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Trial record 50 of 10351 for:    strength

Electromyostimulation and Strength Walking for Knee Injuries (KI)

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ClinicalTrials.gov Identifier: NCT02065518
Recruitment Status : Completed
First Posted : February 19, 2014
Results First Posted : August 14, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Malcolm Grow Medical Clinics and Surgery Center
Information provided by (Responsible Party):
University of Tennessee

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Knee Injury
Interventions Device: NMES
Behavioral: Strength Walking
Behavioral: Standard Rehabilitation Protocol
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description 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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Period Title: Overall Study
Started 19 19 20 20
Completed 13 11 11 15
Not Completed 6 8 9 5
Reason Not Completed
Lost to Follow-up             3             4             0             3
Withdrawal by Subject             3             4             9             2
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP Total
Hide Arm/Group Description 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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking. Total of all reporting groups
Overall Number of Baseline Participants 19 19 20 20 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 20 participants 20 participants 78 participants
33  (8.4) 35  (7.9) 35  (11.3) 33  (6.1) 34  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 20 participants 20 participants 78 participants
Female
10
  52.6%
10
  52.6%
11
  55.0%
11
  55.0%
42
  53.8%
Male
9
  47.4%
9
  47.4%
9
  45.0%
9
  45.0%
36
  46.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 19 participants 19 participants 20 participants 20 participants 78 participants
Caucasian
8
  42.1%
11
  57.9%
8
  40.0%
13
  65.0%
40
  51.3%
African-American
8
  42.1%
6
  31.6%
7
  35.0%
5
  25.0%
26
  33.3%
Asian/Pacific
0
   0.0%
0
   0.0%
2
  10.0%
1
   5.0%
3
   3.8%
Multi-racial
3
  15.8%
1
   5.3%
2
  10.0%
1
   5.0%
7
   9.0%
Missing
0
   0.0%
1
   5.3%
1
   5.0%
0
   0.0%
2
   2.6%
1.Primary Outcome
Title Lower Extremity Muscle Strength- Extension
Hide Description Muscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee.
Time Frame 0, 3, 6, 9, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: Kilograms
Injured Knee: Week 0 27.5  (12.4) 32.6  (14.7) 32.1  (15.5) 24.3  (11.4)
Injured Knee: Week 3 25.4  (15.9) 32  (10.4) 30.4  (10.3) 27.8  (13.7)
Injured Knee: Week 6 23.3  (11.5) 33.7  (11.5) 29.8  (10) 27.1  (13.4)
Injured Knee: Week 9 26  (15.1) 33.9  (13.6) 29.2  (13.7) 34  (16.8)
Injured Knee: Week 12 27.8  (16) 33  (10.6) 32.7  (16.6) 30.8  (14.8)
Injured Knee: Week 18 28.5  (17.3) 36.2  (10.2) 31  (16.6) 33.5  (15.8)
Uninjured Knee: Week 0 28.2  (13) 37.2  (16.4) 36.2  (21.2) 27.6  (14)
Uninjured Knee: Week 3 26  (15.5) 38.3  (18.8) 34.5  (14.9) 28  (13.8)
Uninjured Knee: Week 6 25.4  (11.2) 35.9  (13.9) 34.2  (15.1) 33.5  (19.4)
Uninjured Knee: Week 9 27.2  (14) 35.9  (15.1) 29.8  (19.9) 36.2  (18.3)
Uninjured Knee: Week 12 25.8  (14.2) 35.8  (12.6) 33.8  (15.9) 38.7  (22.6)
Uninjured Knee: Week 18 27.6  (12) 32.3  (9.1) 33.2  (20.3) 38.6  (22.1)
2.Primary Outcome
Title Lower Extremity Muscle Strength- Flexion
Hide Description Muscle strength was measured with a handheld dynamometer for flexor knee strength of the injured and uninjured knee.
