Trial Outcomes & Findings for Backpack Load and Spine Muscles Activity (NCT NCT02725645)
NCT ID: NCT02725645
Last Updated: 2019-10-28
Results Overview
EMG signals were initially filtered with a Notch Filter of 50hz, due to the DC power line, using MATLAB 7.11 (v.2010). The signal was then detrended, converted into millivolts and normalized. the normalized signal was then used to calculate the route mean square.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
one year
Results posted on
2019-10-28
Participant Flow
elementary school children, male and female, with no history of spine problems. Tutors provided legal authorization.
Participant milestones
| Measure |
Healthy School Children
Participants had to stand, using backpacks with different load conditions, while being monitored with emg.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Backpack Load and Spine Muscles Activity
Baseline characteristics by cohort
| Measure |
Healthy School Children
n=14 Participants
Participants had to stand with different backpack loading conditions.
|
|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
8.93 years
STANDARD_DEVIATION 0.73 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
Portugal
|
14 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: one yearEMG signals were initially filtered with a Notch Filter of 50hz, due to the DC power line, using MATLAB 7.11 (v.2010). The signal was then detrended, converted into millivolts and normalized. the normalized signal was then used to calculate the route mean square.
Outcome measures
| Measure |
Healthy School Children
n=14 Participants
14 elementary school children participated in the study, 9 female and 5 male.
|
|---|---|
|
Muscle Activity as a Measure of Route Mean Square
left lumbar erector spinae at 0% of body weight
|
13.96 milivolts
Standard Deviation 8.45
|
|
Muscle Activity as a Measure of Route Mean Square
left lumbar erector spinae at 10% of body weight
|
10.70 milivolts
Standard Deviation 7.31
|
|
Muscle Activity as a Measure of Route Mean Square
left lumbar erector spinae at 15% of body weight
|
10.85 milivolts
Standard Deviation 7.47
|
|
Muscle Activity as a Measure of Route Mean Square
left lumbar erector spinae at 20% of body weight
|
9.28 milivolts
Standard Deviation 5.47
|
|
Muscle Activity as a Measure of Route Mean Square
Right lumbar erector spinae at 0% of body weight
|
13.36 milivolts
Standard Deviation 8.73
|
|
Muscle Activity as a Measure of Route Mean Square
Right lumbar erector spinae at 10% of body weight
|
9.20 milivolts
Standard Deviation 7.47
|
|
Muscle Activity as a Measure of Route Mean Square
Right lumbar erector spinae at 15% of body weight
|
7.19 milivolts
Standard Deviation 3.67
|
|
Muscle Activity as a Measure of Route Mean Square
Right lumbar erector spinae at 20% of body weight
|
6.55 milivolts
Standard Deviation 2.91
|
|
Muscle Activity as a Measure of Route Mean Square
Left cervical erector spinae at 0% of body weight
|
8.56 milivolts
Standard Deviation 4.41
|
|
Muscle Activity as a Measure of Route Mean Square
Left cervical erector spinae at 10% of body weight
|
7.66 milivolts
Standard Deviation 2.43
|
|
Muscle Activity as a Measure of Route Mean Square
Left cervical erector spinae at 15% of body weight
|
8.69 milivolts
Standard Deviation 3.15
|
|
Muscle Activity as a Measure of Route Mean Square
Left cervical erector spinae at 20% of body weight
|
9.85 milivolts
Standard Deviation 4.50
|
|
Muscle Activity as a Measure of Route Mean Square
Right cervical erector spinae at 0% of body weight
|
7.77 milivolts
Standard Deviation 2.89
|
|
Muscle Activity as a Measure of Route Mean Square
Right cervical erec spinae at 10% of body weight
|
8.91 milivolts
Standard Deviation 3.81
|
|
Muscle Activity as a Measure of Route Mean Square
Right cervical erec spinae at 15% of body weight
|
9.32 milivolts
Standard Deviation 3.28
|
|
Muscle Activity as a Measure of Route Mean Square
Right cervical erec spinae at 20% of body weight
|
11.10 milivolts
Standard Deviation 3.67
|
|
Muscle Activity as a Measure of Route Mean Square
Left Rectus Abdominis at 0% of body weight
|
3.35 milivolts
Standard Deviation 0.29
|
|
Muscle Activity as a Measure of Route Mean Square
Left Rectus Abdominis at 10% of body weight
|
3.68 milivolts
Standard Deviation 0.60
|
|
Muscle Activity as a Measure of Route Mean Square
Left Rectus Abdominis at 15% of body weight
|
4.27 milivolts
Standard Deviation 1.77
|
|
Muscle Activity as a Measure of Route Mean Square
Left Rectus Abdominis at 20% of body weight
|
4.03 milivolts
Standard Deviation 1.16
|
|
Muscle Activity as a Measure of Route Mean Square
Right Rectus Abdominis at 0% of body weight
|
3.64 milivolts
Standard Deviation 0.32
|
|
Muscle Activity as a Measure of Route Mean Square
Right Rectus Abdominis at 10% of body weight
|
3.88 milivolts
Standard Deviation 0.29
|
|
Muscle Activity as a Measure of Route Mean Square
Right Rectus Abdominis at 15% of body weight
|
4.94 milivolts
Standard Deviation 2.58
|
|
Muscle Activity as a Measure of Route Mean Square
Right Rectus Abdominis at 20% of body weight
|
4.54 milivolts
Standard Deviation 1.50
|
Adverse Events
Healthy School Children
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place