Trial Outcomes & Findings for Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty (NCT NCT02597673)
NCT ID: NCT02597673
Last Updated: 2020-10-01
Results Overview
The NMMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. The measurement of KE strength on the PFPS leg is reported. For each test, participants performed three maximal efforts holding each contraction for 4 seconds, separated by 30-second rest; the highest value of the three trials will be accepted in kilograms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
0, 3, 6, and 9 weeks
Results posted on
2020-10-01
Participant Flow
2 participants withdrew from the study during baseline testing, and prior to being assigned to a group.
Participant milestones
| Measure |
Standard Rehabilitation Protocol
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed TENS Program
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
33
|
30
|
|
Overall Study
COMPLETED
|
31
|
27
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
Baseline characteristics by cohort
| Measure |
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
33 participants
n=5 Participants
|
30 participants
n=4 Participants
|
130 participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Height
|
176 cm
STANDARD_DEVIATION 11.2 • n=5 Participants
|
174 cm
STANDARD_DEVIATION 10.8 • n=7 Participants
|
177 cm
STANDARD_DEVIATION 8.1 • n=5 Participants
|
175 cm
STANDARD_DEVIATION 7.37 • n=4 Participants
|
176 cm
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Weight
|
86 kg
STANDARD_DEVIATION 16.7 • n=5 Participants
|
85 kg
STANDARD_DEVIATION 16.1 • n=7 Participants
|
86 kg
STANDARD_DEVIATION 14.4 • n=5 Participants
|
84 kg
STANDARD_DEVIATION 14.8 • n=4 Participants
|
85.3 kg
STANDARD_DEVIATION 15.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 6, and 9 weeksThe NMMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. The measurement of KE strength on the PFPS leg is reported. For each test, participants performed three maximal efforts holding each contraction for 4 seconds, separated by 30-second rest; the highest value of the three trials will be accepted in kilograms.
Outcome measures
| Measure |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Lower Extremity Muscle Strength- Extension
Unaffected Knee: Week 0
|
43.75 Kg-Force
Standard Deviation 17.33
|
45.07 Kg-Force
Standard Deviation 17.83
|
44.56 Kg-Force
Standard Deviation 18.75
|
45.42 Kg-Force
Standard Deviation 18.67
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 0
|
37.14 Kg-Force
Standard Deviation 15.36
|
41.58 Kg-Force
Standard Deviation 16.56
|
37.74 Kg-Force
Standard Deviation 15.39
|
40.42 Kg-Force
Standard Deviation 18.87
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 3
|
43.21 Kg-Force
Standard Deviation 21.49
|
41.41 Kg-Force
Standard Deviation 14.92
|
42.70 Kg-Force
Standard Deviation 18.66
|
43.07 Kg-Force
Standard Deviation 17.80
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 6
|
41.67 Kg-Force
Standard Deviation 20.60
|
44.35 Kg-Force
Standard Deviation 12.40
|
43.31 Kg-Force
Standard Deviation 17.52
|
43.03 Kg-Force
Standard Deviation 16.54
|
|
Lower Extremity Muscle Strength- Extension
Injured Knee: Week 9
|
45.44 Kg-Force
Standard Deviation 23.16
|
41.78 Kg-Force
Standard Deviation 13.46
|
46.22 Kg-Force
Standard Deviation 18.31
|
46.89 Kg-Force
Standard Deviation 17.78
|
|
Lower Extremity Muscle Strength- Extension
Unaffected Knee: Week 3
|
46.64 Kg-Force
Standard Deviation 18.58
|
42.81 Kg-Force
Standard Deviation 15.79
|
47.16 Kg-Force
Standard Deviation 19.24
|
44.61 Kg-Force
Standard Deviation 18.60
|
|
Lower Extremity Muscle Strength- Extension
Unaffected Knee: Week 6
|
46.31 Kg-Force
Standard Deviation 16.60
|
42.74 Kg-Force
Standard Deviation 14.50
|
47.58 Kg-Force
Standard Deviation 18.51
|
46.14 Kg-Force
Standard Deviation 15.84
|
|
Lower Extremity Muscle Strength- Extension
Unaffected Knee: Week 9
|
46.69 Kg-Force
Standard Deviation 18.93
|
43.83 Kg-Force
Standard Deviation 14.72
|
47.87 Kg-Force
Standard Deviation 20.64
|
50.62 Kg-Force
Standard Deviation 18.32
|
PRIMARY outcome
Timeframe: 0, 3, 6, and 9 weeksThe NMMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. The measurement of KE strength on the PFPS leg is reported. For each test, participants performed three maximal efforts holding each contraction for 4 seconds, separated by 30-second rest; the highest value of the three trials will be accepted in kilograms.
Outcome measures
| Measure |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 0
|
21.33 Kg-Force
Standard Deviation 7.13
|
21.85 Kg-Force
Standard Deviation 7.61
|
20.32 Kg-Force
Standard Deviation 7.35
|
21.95 Kg-Force
Standard Deviation 9.13
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 3
|
22.99 Kg-Force
Standard Deviation 8.04
|
22.07 Kg-Force
Standard Deviation 8.05
|
22.49 Kg-Force
Standard Deviation 8.76
|
22.56 Kg-Force
Standard Deviation 8.84
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 6
|
22.43 Kg-Force
Standard Deviation 8.76
|
22.84 Kg-Force
Standard Deviation 7.36
|
23.72 Kg-Force
Standard Deviation 7.35
|
23.86 Kg-Force
Standard Deviation 8.47
|
|
Lower Extremity Muscle Strength- Flexion
Injured Knee: Week 9
|
25.01 Kg-Force
Standard Deviation 9.11
|
24.15 Kg-Force
Standard Deviation 9.67
|
26.95 Kg-Force
Standard Deviation 8.17
|
26.64 Kg-Force
Standard Deviation 10.02
|
|
Lower Extremity Muscle Strength- Flexion
Unaffected Knee: Week 0
|
24.34 Kg-Force
Standard Deviation 7.50
|
23.89 Kg-Force
Standard Deviation 7.20
|
23.11 Kg-Force
Standard Deviation 7.30
|
25.20 Kg-Force
Standard Deviation 8.67
|
|
Lower Extremity Muscle Strength- Flexion
Unaffected Knee: Week 3
|
23.93 Kg-Force
Standard Deviation 7.95
|
24.71 Kg-Force
Standard Deviation 8.58
|
24.93 Kg-Force
Standard Deviation 8.49
|
24.40 Kg-Force
Standard Deviation 8.43
|
|
Lower Extremity Muscle Strength- Flexion
Unaffected Knee: Week 6
|
23.65 Kg-Force
Standard Deviation 8.61
|
25.13 Kg-Force
Standard Deviation 8.80
|
24.64 Kg-Force
Standard Deviation 7.53
|
25.20 Kg-Force
Standard Deviation 7.79
|
|
Lower Extremity Muscle Strength- Flexion
Unaffected Knee: Week 9
|
25.30 Kg-Force
Standard Deviation 8.30
|
24.54 Kg-Force
Standard Deviation 8.27
|
26.21 Kg-Force
Standard Deviation 8.16
|
26.96 Kg-Force
Standard Deviation 8.53
|
PRIMARY outcome
Timeframe: 0, 3, 6, and 9 weeksMobility was measured by the number of complete standing and sitting cycles in 30-seconds
Outcome measures
| Measure |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Lower Extremity Strength- 30-Second Chair Stand Test
Week 0
|
11.0 rises
Standard Deviation 3.1
|
11.6 rises
Standard Deviation 2.8
|
11.0 rises
Standard Deviation 3.0
|
11.0 rises
Standard Deviation 3.8
|
|
Lower Extremity Strength- 30-Second Chair Stand Test
Week 3
|
11.7 rises
Standard Deviation 3.0
|
13.2 rises
Standard Deviation 3.5
|
12.3 rises
Standard Deviation 4.0
|
12.6 rises
Standard Deviation 4.1
|
|
Lower Extremity Strength- 30-Second Chair Stand Test
Week 6
|
13.0 rises
Standard Deviation 2.9
|
14.2 rises
Standard Deviation 3.4
|
12.8 rises
Standard Deviation 4.4
|
13.6 rises
Standard Deviation 3.9
|
|
Lower Extremity Strength- 30-Second Chair Stand Test
Week 9
|
13.4 rises
Standard Deviation 3.5
|
15.3 rises
Standard Deviation 4.0
|
14.4 rises
Standard Deviation 4.4
|
15.1 rises
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: 0, 3, 6, and 9 weeksStrength, balance, and power were measured by the number seconds it took to ascend and descend 4 steps (6 in rise, 11.5 in run).