Time Frame 0, 3, 6, 9, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: Kilograms
Injured Knee: Week 0 16.2  (9.4) 16.6  (7) 16.2  (8.6) 13.7  (6.9)
Injured Knee: Week 3 15.3  (8.3) 16.9  (4.8) 17.8  (5.5) 14.9  (7.4)
Injured Knee: Week 6 15.4  (9.9) 21.3  (12.1) 15  (4.5) 14.8  (5.9)
Injured Knee: Week 9 15.6  (12.6) 15.3  (4.9) 15.9  (5.6) 16.6  (7.2)
Injured Knee: Week 12 14.5  (7.3) 16.5  (4.5) 18.4  (5.7) 17.3  (7.4)
Injured Knee: Week 18 14.7  (7.8) 17.4  (4) 15.4  (5.5) 19.3  (10.4)
Uninjured Knee: Week 0 20  (6.7) 22.5  (8.4) 22.6  (8) 19.8  (8.6)
Uninjured Knee: Week 3 20.1  (7.9) 23.5  (8.2) 22.7  (7.4) 20.2  (7.5)
Uninjured Knee: Week 6 16.9  (7.2) 22.9  (6.6) 19.8  (6.4) 19.9  (10.3)
Uninjured Knee: Week 9 17.5  (12.6) 20.8  (5.2) 23  (10.4) 27.4  (15.7)
Uninjured Knee: Week 12 17.3  (8.4) 22.7  (6.4) 25.9  (12.2) 23  (11.1)
Uninjured Knee: Week 18 18.1  (6.8) 23.1  (8.2) 24.1  (12) 24.2  (11.3)
3.Primary Outcome
Title Lower Extremity Mobility- 6-Minute Walk Test
Hide Description Mobility was measured by the distance walked at a fast pace over 6-minutes,
Time Frame 0, 6, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: Inches
Week 0 19800  (3398) 20224  (5162) 19728  (5347) 18974  (4603)
Week 6 21822  (4346) 21696  (3905) 22197  (3242) 21696  (3905)
Week 12 21404  (2534) 22210  (3991) 21595  (3092) 20824  (6223)
Week 18 21210  (3718) 22984  (3390) 22105  (3718) 22945  (2883)
4.Primary Outcome
Title Lower Extremity Strength- Chair Test
Hide Description Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
Time Frame 0, 6, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: Rises
Week 0 11.3  (3.7) 11.4  (1.8) 12.7  (3.9) 10.7  (2.8)
Week 6 12.7  (3.8) 13.6  (2.6) 14.4  (4) 13.2  (1.9)
Week 12 13.3  (4.8) 13.9  (2.3) 14.4  (2.3) 14.5  (2.1)
Week 18 13.3  (3.7) 14.4  (1.5) 15  (2.7) 15.2  (2.2)
5.Primary Outcome
Title Lower Extremity Mobility and Endurance- Step Test
Hide Description Mobility and endurance were measured by the number of up and down step cycles completed in 2-minutes.
Time Frame 0, 6, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: Step Cycles
Week 0 189  (67) 162  (62) 199  (60) 172  (67)
Week 6 185  (76) 178  (78) 224  (64) 205  (75)
Week 12 180  (82) 235  (46) 258  (42) 202  (73)
Week 18 202  (92) 233  (75) 224  (56) 216  (73)
6.Secondary Outcome
Title Overall Pain Severity
Hide Description Pain 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.
Time Frame 0, 3, 6, 9, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 0 5.4  (1.9) 4.9  (2.1) 5.7  (1.7) 5.1  (1.9)
Week 3 5.9  (2.3) 5  (2.3) 5.4  (1.9) 5.0  (1.8)
Week 6 6.2  (2.5) 3.8  (1.6) 5.3  (2.5) 5.0  (2.3)
Week 9 5.8  (2.4) 4.1  (1.9) 4.4  (1.7) 4.3  (2.4)
Week 12 5.3  (2.6) 4.2  (2.1) 5.1  (2.7) 4.5  (2)
Week 18 4.7  (3.1) 3.6  (2.4) 4.3  (2.4) 3.9  (2.3)
7.Secondary Outcome
Title Knee Pain Following Performance Testing- 6-Minute Walk Test
Hide Description Knee 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.
