Weight Variation on Cop

Adolescent Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06458634
• Other study ID #: weight variation in COP
• Status: Completed
• Start date: November 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adolescent Overweight
• Overweight
• Pediatric Obesity

Locations

Country	Name	City	State
Egypt	Amira Hussin Mohammed	Gamasa

Sponsors (1)

Lead Sponsor	Collaborator
Amira Hussin Hussin Mohammed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sway length (mm)	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
Primary	The Maximum (peak) Oscillation of COP	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
Primary	The minimum Oscillation of COP	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