Child, OnlySCBPNCT03839836
Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads
A study testing Backpack child's body weight in people with Child, Only and Gait, Unsteady, run by University of Malaga at 1 site in Spain.
Trial summary
Backpacks (BP) represent the method most used by students to transport external cargo. Previous studies cite that between 4.7% and 38% of children carry daily BP loads greater than 20% of their body mass. The purpose of this study was to analyze spatiotemporal parameters of gait in children using varyingly loaded BPs. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Gait, Unsteady
- What is being tested?
- Backpack child's body weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination.
Who cannot join
- The exclusion criteria were: recent injury to the lower limb and back, alterations in the foot bones, congenital structural changes to the ankle, flatfoot associated with cerebral palsy, surgical treatment of foot or lower leg, or any genetic, neurologic or muscular conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads: Clinical Trial
Backpacks (BP) represent the method most used by students to transport external cargo. Previous studies cite that between 4.7% and 38% of children carry daily BP loads greater than 20% of their body mass. The purpose of this study was to analyze spatiotemporal parameters of gait in children using varyingly loaded BPs.
Read the detailed description
This study examined 231 schoolchildren (118 boys, 113 girls) aged six to 12 years, carrying a traditional BP to manipulate loading (Crossing Backpack Children Arpenaz 7 Litres, Junior Red Quechua). The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination. The exclusion criteria were: recent injury to the lower limb and back, alterations in the foot bones, congenital structural changes to the ankle, flatfoot associated with cerebral palsy, surgical treatment of foot or lower leg, or any genetic, neurologic or muscular conditions.
The parents were provided with information about the study, and those consenting for their children to participate, also completed a questionnaire. The children were fully informed of the procedures involved and gave assent. All procedures were in accordance with the ethical standards of the institution of University of Malaga (CEUMA 91/2016H) and with the 1964 Helsinki declaration.
Load was added to the BPs in increments of 5%, 10%, 15% and 20% of the child's body weight. Spatio-temporal parameters were measured with the OptoGait® system.
Two examiners were responsible for the system software and collecting data. General information, including height and weight, were recorded. To measure gait parameters, the protocol used for the Optogait reliability testing was used. This involved the children walking on a walkway at a comfortable speed, repeating this walk three times and calculating the mean speed. Prior to data collection, the children performed one familiarization trial for five minutes. Children were asked to walk naturally, facing forward, with their hands out of pockets; wearing light, comfortable clothes, with the BP placed correctly. As the children started walking, the researchers selected the foot of the first step inside the bars, in the Optogait software. After being instructed to 'walk slowly at a comfortable speed', the children walked from a point two metres in front of the bar and stopped at a point two metres behind the last bar, to minimize effects of acceleration and deceleration
- Conditions
- Child, Only, Gait, Unsteady
- Being tested
- Backpack child's body weight
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backpack child's body weightOther
Children are asked to walk naturally, facing forward, with their hands out of pockets; wearing light, comfortable clothes, with the BP placed correctly. As the children start walking, the researchers select the foot of the first step inside the bars, in the Optogait software. After being instructed to 'walk slowly at a comfortable speed', the children walk from a point two metres in front of the bar and stop at a point two metres behind the last bar, to minimize effects of acceleration and deceleration . A three-minute interval occurs between individual assessments to transmit the data, as well as to prepare for the next assessment. Only steps in the sensor areas are included in the analysis. Recording six to eight strides is reported as sufficient to obtain representative data for unimpaired adults. Subsequently, five experimental conditions are measured: without BP, BP loads of 5%, 10%, 15%, and 20% of body weight. The order of these loaded conditions are random.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Children between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack without the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system |
| 5% child's body weight | Experimental | Children between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 5%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system Receives: Other: Backpack child's body weight |
| 10% child's body weight | Experimental | Children between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 10%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system Receives: Other: Backpack child's body weight |
| 15% child's body weight | Experimental | Children between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 15%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system Receives: Other: Backpack child's body weight |
| 20% child's body weight | Experimental | Children between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 20%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system Receives: Other: Backpack child's body weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
OptoGait® system is a system for movement analysis and functional assessment of patients with five-meter instrument walkway test
The Optogait is a reliable and validated system, which records 19 spatio-temporal parameters. For this study, a five-metre instrument walkway is used, consisting of five transmission bars and five reception bars, with a separation of 120cm. Each bar (100cm x 8cm) contains 96 light emitters 3mm from the ground. Optical sensors operate at a frequency of 1000 Hz, with accuracy of 1cm, to detect the spatio-temporal parameters related to walking, running and other movements. The software use is OptoGait® v.1.11.1.0. The Optogait system is calibrated and checked for accuracy at all times, and provided an exhaustive, reliable measurement of the spatiotemporal phases of the gait cycle
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start2 Nov 2018
- Primary completion16 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Clinical trial experimental
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Gijon-Nogueron, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839836
- Sponsor's protocol ID
- UMalagaHS
- Acronym
- SCBP
- Status last verified
- Aug 2019
- First submitted
- 11 Feb 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paez-Moguer J, Montes-Alguacil J, Garcia-Paya I, Medina-Alcantara M, Evans AM, Gijon-Nogueron G. Variation of spatiotemporal parameters in school children carrying different backpack loads: a cross sectional study. Sci Rep. 2019 Aug 21;9(1):12192. doi: 10.1038/s41598-019-48675-3.