Time Frame 0, 6, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 0 2.4  (2.2) 2.9  (2.4) 1.8  (2.1) 2.5  (2.1)
Week 6 3.2  (2.5) 1.6  (1.9) 1.7  (2.8) 1.4  (1.2)
Week 12 2.7  (2.1) 1.9  (2.1) 1.6  (2.0) 1.6  (1.7)
Week 18 2.3  (2.1) 1.6  (2.2) 2.1  (2.9) 1.2  (2.1)
8.Secondary Outcome
Title Knee Pain Following Performance Testing- Chair Stand Test
Hide Description Knee 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.
Time Frame 0, 6, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 0 3.7  (2.3) 2.5  (2.4) 2.1  (1.9) 2.7  (1.4)
Week 6 3.5  (2.6) 1.4  (1.8) 1.4  (2.0) 1.2  (1.4)
Week 12 2.8  (2.2) 2.0  (2.6) 1.7  (2.5) 1.2  (1.5)
Week 18 2.4  (2.0) 0.7  (0.9) 1.5  (2.2) 0.8  (1.5)
9.Secondary Outcome
Title Knee Pain Following Performance Testing- 2-Minute Step Test
Hide Description Knee 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.
Time Frame 0, 6, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 0 4.0  (2.4) 3.7  (2.7) 3.0  (2.1) 3.7  (2.4)
Week 6 3.5  (2.8) 2.1  (2.5) 2.5  (2.5) 2.4  (1.4)
Week 12 2.9  (2.6) 3.0  (2.4) 3.0  (2.4) 1.9  (2.3)
Week 18 2.6  (2.4) 1.7  (2.4) 2.1  (2.7) 1.8  (2.6)
10.Secondary Outcome
Title Activities of Daily Living- Knee Symptoms
Hide Description The 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.
Time Frame 0, 3, 6, 9, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 0 25.4  (4.7) 23.3  (6.3) 25.1  (5.2) 22.9  (4.3)
Week 3 25.0  (5.5) 24.6  (6.9) 26.2  (6.0) 26  (2.8)
Week 6 24.4  (6.5) 27.9  (6.4) 28.1  (4.7) 27.4  (4.0)
Week 9 25  (6.1) 29.3  (6.6) 29.6  (4.1) 27.2  (4.7)
Week 12 27.8  (6.3) 26.5  (7.6) 30.8  (3) 27.6  (4.8)
Week 18 29.6  (5.2) 29.7  (4.7) 30.9  (4.3) 29.8  (4.7)
11.Secondary Outcome
Title Activities of Daily Living- Activity Limitation
Hide Description The 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.
Time Frame 0, 3, 6, 9, 12, and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description:
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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
Overall Number of Participants Analyzed 19 19 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 0 32.9  (6.1) 30.9  (4.9) 30.9  (7.2) 31.5  (2.4)
Week 3 33.4  (6.4) 33.3  (5.2) 34.8  (5.8) 33  (3.0)
Week 6 33.5  (8.1) 35.5  (5.5) 34.9  (6.1) 35.6  (4.4)
Week 9 31.8  (6.9) 39.8  (4.1) 35.3  (5.8) 36.5  (4.4)
Week 12 32.9  (7.7) 35.7  (5.9) 36.7  (5.1) 36.6  (5.4)
Week 18 36.4  (6.7) 38.1  (4.9) 36.9  (6.0) 38.6  (5.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Hide Arm/Group Description 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 (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.

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, Home-Based Pedometer-Driven Walking Program plus SRP: This group will follow the protocol for both the NMES training and Strength Walking.
All-Cause Mortality
Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Rehabilitation Protocol (SRP) NMES w/ SRP Strength Walking w/ SRP NMES/Strength Walking w/ SRP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Laura Talbot
Organization: University of Tennessee Health Science Center
Phone: 901-448-3630
EMail: ltalbot@uthsc.edu
Other Publications:
Talbot LA. (2016). Electromyostimulation and Strength Walking for Knee Injuries: Nurse Managed Care. 19 p, NTIS Report No.: PB2017102173.
Layout table for additonal information
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02065518     History of Changes
Other Study ID Numbers: HU0001-10-1-TS04
TSNRP Grant HU0001-10-1-TS04 ( Other Grant/Funding Number: TSNRP )
First Submitted: February 12, 2014
First Posted: February 19, 2014
Results First Submitted: July 23, 2019
Results First Posted: August 14, 2019
Last Update Posted: August 27, 2019