- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05095883
Correlation Between Body Weight and Foot Progression Angle in Adolescents
January 20, 2024 updated by: Amira Hussin Hussin Mohammed, Delta University for Science and Technology
Obesity is associated with functional decline , altered spatiotemporal gait parameters (e.g.
lower gait speed, shorter strides, and increased step width), and a significantly higher metabolic cost of walking compared to people with normal body weight.
Obesity also negatively affects balance control.This study will investigate foot progression angle in adolescents related to their weight and category classification based on the CDC (Centers for Disease Control and Prevention) growth charts.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- AAA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Two hundred healthy non-athletic children from both sexes will participate in this study.
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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obese
Children in this group will be obese category according to CDC chart which ranged from BMI-for-age > 95th percentiles
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underweight
Children in this group will be underweight category according to CDC chart ranged from BMI-for-age < 5th percentiles
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healthy
Children in this group will be healthy category according to CDC chart which ranged from BMI-for-age 5th to 85th percentiles
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overweight
Children in this group will be overweight category according to CDC chart which ranged from BMI-for-age 85th to 95th percentiles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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foot progression angle for healthy group
Time Frame: assessed immediately after the procedure
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participants in healthy group will be assessed for foot progression angle (FPA).
The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait
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assessed immediately after the procedure
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foot progression angle for overweight group
Time Frame: assessed immediately after the procedure
|
participants in overweight group will be assessed for foot progression angle (FPA).
The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
|
assessed immediately after the procedure
|
|
foot progression angle for obese group
Time Frame: assessed immediately after the procedure
|
participants in obese group will be assessed for foot progression angle (FPA).
The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
|
assessed immediately after the procedure
|
|
foot progression angle for underweight group
Time Frame: assessed immediately after the procedure
|
participants in underweight group will be assessed for foot progression angle (FPA).
The FPA is defined as the angle made by the long axis of the foot from the heel to 2nd metatarsal and the line of progression of gait.
|
assessed immediately after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2021
Primary Completion (Actual)
July 27, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
September 17, 2021
First Submitted That Met QC Criteria
October 15, 2021
First Posted (Actual)
October 27, 2021
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 20, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- adolecents foot angles
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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