Trial Outcomes & Findings for Combined Application of Electrical Stimulated Antagonist Contraction During Walking (Walking Study) (NCT NCT02730598)
NCT ID: NCT02730598
Last Updated: 2018-06-15
Results Overview
Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque, using an isokinetic dynamometer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Baseline and 12-week follow-up
Results posted on
2018-06-15
Participant Flow
Participant milestones
| Measure |
Hybrid Training System (HTS)
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
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|---|---|---|
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Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Hybrid Training System (HTS)
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Unrelated Injury affecting outcomes.
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1
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0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hybrid Training System (HTS)
n=14 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=14 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
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Total
n=28 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
59.21 years
STANDARD_DEVIATION 10.02 • n=14 Participants
|
58.29 years
STANDARD_DEVIATION 6.35 • n=14 Participants
|
58.75 years
STANDARD_DEVIATION 8.19 • n=28 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
97.1 kilograms (kg)
STANDARD_DEVIATION 9.6 • n=14 Participants
|
95.6 kilograms (kg)
STANDARD_DEVIATION 12.6 • n=14 Participants
|
96.4 kilograms (kg)
STANDARD_DEVIATION 11.1 • n=28 Participants
|
|
Height
|
161.5 centimeters (cm)
STANDARD_DEVIATION 6.6 • n=14 Participants
|
163.5 centimeters (cm)
STANDARD_DEVIATION 8.6 • n=14 Participants
|
162.5 centimeters (cm)
STANDARD_DEVIATION 7.6 • n=28 Participants
|
|
Body Mass Index (BMI)
|
37.4 kilograms per meters squared (kg/m2)
STANDARD_DEVIATION 4.2 • n=14 Participants
|
35.8 kilograms per meters squared (kg/m2)
STANDARD_DEVIATION 2.9 • n=14 Participants
|
36.6 kilograms per meters squared (kg/m2)
STANDARD_DEVIATION 3.6 • n=28 Participants
|
|
20-Meter Walk Time
|
12.5 seconds
STANDARD_DEVIATION 2.0 • n=14 Participants
|
12.9 seconds
STANDARD_DEVIATION 2.0 • n=14 Participants
|
12.7 seconds
STANDARD_DEVIATION 2.0 • n=28 Participants
|
|
5-Chair Stand Time
|
11.9 seconds
STANDARD_DEVIATION 3.1 • n=14 Participants
|
15.2 seconds
STANDARD_DEVIATION 4.6 • n=14 Participants
|
13.6 seconds
STANDARD_DEVIATION 3.8 • n=28 Participants
|
|
Stair Climb Time
|
6.4 seconds
STANDARD_DEVIATION 1.3 • n=14 Participants
|
6.7 seconds
STANDARD_DEVIATION 2.5 • n=14 Participants
|
6.5 seconds
STANDARD_DEVIATION 1.9 • n=28 Participants
|
|
Knee Extension Torque
|
79.6 Newton-meters (Nm)
STANDARD_DEVIATION 35.9 • n=14 Participants
|
71.7 Newton-meters (Nm)
STANDARD_DEVIATION 42.2 • n=14 Participants
|
75.6 Newton-meters (Nm)
STANDARD_DEVIATION 39.1 • n=28 Participants
|
|
Knee Flexion Torque
|
36.8 Newton-meters (Nm)
STANDARD_DEVIATION 22.0 • n=14 Participants
|
26.3 Newton-meters (Nm)
STANDARD_DEVIATION 19.2 • n=14 Participants
|
31.6 Newton-meters (Nm)
STANDARD_DEVIATION 20.6 • n=28 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
|
14.7 units on a scale
STANDARD_DEVIATION 4.7 • n=14 Participants
|
17.1 units on a scale
STANDARD_DEVIATION 4.0 • n=14 Participants
|
15.9 units on a scale
STANDARD_DEVIATION 4.4 • n=28 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) sub scale
|
9.1 units on a scale
STANDARD_DEVIATION 2.6 • n=14 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 3.0 • n=14 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 2.8 • n=28 Participants
|
|
Knee Pain by Visual Analog Scale
|
31.6 millimeters (mm)
STANDARD_DEVIATION 23.4 • n=14 Participants
|
43.6 millimeters (mm)
STANDARD_DEVIATION 22.2 • n=14 Participants
|
37.6 millimeters (mm)
STANDARD_DEVIATION 22.8 • n=28 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12-week follow-upParticipants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque, using an isokinetic dynamometer.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Change in Knee Extensor Strength Assessed by Isokinetic Dynamometer.
|
9.6 Newton-meters (Nm)
Standard Error 10.8
|
3.8 Newton-meters (Nm)
Standard Error 28.9
|
SECONDARY outcome
Timeframe: Baseline and 12-week follow-upParticipants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee flexor torque, using an isokinetic dynamometer.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Change in Knee Flexor Strength Assessed by Isokinetic Dynamometer
|
9.3 Newton-meters (Nm)
Standard Deviation 9.7
|
6.3 Newton-meters (Nm)
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Baseline and 12-week follow-upKnee pain will be evaluated using a visual analog scale (VAS) of 100 mm from no pain (0 mm) to the worst imaginable pain (100 mm). Participants will be asked to record their pain levels of the past one week.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Change in Knee Pain Assessed by a Visual Analog Scale (VAS)
|
-14.9 millimeters (mm)
Standard Error 27.1
|
-11.9 millimeters (mm)
Standard Error 23.1
|
SECONDARY outcome
Timeframe: Baseline and 12-week follow-upThe Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale was used at baseline and follow-up to assess participant outcomes. The pain subscale is made up of 9 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Change in Knee Pain Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)
|
-5.4 units on a scale
Standard Deviation 4.0
|
-5.3 units on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and 12-week follow-upThe Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale was used at baseline and follow-up to assess participant outcomes. The QOL subscale is made up of 4 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
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|---|---|---|
|
Change in Quality of Life (QOL) Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)
|
-2.6 units on a scale
Standard Deviation 1.9
|
-2.4 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and 12-week follow-upAverage time of two trials used for each participant.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Change in 20-meter Walk Time.
|
-0.53 seconds
Standard Deviation 0.9
|
-0.52 seconds
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and 12-week follow-upAverage time of two trials used for each participant.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Change in 5-chair Stand Time.
|
-1.5 seconds
Standard Deviation 1.5
|
-2.4 seconds
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and 12-week follow-upAverage time of two trials used for each participant.
Outcome measures
| Measure |
Hybrid Training System (HTS)
n=10 Participants
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=10 Participants
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Change in Stair Climb Time.
|
-0.8 seconds
Standard Deviation 0.5
|
-1.4 seconds
Standard Deviation 1.4
|
Adverse Events
Hybrid Training System (HTS)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Transcutaneous Electrical Nerve Stimulation (TENS)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hybrid Training System (HTS)
n=14 participants at risk
HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
|
Transcutaneous Electrical Nerve Stimulation (TENS)
n=14 participants at risk
Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increased Knee Pain during Intervention
|
14.3%
2/14 • Adverse event data was collected over the duration of the study from baseline to 12-week follow-up.
|
7.1%
1/14 • Adverse event data was collected over the duration of the study from baseline to 12-week follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place