Outcome measures
| Measure |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Lower Extremity Strength- Timed Stair Climb Test
Week 0
|
4.2 Seconds
Standard Deviation 1.4
|
3.7 Seconds
Standard Deviation 1.1
|
4.0 Seconds
Standard Deviation 1.4
|
4.1 Seconds
Standard Deviation 1.6
|
|
Lower Extremity Strength- Timed Stair Climb Test
Week 3
|
3.8 Seconds
Standard Deviation 1.0
|
3.6 Seconds
Standard Deviation 0.8
|
3.7 Seconds
Standard Deviation 1.0
|
3.6 Seconds
Standard Deviation 1.3
|
|
Lower Extremity Strength- Timed Stair Climb Test
Week 6
|
3.7 Seconds
Standard Deviation 0.9
|
3.4 Seconds
Standard Deviation 0.6
|
3.5 Seconds
Standard Deviation 1.1
|
3.7 Seconds
Standard Deviation 0.9
|
|
Lower Extremity Strength- Timed Stair Climb Test
Week 9
|
3.3 Seconds
Standard Deviation 1.0
|
3.3 Seconds
Standard Deviation 0.7
|
3.5 Seconds
Standard Deviation 1.2
|
3.4 Seconds
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 0, 3, 6, and 9 weeksMobility was measured by the number of step down repetitions completed in 30 seconds.
Outcome measures
| Measure |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Lower Extremity Mobility- Forward Step-down Test
Week 3
|
11.8 Number of Repetitions
Standard Deviation 4.8
|
15.4 Number of Repetitions
Standard Deviation 5.0
|
12.9 Number of Repetitions
Standard Deviation 4.3
|
14.4 Number of Repetitions
Standard Deviation 5.6
|
|
Lower Extremity Mobility- Forward Step-down Test
Week 0
|
10.8 Number of Repetitions
Standard Deviation 4.9
|
13.2 Number of Repetitions
Standard Deviation 3.9
|
11.3 Number of Repetitions
Standard Deviation 3.6
|
11.2 Number of Repetitions
Standard Deviation 4.0
|
|
Lower Extremity Mobility- Forward Step-down Test
Week 6
|
13.9 Number of Repetitions
Standard Deviation 5.4
|
17.0 Number of Repetitions
Standard Deviation 4.9
|
14.0 Number of Repetitions
Standard Deviation 5.6
|
15.3 Number of Repetitions
Standard Deviation 4.9
|
|
Lower Extremity Mobility- Forward Step-down Test
Week 9
|
14.9 Number of Repetitions
Standard Deviation 5.7
|
17.7 Number of Repetitions
Standard Deviation 5.2
|
16.3 Number of Repetitions
Standard Deviation 5.3
|
18.0 Number of Repetitions
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: 0, 3, 6, and 9 weeksMobility was measured by the distance walked at a fast pace over 6-minutes.
