: Week 18
|
18.1 Kilograms
Standard Deviation 6.8
|
23.1 Kilograms
Standard Deviation 8.2
|
24.1 Kilograms
Standard Deviation 12
|
24.2 Kilograms
Standard Deviation 11.3
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 6
|
15.4 Kilograms
Standard Deviation 9.9
|
21.3 Kilograms
Standard Deviation 12.1
|
15 Kilograms
Standard Deviation 4.5
|
14.8 Kilograms
Standard Deviation 5.9
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 9
|
15.6 Kilograms
Standard Deviation 12.6
|
15.3 Kilograms
Standard Deviation 4.9
|
15.9 Kilograms
Standard Deviation 5.6
|
16.6 Kilograms
Standard Deviation 7.2
|
|
Lower Extremity Muscle Strength- Flexion
Uninjured Knee: Week 6
|
16.9 Kilograms
Standard Deviation 7.2
|
22.9 Kilograms
Standard Deviation 6.6
|
19.8 Kilograms
Standard Deviation 6.4
|
19.9 Kilograms
Standard Deviation 10.3
|
|
Lower Extremity Muscle Strength- Flexion
Uninjured Knee: Week 9
|
17.5 Kilograms
Standard Deviation 12.6
|
20.8 Kilograms
Standard Deviation 5.2
|
23 Kilograms
Standard Deviation 10.4
|
27.4 Kilograms
Standard Deviation 15.7
|
|
Lower Extremity Muscle Strength- Flexion
Uninjured Knee: Week 12
|
17.3 Kilograms
Standard Deviation 8.4
|
22.7 Kilograms
Standard Deviation 6.4
|
25.9 Kilograms
Standard Deviation 12.2
|
23 Kilograms
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: 0, 6, 12, and 18 weeksMobility was measured by the distance walked at a fast pace over 6-minutes,
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 0
|
19800 Inches
Standard Deviation 3398
|
20224 Inches
Standard Deviation 5162
|
19728 Inches
Standard Deviation 5347
|
18974 Inches
Standard Deviation 4603
|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 6
|
21822 Inches
Standard Deviation 4346
|
21696 Inches
Standard Deviation 3905
|
22197 Inches
Standard Deviation 3242
|
21696 Inches
Standard Deviation 3905
|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 12
|
21404 Inches
Standard Deviation 2534
|
22210 Inches
Standard Deviation 3991
|
21595 Inches
Standard Deviation 3092
|
20824 Inches
Standard Deviation 6223
|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 18
|
21210 Inches
Standard Deviation 3718
|
22984 Inches
Standard Deviation 3390
|
22105 Inches
Standard Deviation 3718
|
22945 Inches
Standard Deviation 2883
|
PRIMARY outcome
Timeframe: 0, 6, 12, and 18 weeksMobility was measured by the number of complete standing and sitting cycles in 30-seconds
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Lower Extremity Strength- Chair Test
Week 0
|
11.3 Rises
Standard Deviation 3.7
|
11.4 Rises
Standard Deviation 1.8
|
12.7 Rises
Standard Deviation 3.9
|
10.7 Rises
Standard Deviation 2.8
|
|
Lower Extremity Strength- Chair Test
Week 6
|
12.7 Rises
Standard Deviation 3.8
|
13.6 Rises
Standard Deviation 2.6
|
14.4 Rises
Standard Deviation 4
|
13.2 Rises
Standard Deviation 1.9
|
|
Lower Extremity Strength- Chair Test
Week 12
|
13.3 Rises
Standard Deviation 4.8
|
13.9 Rises
Standard Deviation 2.3
|
14.4 Rises
Standard Deviation 2.3
|
14.5 Rises
Standard Deviation 2.1
|
|
Lower Extremity Strength- Chair Test
Week 18
|
13.3 Rises
Standard Deviation 3.7
|
14.4 Rises
Standard Deviation 1.5
|
15 Rises
Standard Deviation 2.7
|
15.2 Rises
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 0, 6, 12, and 18 weeksMobility and endurance were measured by the number of up and down step cycles completed in 2-minutes.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Lower Extremity Mobility and Endurance- Step Test
Week 0
|
189 Step Cycles
Standard Deviation 67
|
162 Step Cycles
Standard Deviation 62
|
199 Step Cycles
Standard Deviation 60
|
172 Step Cycles
Standard Deviation 67
|
|
Lower Extremity Mobility and Endurance- Step Test
Week 6
|
185 Step Cycles
Standard Deviation 76
|
178 Step Cycles
Standard Deviation 78
|
224 Step Cycles
Standard Deviation 64
|
205 Step Cycles
Standard Deviation 75
|
|
Lower Extremity Mobility and Endurance- Step Test
Week 12
|
180 Step Cycles
Standard Deviation 82
|
235 Step Cycles
Standard Deviation 46
|
258 Step Cycles
Standard Deviation 42
|
202 Step Cycles
Standard Deviation 73
|
|
Lower Extremity Mobility and Endurance- Step Test
Week 18
|
202 Step Cycles
Standard Deviation 92
|
233 Step Cycles
Standard Deviation 75
|
224 Step Cycles
Standard Deviation 56
|
216 Step Cycles
Standard Deviation 73
|
SECONDARY outcome
Timeframe: 0, 3, 6, 9, 12, and 18 weeksPain severity was measured using item 3 from the IDKC Subjective Knee Evaluation: "If you have knee pain, how severe is it?" Participants responded using a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Overall Pain Severity
Week 0
|
5.4 score on a scale
Standard Deviation 1.9
|
4.9 score on a scale
Standard Deviation 2.1
|
5.7 score on a scale
Standard Deviation 1.7
|
5.1 score on a scale
Standard Deviation 1.9
|
|
Overall Pain Severity
Week 6
|
6.2 score on a scale
Standard Deviation 2.5
|
3.8 score on a scale
Standard Deviation 1.6
|
5.3 score on a scale
Standard Deviation 2.5
|
5.0 score on a scale
Standard Deviation 2.3
|
|
Overall Pain Severity
Week 9
|
5.8 score on a scale
Standard Deviation 2.4
|
4.1 score on a scale
Standard Deviation 1.9
|
4.4 score on a scale
Standard Deviation 1.7
|
4.3 score on a scale
Standard Deviation 2.4
|
|
Overall Pain Severity
Week 12
|
5.3 score on a scale
Standard Deviation 2.6
|
4.2 score on a scale
Standard Deviation 2.1
|
5.1 score on a scale
Standard Deviation 2.7
|
4.5 score on a scale
Standard Deviation 2
|
|
Overall Pain Severity
Week 18
|
4.7 score on a scale
Standard Deviation 3.1
|
3.6 score on a scale
Standard Deviation 2.4
|
4.3 score on a scale
Standard Deviation 2.4
|
3.9 score on a scale
Standard Deviation 2.3
|
|
Overall Pain Severity
Week 3
|
5.9 score on a scale
Standard Deviation 2.3
|
5 score on a scale
Standard Deviation 2.3
|
5.4 score on a scale
Standard Deviation 1.9
|
5.0 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 0, 6, 12, and 18 weeksKnee pain intensity after the 6-Minute Walk Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 0
|
2.4 score on a scale
Standard Deviation 2.2
|
2.9 score on a scale
Standard Deviation 2.4
|
1.8 score on a scale
Standard Deviation 2.1
|
2.5 score on a scale
Standard Deviation 2.1
|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 6
|
3.2 score on a scale
Standard Deviation 2.5
|
1.6 score on a scale
Standard Deviation 1.9
|
1.7 score on a scale
Standard Deviation 2.8
|
1.4 score on a scale
Standard Deviation 1.2
|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 12
|
2.7 score on a scale
Standard Deviation 2.1
|
1.9 score on a scale
Standard Deviation 2.1
|
1.6 score on a scale
Standard Deviation 2.0
|
1.6 score on a scale
Standard Deviation 1.7
|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 18
|
2.3 score on a scale
Standard Deviation 2.1
|
1.6 score on a scale
Standard Deviation 2.2
|
2.1 score on a scale
Standard Deviation 2.9
|
1.2 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 0, 6, 12, and 18 weeksKnee pain intensity after the 30-Second Chair Stand Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Knee Pain Following Performance Testing- Chair Stand Test
Week 0
|
3.7 score on a scale
Standard Deviation 2.3
|
2.5 score on a scale
Standard Deviation 2.4
|
2.1 score on a scale
Standard Deviation 1.9
|
2.7 score on a scale
Standard Deviation 1.4
|
|
Knee Pain Following Performance Testing- Chair Stand Test
Week 6
|
3.5 score on a scale
Standard Deviation 2.6
|
1.4 score on a scale
Standard Deviation 1.8
|
1.4 score on a scale
Standard Deviation 2.0
|
1.2 score on a scale
Standard Deviation 1.4
|
|
Knee Pain Following Performance Testing- Chair Stand Test
Week 12
|
2.8 score on a scale
Standard Deviation 2.2
|
2.0 score on a scale
Standard Deviation 2.6
|
1.7 score on a scale
Standard Deviation 2.5
|
1.2 score on a scale
Standard Deviation 1.5
|
|
Knee Pain Following Performance Testing- Chair Stand Test
Week 18
|
2.4 score on a scale
Standard Deviation 2.0
|
0.7 score on a scale
Standard Deviation 0.9
|
1.5 score on a scale
Standard Deviation 2.2
|
0.8 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 0, 6, 12, and 18 weeksKnee pain intensity after the 2-Minute Step Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Knee Pain Following Performance Testing- 2-Minute Step Test
Week 0
|
4.0 score on a scale
Standard Deviation 2.4
|
3.7 score on a scale
Standard Deviation 2.7
|
3.0 score on a scale
Standard Deviation 2.1
|
3.7 score on a scale
Standard Deviation 2.4
|
|
Knee Pain Following Performance Testing- 2-Minute Step Test
Week 6
|
3.5 score on a scale
Standard Deviation 2.8
|
2.1 score on a scale
Standard Deviation 2.5
|
2.5 score on a scale
Standard Deviation 2.5
|
2.4 score on a scale
Standard Deviation 1.4
|
|
Knee Pain Following Performance Testing- 2-Minute Step Test
Week 12
|
2.9 score on a scale
Standard Deviation 2.6
|
3.0 score on a scale
Standard Deviation 2.4
|
3.0 score on a scale
Standard Deviation 2.4
|
1.9 score on a scale
Standard Deviation 2.3
|
|
Knee Pain Following Performance Testing- 2-Minute Step Test
Week 18
|
2.6 score on a scale
Standard Deviation 2.4
|
1.7 score on a scale
Standard Deviation 2.4
|
2.1 score on a scale
Standard Deviation 2.7
|
1.8 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 0, 3, 6, 9, 12, and 18 weeksThe Activities of Daily Living Scale was used to measure self-perceived knee symptoms while performing typical activities. The knee symptom subscale ranges from "I do not have the symptom" to "The symptom prevents me from all daily activity". Scores ranged from 0-35. Higher scores are associated with diminished symptoms. A mean score was calculated.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Activities of Daily Living- Knee Symptoms
Week 0
|
25.4 score on a scale
Standard Deviation 4.7
|
23.3 score on a scale
Standard Deviation 6.3
|
25.1 score on a scale
Standard Deviation 5.2
|
22.9 score on a scale
Standard Deviation 4.3
|
|
Activities of Daily Living- Knee Symptoms
Week 3
|
25.0 score on a scale
Standard Deviation 5.5
|
24.6 score on a scale
Standard Deviation 6.9
|
26.2 score on a scale
Standard Deviation 6.0
|
26 score on a scale
Standard Deviation 2.8
|
|
Activities of Daily Living- Knee Symptoms
Week 9
|
25 score on a scale
Standard Deviation 6.1
|
29.3 score on a scale
Standard Deviation 6.6
|
29.6 score on a scale
Standard Deviation 4.1
|
27.2 score on a scale
Standard Deviation 4.7
|
|
Activities of Daily Living- Knee Symptoms
Week 12
|
27.8 score on a scale
Standard Deviation 6.3
|
26.5 score on a scale
Standard Deviation 7.6
|
30.8 score on a scale
Standard Deviation 3
|
27.6 score on a scale
Standard Deviation 4.8
|
|
Activities of Daily Living- Knee Symptoms
Week 18
|
29.6 score on a scale
Standard Deviation 5.2
|
29.7 score on a scale
Standard Deviation 4.7
|
30.9 score on a scale
Standard Deviation 4.3
|
29.8 score on a scale
Standard Deviation 4.7
|
|
Activities of Daily Living- Knee Symptoms
Week 6
|
24.4 score on a scale
Standard Deviation 6.5
|
27.9 score on a scale
Standard Deviation 6.4
|
28.1 score on a scale
Standard Deviation 4.7
|
27.4 score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: 0, 3, 6, 9, 12, and 18 weeksThe Activities of Daily Living Scale was used to measure self-perceived limitations while performing typical activities. The limitation subscale ranges from "Activity is not difficult " to "I am unable to do the activity". Scores range from 0-45. Higher scores are associated with diminished symptoms. A mean score was calculated.
Outcome measures
| Measure |
Standard Rehabilitation Protocol (SRP)
n=19 Participants
Standard Rehabilitation Protocol: All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
|
NMES w/ SRP
n=19 Participants
NMES (EMPI 300PV stimulator) plus SRP: NMES training consisted of four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session entails 15 minutes/leg with 15 contractions per leg.
Weeks 1-3: 15-20% of maximal voluntary contraction (MVC); Weeks 3-6: 20-30% of MVC; Weeks 6-9: 30-40% of MVC; Weeks 9-12: 40-50% of MVC; Weeks 12-18: sustain 50% of MVC. Incremental increases made at the 3, 6, 9, and 12-week clinic visits.
|
Strength Walking w/ SRP
n=20 Participants
Home-Based Pedometer-Driven Walking Program plus SRP: Participants were given a pedometer to monitor daily steps and a weighted exercise vest at Week 7 to begin the strengthening component. A series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool.
Participants maintain a daily training log. Pedometer readings used for setting activity goals. Initial step goals: 10% above the average 3-day pedometer step count at baseline. A 10% increase every other week, then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a vest to begin the strengthening component. The beginning weight load for the vest is calculated using 2% of baseline body weight and increased by the same amount every week until the end of the 12 weeks.
|
NMES/Strength Walking w/ SRP
n=20 Participants
NMES, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
|
|---|---|---|---|---|
|
Activities of Daily Living- Activity Limitation
Week 0
|
32.9 score on a scale
Standard Deviation 6.1
|
30.9 score on a scale
Standard Deviation 4.9
|
30.9 score on a scale
Standard Deviation 7.2
|
31.5 score on a scale
Standard Deviation 2.4
|
|
Activities of Daily Living- Activity Limitation
Week 3
|
33.4 score on a scale
Standard Deviation 6.4
|
33.3 score on a scale
Standard Deviation 5.2
|
34.8 score on a scale
Standard Deviation 5.8
|
33 score on a scale
Standard Deviation 3.0
|
|
Activities of Daily Living- Activity Limitation
Week 6
|
33.5 score on a scale
Standard Deviation 8.1
|
35.5 score on a scale
Standard Deviation 5.5
|
34.9 score on a scale
Standard Deviation 6.1
|
35.6 score on a scale
Standard Deviation 4.4
|
|
Activities of Daily Living- Activity Limitation
Week 9
|
31.8 score on a scale
Standard Deviation 6.9
|
39.8 score on a scale
Standard Deviation 4.1
|
35.3 score on a scale
Standard Deviation 5.8
|
36.5 score on a scale
Standard Deviation 4.4
|
|
Activities of Daily Living- Activity Limitation
Week 12
|
32.9 score on a scale
Standard Deviation 7.7
|
35.7 score on a scale
Standard Deviation 5.9
|
36.7 score on a scale
Standard Deviation 5.1
|
36.6 score on a scale
Standard Deviation 5.4
|
|
Activities of Daily Living- Activity Limitation
Week 18
|
36.4 score on a scale
Standard Deviation 6.7
|
38.1 score on a scale
Standard Deviation 4.9
|
36.9 score on a scale
Standard Deviation 6.0
|
38.6 score on a scale
Standard Deviation 5.6
|
Adverse Events
Standard Rehabilitation Protocol (SRP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NMES w/ SRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Strength Walking w/ SRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NMES/Strength Walking w/ SRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Laura Talbot
University of Tennessee Health Science Center
Phone: 901-448-3630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place