Weight Variation on Cop

June 9, 2024 updated by: Amira Hussin Hussin Mohammed

Impact of Weight Variation on Cop Displacement During Unperturbed Standing Conditions in Adolescents

This study will be conducted to investigate the impact of variant weights in adolescents during unperturbed standing conditions.

Study Overview

Status

Completed

Conditions

Detailed Description

200 adolescents from both sexes will be assigned to this study. They will be selected randomly from a secondary school student and first level university students. They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).The FREEMED platform and FREESTEP software were used to assess the following parameters for each subject:

  1. Sway length (mm).
  2. The Maximum (peak) Oscillation of COP.
  3. The minimum Oscillation of COP.

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

  • Egypt
      • Gamasa, Egypt, 35712
        • Amira Hussin Mohammed

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).

Description

Inclusion criteria:

  • Their age will be ranging from 16 to 18 years.
  • The sample will be selected according to (BMI-for Age percentile) growth charts according to CDC (Centers for Disease Control and Prevention) (appendix-1) (NCHS, 2014)
  • All participant will be free from any musculoskeletal deformities.
  • All participant are free of peripheral neuropathic diseases.
  • They have no visual or auditory or vestibular disorders.
  • They will able to understand, follow and execute instructions included in the testing analysis procedures.

Exclusion criteria:

  • All adolescent associated with any musculoskeletal deformities.
  • All adolescent associated with any foot deformity.
  • All adolescent had a previous foot orthopedic procedure.
  • All adolescent has visual or auditory or vestibular disorder.
  • All adolescent has peripheral neuropathy.
  • Adolescent with morbid obesity BMI >99th for age percentile (Barlow, 2007).

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
Underweight group
This group will be underweight group according to BMI- for age percentile growth chart ranged from BMI-for-age < 5th percentiles.
Normal weight group
This group will be with normal weight according to BMI- for age percentile growth chart which ranged from BMI-for-age 5th to 85th percentiles
Overweight group
This group will be an overweight group according to BMI- for age percentile growth chart which ranged from BMI-for-age 85th to 95th percentiles
Obese group
This group will be obese group according to BMI- for age percentile growth chart which ranged from BMI-for-age > 95th percentiles and <99th percentile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sway length (mm)
Time Frame: through study completion, an average of 6 months
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
through study completion, an average of 6 months
The Maximum (peak) Oscillation of COP
Time Frame: through study completion, an average of 6 months
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
through study completion, an average of 6 months
The minimum Oscillation of COP
Time Frame: through study completion, an average of 6 months
The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amira Hussin Hussin Mohammed

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)

November 1, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • weight variation in COP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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