PubMed 31434980
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads: Clinical Trial
- ClinicalTrials.gov ID
- NCT03839836
- Acronym / sponsor ID
- SCBP / UMalagaHS
- Conditions
- Child, Only, Gait, Unsteady
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Backpacks (BP) represent the method most used by students to transport external cargo. Previous studies cite that between 4.7% and 38% of children carry daily BP loads greater than 20% of their body mass. The purpose of this study was to analyze spatiotemporal parameters of gait in children using varyingly loaded BPs.
Detailed description
This study examined 231 schoolchildren (118 boys, 113 girls) aged six to 12 years, carrying a traditional BP to manipulate loading (Crossing Backpack Children Arpenaz 7 Litres, Junior Red Quechua). The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination. The exclusion criteria were: recent injury to the lower limb and back, alterations in the foot bones, congenital structural changes to the ankle, flatfoot associated with cerebral palsy, surgical treatment of foot or lower leg, or any genetic, neurologic or muscular conditions.
The parents were provided with information about the study, and those consenting for their children to participate, also completed a questionnaire. The children were fully informed of the procedures involved and gave assent. All procedures were in accordance with the ethical standards of the institution of University of Malaga (CEUMA 91/2016H) and with the 1964 Helsinki declaration.
Load was added to the BPs in increments of 5%, 10%, 15% and 20% of the child's body weight. Spatio-temporal parameters were measured with the OptoGait® system.
Two examiners were responsible for the system software and collecting data. General information, including height and weight, were recorded. To measure gait parameters, the protocol used for the Optogait reliability testing was used. This involved the children walking on a walkway at a comfortable speed, repeating this walk three times and calculating the mean speed. Prior to data collection, the children performed one familiarization trial for five minutes. Children were asked to walk naturally, facing forward, with their hands out of pockets; wearing light, comfortable clothes, with the BP placed correctly. As the children started walking, the researchers selected the foot of the first step inside the bars, in the Optogait software. After being instructed to 'walk slowly at a comfortable speed', the children walked from a point two metres in front of the bar and stopped at a point two metres behind the last bar, to minimize effects of acceleration and deceleration
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Clinical trial experimental
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Children between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack without the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system |
| 5% child's body weight | Experimental | Other: Backpack child's body weightChildren between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 5%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system |
| 10% child's body weight | Experimental | Other: Backpack child's body weightChildren between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 10%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system |
| 15% child's body weight | Experimental | Other: Backpack child's body weightChildren between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 15%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system |
| 20% child's body weight | Experimental | Other: Backpack child's body weightChildren between six and 12 years, no pain in the lower limb and back at the time of examination using a backpack load was added to the BPs 20%, of the child's body weight, the spatio-temporal parameters are measured with the OptoGait® system |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination.
Key exclusion criteria (1 listed)
- The exclusion criteria were: recent injury to the lower limb and back, alterations in the foot bones, congenital structural changes to the ankle, flatfoot associated with cerebral palsy, surgical treatment of foot or lower leg, or any genetic, neurologic or muscular conditions.
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 |
|---|---|---|
| Backpack child's body weightChildren are asked to walk naturally, facing forward, with their hands out of pockets; wearing light, comfortable clothes, with the BP placed correctly. As the children start walking, the researchers select the foot of the first step inside the bars, in the Optogait software. After being instructed to 'walk slowly at a comfortable speed', the children walk from a point two metres in front of the bar and stop at a point two metres behind the last bar, to minimize effects of acceleration and deceleration . A three-minute interval occurs between individual assessments to transmit the data, as well as to prepare for the next assessment. Only steps in the sensor areas are included in the analysis. Recording six to eight strides is reported as sufficient to obtain representative data for unimpaired adults. Subsequently, five experimental conditions are measured: without BP, BP loads of 5%, 10%, 15%, and 20% of body weight. The order of these loaded conditions are random. | Other | 10% child's body weight, 15% child's body weight, 20% child's body weight, 5% child's body weight |
Primary outcome
OptoGait® system is a system for movement analysis and functional assessment of patients with five-meter instrument walkway test
Time frame: 1 hour
The Optogait is a reliable and validated system, which records 19 spatio-temporal parameters. For this study, a five-metre instrument walkway is used, consisting of five transmission bars and five reception bars, with a separation of 120cm. Each bar (100cm x 8cm) contains 96 light emitters 3mm from the ground. Optical sensors operate at a frequency of 1000 Hz, with accuracy of 1cm, to detect the spatio-temporal parameters related to walking, running and other movements. The software use is OptoGait® v.1.11.1.0. The Optogait system is calibrated and checked for accuracy at all times, and provided an exhaustive, reliable measurement of the spatiotemporal phases of the gait cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Results publication: PubMed 31434980Paez-Moguer J, Montes-Alguacil J, Garcia-Paya I, Medina-Alcantara M, Evans AM, Gijon-Nogueron G. Variation of spatiotemporal parameters in school children carrying different backpack loads: a cross sectional study. Sci Rep. 2019 Aug 21;9(1):12192. doi: 10.1038/s41598-019-48675-3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backpack child's body weight in people with Child, Only and Gait, Unsteady, run by University of Malaga at 1 site in Spain.
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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OptoGait® system is a system for movement analysis and functional assessment of patients with five-meter instrument walkway test (time frame: 1 hour). 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 NCT03839836, which also lists 1 linked publication.
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 Aug 2019.