ChildBLSMANCT02725645

Backpack Load and Spine Muscles Activity

A study testing loading conditions in people with Child, run by University Fernando Pessoa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 6 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Child
What is being tested?: loading conditions
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: No sites listed yet
Study dates: Jun 2014to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

children with tutor consent

Who cannot join

children with cognitive impairment

About this study

Official title: Influence of Different Backpack Loading Conditions on Neck and Lumbar Muscles Activity 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.

Conditions: Child
Being tested: loading conditions
Keywords: Surface electromyography, children, backpack

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02725645
Study group	Role	What they receive
Healthy school children	Experimental	elementary school children will be presented with different backpack loading conditions Receives: Other: loading conditions

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Aug 2015

First posted1 Apr 2016 (estimated)
Study startJun 2014
Primary completionJul 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ChildStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02725645
Sponsor's protocol ID: FCS-UFP-2016-03
Acronym: BLSMA
Status last verified: Oct 2019
First submitted: 21 Mar 2016
Last updated: 28 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Child trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Different Backpack Loading Conditions on Neck and Lumbar Muscles Activity of Elementary School Children
ClinicalTrials.gov ID: NCT02725645
Acronym / sponsor ID: BLSMA / FCS-UFP-2016-03
Conditions: Child
Keywords: Surface electromyography, children, backpack
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University Fernando PessoaUniversity, hospital or other
Study start: Jun 2014
Primary completion: Jul 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 28 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy school children	Experimental	Other: loading conditionselementary school children will be presented with different backpack loading conditions

Who may qualify

Ages: 6 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

children with tutor consent

Key exclusion criteria (1 listed)

children with cognitive impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
loading conditionsDifferent backpack loading conditions 0%, 10%, 15% and 20% allocated randomly	Other	Healthy school children

Primary outcome

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.

Results and safety

Results posted to the registry on 28 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy School Children	14	14

Primary outcome: Muscle Activity as a Measure of Route Mean Square

Time frame: one year. Mean (Standard Deviation). Unit: milivolts

Measure	Healthy School Children n = 14
left lumbar erector spinae at 0% of body weight	13.96 (8.45)
left lumbar erector spinae at 10% of body weight	10.70 (7.31)
left lumbar erector spinae at 15% of body weight	10.85 (7.47)
left lumbar erector spinae at 20% of body weight	9.28 (5.47)
Right lumbar erector spinae at 0% of body weight	13.36 (8.73)
Right lumbar erector spinae at 10% of body weight	9.20 (7.47)
Right lumbar erector spinae at 15% of body weight	7.19 (3.67)
Right lumbar erector spinae at 20% of body weight	6.55 (2.91)

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy School Children	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Child

Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra Rodrigues, MSc, Mphil principal investigator

University Fernando Pessoa

Questions about this trial

What is this clinical trial studying?

A study testing loading conditions in people with Child, run by University Fernando Pessoa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Activity as a Measure of Route Mean Square (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02725645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.