NCT06458634

Brief Summary

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

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 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 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 13, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 9, 2024

Last Update Submit

June 9, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

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

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersYes
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).

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) (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.

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 (Barlow, 2007).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

November 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations