search
Back to results

Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads (SCBP)

Primary Purpose

Child, Only, Gait, Unsteady

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Backpack child's body weight
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Child, Only

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Gabriel Gijon Nogueron

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Baseline

5% child's body weight

10% child's body weight

15% child's body weight

20% child's body weight

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 11, 2019
Last Updated
August 24, 2019
Sponsor
University of Malaga
search

1. Study Identification

Unique Protocol Identification Number
NCT03839836
Brief Title
Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads
Acronym
SCBP
Official Title
Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Only, Gait, Unsteady

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trial experimental
Masking
ParticipantInvestigator
Masking Description
The study was a double-blind, five-arm experimental study. This biomechanical study was designed to examine the effect of weight in the gait of the children with the backpack, no follow-up was undertaken. A convenience sample of children was approached The potential recruits are asked to attend a screening appointment Children were asked to walk naturally, facing forward, with their hands out of pockets; wearing light, comfortable clothes, with the BP placed correctly with 5 different weights inside the backpack.
Allocation
Non-Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
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
Arm Title
5% child's body weight
Arm Type
Experimental
Arm Description
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
Arm Title
10% child's body weight
Arm Type
Experimental
Arm Description
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
Arm Title
15% child's body weight
Arm Type
Experimental
Arm Description
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
Arm Title
20% child's body weight
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Backpack child's body weight
Intervention Description
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.
Primary Outcome Measure Information:
Title
OptoGait® system is a system for movement analysis and functional assessment of patients with five-meter instrument walkway test
Description
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
Time Frame
1 hour

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
6 to 12 years
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination. Exclusion Criteria: 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.
Facility Information:
Facility Name
Gabriel Gijon Nogueron
City
Armilla
ZIP/Postal Code
18100
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31434980
Citation
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.
Results Reference
result

Learn more about this trial

Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads

We'll reach out to this number within 24 hrs