- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02725645
Backpack Load and Spine Muscles Activity (BLSMA)
October 24, 2019 updated by: Sandra Rodrigues, University Fernando Pessoa
Influence of Different Backpack Loading Conditions on Neck and Lumbar Muscles Activity of Elementary School Children
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children with tutor consent
Exclusion Criteria:
- children with cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy school children
elementary school children will be presented with different backpack loading conditions
|
Different backpack loading conditions 0%, 10%, 15% and 20% allocated randomly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Activity as a Measure of Route Mean Square
Time Frame: one year
|
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.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandra Rodrigues, MSc, Mphil, University Fernando Pessoa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
March 21, 2016
First Submitted That Met QC Criteria
March 28, 2016
First Posted (Estimate)
April 1, 2016
Study Record Updates
Last Update Posted (Actual)
October 28, 2019
Last Update Submitted That Met QC Criteria
October 24, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FCS-UFP-2016-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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