Outcome measures
| Measure |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 0
|
23999 Inches
Standard Deviation 2979
|
24612 Inches
Standard Deviation 2964
|
23931 Inches
Standard Deviation 2772
|
23174 Inches
Standard Deviation 2638
|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 3
|
24951 Inches
Standard Deviation 3407
|
24373 Inches
Standard Deviation 3053
|
24919 Inches
Standard Deviation 2804
|
24102 Inches
Standard Deviation 2996
|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 6
|
25284 Inches
Standard Deviation 3426
|
24970 Inches
Standard Deviation 2582
|
25772 Inches
Standard Deviation 3204
|
24753 Inches
Standard Deviation 2311
|
|
Lower Extremity Mobility- 6-Minute Walk Test
Week 9
|
25847 Inches
Standard Deviation 3763
|
25059 Inches
Standard Deviation 3073
|
25892 Inches
Standard Deviation 3300
|
25227 Inches
Standard Deviation 2655
|
SECONDARY outcome
Timeframe: 0, 3, 6, and 9 weeksCurrent Knee Pain 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 |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Current Knee Pain
Week 0
|
4.24 score on a scale
Standard Deviation 1.76
|
3.48 score on a scale
Standard Deviation 1.84
|
3.42 score on a scale
Standard Deviation 1.66
|
3.98 score on a scale
Standard Deviation 1.77
|
|
Current Knee Pain
Week 3
|
3.44 score on a scale
Standard Deviation 2.13
|
2.99 score on a scale
Standard Deviation 1.99
|
2.78 score on a scale
Standard Deviation 1.71
|
3.02 score on a scale
Standard Deviation 1.91
|
|
Current Knee Pain
Week 6
|
3.76 score on a scale
Standard Deviation 2.05
|
2.90 score on a scale
Standard Deviation 2.20
|
2.28 score on a scale
Standard Deviation 1.50
|
2.72 score on a scale
Standard Deviation 1.80
|
|
Current Knee Pain
Week 9
|
3.01 score on a scale
Standard Deviation 2.33
|
2.77 score on a scale
Standard Deviation 2.22
|
2.44 score on a scale
Standard Deviation 1.79
|
3.27 score on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: 0, 3, 6, and 9 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 |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Knee Pain Following Performance Testing- 30-Second Chair Stand Test
Week 0
|
3.9 score on a scale
Standard Deviation 1.8
|
2.9 score on a scale
Standard Deviation 1.8
|
2.8 score on a scale
Standard Deviation 1.7
|
3.6 score on a scale
Standard Deviation 2.0
|
|
Knee Pain Following Performance Testing- 30-Second Chair Stand Test
Week 3
|
3.5 score on a scale
Standard Deviation 2.0
|
2.9 score on a scale
Standard Deviation 1.9
|
2.2 score on a scale
Standard Deviation 1.7
|
2.9 score on a scale
Standard Deviation 2.2
|
|
Knee Pain Following Performance Testing- 30-Second Chair Stand Test
Week 6
|
3.6 score on a scale
Standard Deviation 2.1
|
2.8 score on a scale
Standard Deviation 2.2
|
2.3 score on a scale
Standard Deviation 1.7
|
2.9 score on a scale
Standard Deviation 2.3
|
|
Knee Pain Following Performance Testing- 30-Second Chair Stand Test
Week 9
|
2.6 score on a scale
Standard Deviation 2.2
|
2.8 score on a scale
Standard Deviation 2.2
|
2.5 score on a scale
Standard Deviation 1.9
|
2.6 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 0, 3, 6, and 9 weeksKnee pain intensity after the Stair Climb 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 |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Knee Pain Following Performance Testing- Stair Climb Test
Week 0
|
3.5 score on a scale
Standard Deviation 1.9
|
2.7 score on a scale
Standard Deviation 1.9
|
2.7 score on a scale
Standard Deviation 1.8
|
3.0 score on a scale
Standard Deviation 2.2
|
|
Knee Pain Following Performance Testing- Stair Climb Test
Week 3
|
3.4 score on a scale
Standard Deviation 2.0
|
2.6 score on a scale
Standard Deviation 2.1
|
2.3 score on a scale
Standard Deviation 1.5
|
2.4 score on a scale
Standard Deviation 2.1
|
|
Knee Pain Following Performance Testing- Stair Climb Test
Week 6
|
3.6 score on a scale
Standard Deviation 2.3
|
2.7 score on a scale
Standard Deviation 2.0
|
2.1 score on a scale
Standard Deviation 1.7
|
2.2 score on a scale
Standard Deviation 2.1
|
|
Knee Pain Following Performance Testing- Stair Climb Test
Week 9
|
2.7 score on a scale
Standard Deviation 2.3
|
2.7 score on a scale
Standard Deviation 2.0
|
2.0 score on a scale
Standard Deviation 1.8
|
1.9 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 0, 3, 6, and 9 weeksKnee pain intensity after the Forward Step Down 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 |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Knee Pain Following Performance Testing- Forward Step Down Test
Week 0
|
5.2 score on a scale
Standard Deviation 1.9
|
4.2 score on a scale
Standard Deviation 1.5
|
4.2 score on a scale
Standard Deviation 2.2
|
5.3 score on a scale
Standard Deviation 2.1
|
|
Knee Pain Following Performance Testing- Forward Step Down Test
Week 3
|
4.7 score on a scale
Standard Deviation 2.0
|
3.8 score on a scale
Standard Deviation 2.0
|
3.2 score on a scale
Standard Deviation 2.0
|
3.5 score on a scale
Standard Deviation 2.3
|
|
Knee Pain Following Performance Testing- Forward Step Down Test
Week 6
|
4.2 score on a scale
Standard Deviation 2.1
|
3.6 score on a scale
Standard Deviation 2.2
|
3.3 score on a scale
Standard Deviation 1.7
|
3.6 score on a scale
Standard Deviation 2.2
|
|
Knee Pain Following Performance Testing- Forward Step Down Test
Week 9
|
3.3 score on a scale
Standard Deviation 2.1
|
3.5 score on a scale
Standard Deviation 2.2
|
2.8 score on a scale
Standard Deviation 2.1
|
3.2 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 0, 3, 6, and 9 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 |
Self-Managed TENS Program
n=33 Participants
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups received the battery-operated Kneehab® XP with lead wire TENS applicator system. The TENS protocol consisted of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone was alternated for 9 weeks for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
|
Standard Rehabilitation Protocol
n=34 Participants
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Self-Managed NMES Program
n=33 Participants
Neuromuscular electrical stimulation (NMES): NMES training consisted of 20-minute sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session included a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment was used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group received alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
Combined NMES/TENS Program
n=30 Participants
The combined NMES/TENS treatment group received the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES were used (described above). The NMES and the TENS protocol were performed on alternating days. There was a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Home Exercise Program (HEP): HEP taught muscle strengthening exercises and self-management strategies. The exercises were quadriceps strengthening exercises that consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises were active straight leg raises, quadriceps straightening, step up, and squats.
|
|---|---|---|---|---|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 0
|
4.5 score on a scale
Standard Deviation 1.7
|
3.2 score on a scale
Standard Deviation 1.7
|
2.7 score on a scale
Standard Deviation 2.2
|
3.6 score on a scale
Standard Deviation 2.3
|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 3
|
4.3 score on a scale
Standard Deviation 2.0
|
3.3 score on a scale
Standard Deviation 2.0
|
2.5 score on a scale
Standard Deviation 1.6
|
3.2 score on a scale
Standard Deviation 2.2
|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 6
|
3.9 score on a scale
Standard Deviation 2.4
|
3.1 score on a scale
Standard Deviation 2.2
|
2.9 score on a scale
Standard Deviation 2.1
|
2.6 score on a scale
Standard Deviation 1.9
|
|
Knee Pain Following Performance Testing- 6-Minute Walk Test
Week 9
|
2.9 score on a scale
Standard Deviation 2.3
|
3.0 score on a scale
Standard Deviation 2.1
|
2.3 score on a scale
Standard Deviation 2.0
|
2.7 score on a scale
Standard Deviation 2.5
|
Adverse Events
Standard Rehabilitation Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Managed NMES Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Managed TENS Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined NMES/TENS Program
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