Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads

NCT03839836 | Completed DMC

• 1 other identifier: UMalagaHS
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Child, Only; Gait, Unsteady

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour

Study Arms (5)

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

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

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

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

Other: Backpack child's body weight

Interventions

Backpack child's body weight OTHER

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.

10% child's body weight; 15% child's body weight; 20% child's body weight; 5% child's body weight

Eligibility Criteria

• Age: 6 Years - 12 Years
• Gender Eligibility Details: 6 to 12 years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Gabriel Gijon Nogueron

Armilla, 18100, Spain

Location

Related Publications (1)

• 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.

  PMID: 31434980 RESULT

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Clinical trial experimental

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: November 2, 2018
• Primary Completion: January 16, 2019
• Study Completion: February 28, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)