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CompletedNCT02725645BLSMAUpdated Oct 28, 2019Results posted

Backpack Load and Spine Muscles Activity

An interventional study of loading conditions in Child, sponsored by University Fernando Pessoa. Completed. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-28.

Sponsored by University Fernando Pessoa · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
6 Years to 10 Years
Sex
All
01

Study summary

The purpose of the present study is to analyze the influence of four backpack loading conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck and lumbar muscles of elementary school children.

Read the detailed description

Elementary school children participated in the present study, between the ages of 6 and 10. Bilateral sternocleidomastoid, rectus abdominis and erector spinae muscles activity were recorded using surface electromyography (sEMG), while tested for the effect of four randomized backpack loading conditions.

02

Conditions studied

  • Child

Keywords

  • Surface electromyography
  • children
  • backpack
03

In context

Lead sponsor

University Fernando Pessoa is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • children with tutor consent

Exclusion criteria

Exclusion Criteria:

  • children with cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Healthy school children

    elementary school children will be presented with different backpack loading conditions

    Other: loading conditions

Interventions

  • Otherloading conditions

    Different backpack loading conditions 0%, 10%, 15% and 20% allocated randomly

06

What researchers measure

Primary outcomes

  1. Muscle Activity as a Measure of Route Mean Square

    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.

    Time frame: one year

07

Results

Posted Oct 28, 2019

Participant flow

elementary school children, male and female, with no history of spine problems. Tutors provided legal authorization.

Participant flow — Overall Study
MilestoneHealthy School Children
Started14
Completed14
Not completed0

Outcome measures

PrimaryMuscle Activity as a Measure of Route Mean Square

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.

Time frame:
one year
Reported as:
Mean · milivolts
Muscle Activity as a Measure of Route Mean Square
milivoltsHealthy School Children
left lumbar erector spinae at 0% of body weight13.96 ± 8.45
left lumbar erector spinae at 10% of body weight10.70 ± 7.31
left lumbar erector spinae at 15% of body weight10.85 ± 7.47
left lumbar erector spinae at 20% of body weight9.28 ± 5.47
Right lumbar erector spinae at 0% of body weight13.36 ± 8.73
Right lumbar erector spinae at 10% of body weight9.20 ± 7.47
Right lumbar erector spinae at 15% of body weight7.19 ± 3.67
Right lumbar erector spinae at 20% of body weight6.55 ± 2.91
Left cervical erector spinae at 0% of body weight8.56 ± 4.41
Left cervical erector spinae at 10% of body weight7.66 ± 2.43
Left cervical erector spinae at 15% of body weight8.69 ± 3.15
Left cervical erector spinae at 20% of body weight9.85 ± 4.50
Right cervical erector spinae at 0% of body weight7.77 ± 2.89
Right cervical erec spinae at 10% of body weight8.91 ± 3.81
Right cervical erec spinae at 15% of body weight9.32 ± 3.28
Right cervical erec spinae at 20% of body weight11.10 ± 3.67
Left Rectus Abdominis at 0% of body weight3.35 ± 0.29
Left Rectus Abdominis at 10% of body weight3.68 ± 0.60
Left Rectus Abdominis at 15% of body weight4.27 ± 1.77
Left Rectus Abdominis at 20% of body weight4.03 ± 1.16
Right Rectus Abdominis at 0% of body weight3.64 ± 0.32
Right Rectus Abdominis at 10% of body weight3.88 ± 0.29
Right Rectus Abdominis at 15% of body weight4.94 ± 2.58
Right Rectus Abdominis at 20% of body weight4.54 ± 1.50

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy School Children0/14 (0%)0/14 (0%)0/14 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Healthy School Children
<=18 years14
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Healthy School Children
Mean8.93 ± 0.73
Sex: Female, Male
Sex: Female, Male(Participants)Healthy School Children
Female9
Male5
Region of Enrollment
Region of Enrollment(participants)Healthy School Children
Portugal14
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02725645
Lead sponsor
University Fernando Pessoa
Responsible party
Sandra Rodrigues (Lecturer, University Fernando Pessoa) — Principal investigator
First posted
Apr 1, 2016
Start date
Jun 2014
Primary completion
Jul 2015
Completion
Aug 2015
Results posted
Oct 28, 2019
Last update
Oct 28, 2019

Study contacts

Sandra Rodrigues, MSc, Mphil
principal investigator · University Fernando Pessoa

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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