NCT07161349

Brief Summary

What is this study about? This is an observational study that investigates how different ways of carrying a school backpack affect the pressure distribution on the soles of the feet (plantar pressure) in adolescents. The main questions it aims to answer are: Does carrying a backpack on one shoulder (unilaterally) change the pressure on the bottom of the foot compared to carrying it on both shoulders (bilaterally)? Does carrying a backpack change the amount of the foot that touches the ground (contact area)? Are there differences in foot pressure between the right and left foot based on how the backpack is carried? Researchers compared four different carrying conditions to see their effects: Carrying no backpack. Carrying a backpack on both shoulders. Carrying a backpack on the right shoulder only. Carrying a backpack on the left shoulder only. Who participated? The study included 92 healthy adolescent students (32 boys and 60 girls) from Mansoura City, Egypt. Their ages ranged from 12 to 18 years old, they had a normal Body Mass Index (BMI), and had no existing postural or musculoskeletal problems. What did participants do? Participants in the study were asked to: Have their height, weight, and posture checked to ensure they are eligible. Stand and walk barefoot on a special computerized pressure-sensitive mat (a Foot Scan Plate System). Perform these standing and walking tasks under the four different backpack conditions listed above. The backpack was always loaded to weigh 15% of the student's body weight. What did the study find? The key findings were: How you carry the backpack affects how much of your foot touches the ground. Carrying a backpack on one shoulder (especially the right) increased the contact area of both feet on the ground, both while standing and walking. The average and maximum pressures on the soles of the feet did not change significantly. Regardless of how the backpack was carried, the intensity of the pressure under the feet remained relatively the same in these healthy adolescents. Overall balance was maintained. Even though the carrying method changed how the feet contacted the ground, the body compensated well, and no significant imbalance in pressure between the right and left foot was found during walking. What does this mean for patients, families, and healthcare providers? For Teens and Families: This study highlights that how you carry your backpack matters for your foot mechanics. While a brief change may not cause immediate pain, consistently carrying a backpack on one shoulder can alter your posture and gait. It is best to use both shoulder straps to distribute weight evenly and promote healthy body alignment. For Healthcare Providers: This research provides evidence that the backpack carriage method is a modifiable factor influencing plantar loading patterns in adolescents. Assessing a patient's backpack habits could be a useful part of evaluating complaints of foot, knee, or back pain. Educating patients and families on symmetrical load carriage and proper backpack weight (≤15% of body weight) is a valuable preventive strategy. The bottom line: While the body can adapt to short-term uneven loading, making a habit of carrying a backpack on both shoulders is the best practice for supporting healthy foot pressure distribution and overall posture in growing adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

August 30, 2025

Last Update Submit

September 14, 2025

Conditions

Keywords

Plantar pressure distributionCarrying backpackAdolescents

Outcome Measures

Primary Outcomes (1)

  • Change in the Planar pressure distribution across the foot at different backpack carrying conditions.

    The plantar pressure distribution was recorded using the Foot Scan Plate System under different conditions, (Maximum pressure-contact surface area-average pressure) were recorded. The conditions are: 1. Without Backpack 2. Carrying a Backpack with a Unilateral strap on the Left shoulder 3. Carrying a Backpack with a Unilateral strap on the Right shoulder 4. Carrying a Backpack with Bilateral straps on both shoulders

    2 Hours

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted on ninety-two healthy adolescents from both sexes to determine the effect of different backpack carriage styles on plantar pressure distribution in adolescents. They will be recruited from public and private schools in Mansoura city.

You may qualify if:

  • Their age will range from 12 to 18 years.
  • Their body mass index (BMI) is within normal range according to BMI for age percentile score (WHO, 2007).
  • All adolescents will be free from postural deviation, the trunk rotation in all students is within a normal degree determined by scoliometer (Bunnel, 1993).

You may not qualify if:

  • Visual, auditory, or perceptual deficits.
  • Deformities at any joint of the lower limbs and spine.
  • Surgical intervention in the foot.
  • Deep sensory loss.
  • Musculoskeletal disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthomedics

Al Mansurah, Egypt

Location

Related Publications (1)

  • Pau M, Leban B, Corona F, Gioi S, Nussbaum MA. School-based screening of plantar pressures during level walking with a backpack among overweight and obese schoolchildren. Ergonomics. 2016 May;59(5):697-703. doi: 10.1080/00140139.2015.1077275. Epub 2015 Sep 7.

    PMID: 26226045BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. in Physical Therapy

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

January 15, 2022

Primary Completion

July 25, 2023

Study Completion

September 10, 2023

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations