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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05900843
Other study ID # P.T.REC/012/004234
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2022
Est. completion date January 30, 2023

Study information

Verified date June 2023
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study was to find prevalence and correlations of different weight abnormalities and risk of abdominal obesity in a random sample of Egyptian children suffering from cerebral palsy. This cross- sectional study hypothesize the prevalence of weight abnormalities and risk of abdominal obesity in addition to positive correlations between weight abnormalities and number of exercise hours and frequency of meals in a random sample of Egyptian children suffering from cerebral palsy RESEARCH QUESTION: 1. What is the prevalence of weight abnormalities and and risk of abdominal obesity in Egyptian children with cerebral palsy? 2. Does the weight abnormalities correlates with number of exercise hours or frequency of meals in children with cerebral palsy?


Description:

This cross- sectional study will be conducted to identify the prevalence of weight abnormalities and risk of abdominal obesity in a random sample of Egyptian children suffering from cerebral palsy. It included all cerebral palsy cases at six private pediatric rehabilitation clinics in four different governorates (Cairo, Alexandria, Sharkia and Beni-Suef). Data will be collected from patients, records of the referrals to pediatric physical therapy rehabilitation clinics and measurements of weight, height, waist circumference and hip circumference performed by the therapist. These six settings were selected because;1) They represent different geographical and socioeconomic levels in Egypt, 2) All of them offer pediatric physical therapy rehabilitation sessions at approximately the same range of price ,3) At that time general hospitals were still strictly committed to corona virus control measures, so no data could be available from general hospitals. The following information will be extracted from the patient records: Sex, Age, Diagnosis, subtype of Cerebral Palsy, level of function and degree of spasticity., associated impairments, dietary intake (number of meals or quality of meals) and number of exercise hours per week. A questionnaire will be designed to get the care givers' report about presence of associated impairments, number of meals per day and number of exercising hours per week, type of associated impairments, quality of meals and type of exercises. All care givers of children diagnosed by cerebral palsy will be interviewed by the therapist to help them fill in the questionnaire and to obtain a consent of their participation. BMI; kg/m2 will be calculated by measuring height and weight. WHR will be calculated by measuring waist circumference and hip circumference. BMI and WHR percentiles will be reported according to sex-specific age group standards for growth set by the WHO growth charts.


Recruitment information / eligibility

Status Completed
Enrollment 259
Est. completion date January 30, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - all children diagnosed as Cerebral Palsy between the age of 2 to 18 years old from both sexes in the participating clinics Exclusion Criteria: - Children suffering from developmental motor delays due to any other diagnosis - Children who refused to engage in measurement procedures (weight, height, waist circumference and hip circumference) - Children suffered from fixed deformity that didn't allow to get accurate measurements

Study Design


Locations

Country Name City State
Egypt Tayseer Saber Abdeldayem Cairo

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index weight and height are measured and compared to charts 2 months
Secondary Exercising habits number of exercise hours per week 2 months
Secondary Dietary habits Number of meals per day 2 months
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