NCT02725645

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

October 28, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

March 21, 2016

Results QC Date

January 12, 2019

Last Update Submit

October 24, 2019

Conditions

Child

Keywords

Surface electromyographychildrenbackpack

Outcome Measures

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.

    one year

Study Arms (1)

Healthy school children

EXPERIMENTAL

elementary school children will be presented with different backpack loading conditions

Other: loading conditions

Interventions

loading conditionsOTHER

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

Healthy school children

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children with tutor consent

You may not qualify if:

  • children with cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Sandra Beatriz Pereira Rodrigues
Organization
Universidade Fernando Pessoa
sandrar@ufp.edu.pt

Study Officials

  • Sandra Rodrigues, MSc, Mphil

    University Fernando Pessoa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 21, 2016

First Posted

April 1, 2016

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

October 28, 2019

Results First Posted

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share