NCT05074511

Brief Summary

Obesity is a global health problem. It changes the measurement of the human body and makes a big change to move the body. The increased weight and mass change the way the limbs and whole body generate and react to force Excess fat also interferes with joint-muscle interactions that are important for functional capacity and postural balance The tendency to increase the thickness of the abdomen contributes to anterior movement of the COM of the body. The purpose of the study is to investigate the biomechanical effect of weight on foot stability in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

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

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

September 29, 2021

Last Update Submit

January 20, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • risk of falling in static and dynamic situations for each group

    The Biodex Balance System will be used to assess risk of falling

    assessed immediately after the procedure

  • dynamic level of stability for each group

    The Biodex Balance System will be used to assess level of instability

    assessed immediately after the procedure

  • dynamic Postural stability for each group

    The Biodex Balance System will be used to assess Postural stability

    aassessed immediately after the procedure

  • ankle muscles peak and angle specific torque, power and work for each group

    Isokinetic dynamometer will be used to assess ankle muscles (plantarflexors, dorsiflexors, inverstors and evertors muscles). it will be assess the peak and angle specific torque, power and work for those muscles.

    assessed immediately after the procedure

Study Arms (4)

healthy

Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles

overweight

Children in this group will be overweight category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 85th to 95th percentiles .

obese

Children in this group will be obese category according to CDC chart which ranged from BMI-for-age \> 95th percentiles

underweight

Children in this group will be underweight category according to CDC chart ranged from BMI-for-age \< 5th percentiles

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Two hundred healthy non-athletic children from both sexes will participate in this study. They will randomly be recruited from primary school stage.

You may qualify if:

  • Their age will be ranging from 7 to 9 years.
  • All children have normal stature for age percentile according to CDC chart.
  • The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts
  • All children are normal \&perform all activities of daily living
  • They were able to understand and follow verbal commands and instructions included in the testing procedures.

You may not qualify if:

  • All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
  • None of them had any surgical intervention in the lower extremities.
  • None of them had any history of musculoskeletal deformities or neuromuscular disorders.
  • They had neither visual, auditory defect.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant. Professor of physical therapy, Department of Physical Therapy for Pediatrics

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

October 15, 2021

Primary Completion

September 28, 2022

Study Completion

October 31, 2022

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations