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Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools

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ClinicalTrials.gov Identifier: NCT03847259
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
HAhmed, Cairo University

Brief Summary:
The aim of this study is to determine different mechanical posture changes in adolescent females at public schools compared to international schools.

Condition or disease Intervention/treatment
Adolescent Behavior Diagnostic Test: mechanical posture changes

Detailed Description:

Two hundred adolescent female subjects at public schools and in this study. All subjects will be recruited from different schools. 1-Group A: it will be consists of 200 adolescent female from public schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS)and Depression Anxiety Stress Scales-21(DASS-21).

2- Group B: it will be consists of 200 adolescent female from international schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS) and Depression Anxiety Stress Scales-21(DASS-21).


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A(public school)

it will be consists of 200 adolescent female from public schools, their age will be ranged from 13 to 17 years, initiated menstrual cycle and BMI more than 20.mechanical posture changes will be evaluated by Posture screen mobile. back pain and life style will be evaluated by (BackPEI) questionnaire.

pain will be evaluated by VISUAL ANALOG SCALE(VAS) .stress will be evaluated by Depression Anxiety Stress Scales-21(DASS-21).

Diagnostic Test: mechanical posture changes
evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS), Depression Anxiety Stress Scales-21(DASS-21).

B(international school)
it will be consists of 200 adolescent female from international schools their age will be ranged from 13 to 17 years, initiated menstrual cycle and BMI more than 20.mechanical posture changes will be evaluated by Posture screen mobile. back pain and life style will be evaluated by (BackPEI) questionnaire .pain will be evaluated by VISUAL ANALOG SCALE (VAS).stress will be evaluated by Depression Anxiety Stress Scales-21(DASS-21).
Diagnostic Test: mechanical posture changes
evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS), Depression Anxiety Stress Scales-21(DASS-21).




Primary Outcome Measures :
  1. posture deviations [ Time Frame: up to 6months ]
    Lateral shift from the midline and tilting through frontal and lateral views.


Secondary Outcome Measures :
  1. weight [ Time Frame: up to 6months ]
    Anthropometric measurement measure by kilogram (kg).

  2. height [ Time Frame: up to 6months ]
    Anthropometric measurement measure by centimeter (cm).

  3. body mass index (BMI). [ Time Frame: up to 6 months ]
    calculated by dividing weight (in kilograms) by your height (in metres squared). kg/m2

  4. Back Pain and Body Posture Evaluation Instrument (BackPEI) questionnaire [ Time Frame: up to 6months ]
    Back Pain and Body Posture Evaluation Instrument .The BackPEI questionnaire consists of 21 closed questions, which address the occurrence, frequency and intensity of pain, as well as questions on demographic (age, gender) and behavioral factors (level of exercise, competitive or non-competitive practice of exercise, daily hours watching television and using the computer, number of daily hours of sleep, reading and/or studying in bed, and postures in activities of daily living.

  5. Visual analogue scale [ Time Frame: up to 6months ]
    Numerical pain rating scale (minimum score 0 and maximum score 10) ,Instruct the patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain.

  6. Depression Anxiety Stress Scales-21(DASS-21) [ Time Frame: up to 6months ]
    Was developed to provide a self-report measure of anxiety, depression and stress signals. During the development process.Questionnaire consists of 21 questions,seven questions for depression ,seven for anxiety and seven for stress assessment.The responses are given on a 4-point Likert scale, ranging from zero if "I strongly disagree" to 3 if "I totally agree". Overall scores for the three constructs are calculated as the sum of scores for the relevant seven items multiplied by two. Ranges of scores correspond to levels of symptoms, ranging from "normal" to "extremely serious



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   both boys and g( da Rosa et al., 2017). They found that girls had poor posture due to the way they carried their school supplies (da Rosa et al., 2017).irls presented a constant frequency in back pain and poor sitting posture, but girls presented higher prevalence along
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescent female at schools.
Criteria

Inclusion Criteria:

  1. Adolescent female at schools.
  2. Their age will be ranged from 13 to 17 years.
  3. BMI more than 20.
  4. Initiated menstrual cycle.

Exclusion Criteria:

  1. Asthma and chronic respiratory disease.
  2. History of upper and lower limb injury.
  3. Under weight subjects.
  4. Females with congenital spinal deformities.
  5. Diabetes, cardiopulmonary diseases and any physical impairment that prevent following the study program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847259


Contacts
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Contact: amal mo youssef, phD 0106792979 prof_amel@hotmail.com
Contact: hamada ah hamada, phD 01117893697 rabiaallah97@yahoo.com

Locations
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Egypt
Cairo university Recruiting
Cairo, Egypt, 14788
Contact: doaa sa mohamed    01117426666    doaa_saeed86@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: fahema me okeel, phD Cairo University

Additional Information:

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Responsible Party: HAhmed, Lecturer of biomechanics, Cairo University
ClinicalTrials.gov Identifier: NCT03847259     History of Changes
Other Study ID Numbers: MPCAF
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No