NCT06458621

Brief Summary

This study will be conducted to investigate the impact of different weight categories of adolescents on the center of pressure displacement throughout posturographic analysis test

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 9, 2024

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Delta (Y)AP sway /mm

    The anteroposterior COP sway length is the total distance traveled by COP in AP axis during the test time . The smaller the delta (y) , the better is the postural stability. It is an effective evaluation index in numerous populations and balance condition.

    Through study completion an average of 5 months

  • Delta (X)ML sway /mm

    Mediolateral COP sway is the total distance traveled by COP in ML axis during the test time . The smaller the delta (x) , the better is the postural stability. It is an effective evaluation index in numerous populations and balance conditions.

    Through study completion an average of 5 months

  • Average COP speed /mm.s

    is calculated by dividing the COP path length by testing time. In addition to the total COP average velocity, the average COP velocity components in the AP and ML directions can also be calculated. COP speed is an indicator of the efficiency of the postural control system. The average COP speed value is small, which is considered a good performance of posture control

    Through study completion an average of 5 months

Study Arms (4)

Underweight group (A):

This group will be underweight group according to BMI- for age percentile growth chart ranged from BMI-for-age \< 5th percentiles.

Normal weight group (B):

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 (C):

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 (D):

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

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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). They will be assigned as following: Normal weight group (B): 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 (C): 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 (D): 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

You may qualify if:

  • 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)(NCHS, 2014)
  • All participant will be free from any musculoskeletal deformities.
  • All participant is 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta university

Gamasa, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dina demonstrator for pediatrics and its surgery delta university, Bachelor

    Delta University for Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator for pediatrics and its surgery

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

November 10, 2023

Primary Completion

April 28, 2024

Study Completion

May 1, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations