Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-11 @ 3:21 AM
Study NCT ID:
NCT03847259
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2019-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'posture deviations', 'timeFrame': 'up to 6months', 'description': 'Lateral shift from the midline and tilting through frontal and lateral views.'}], 'secondaryOutcomes': [{'measure': 'weight', 'timeFrame': 'up to 6months', 'description': 'Anthropometric measurement measure by kilogram (kg).'}, {'measure': 'height', 'timeFrame': 'up to 6months', 'description': 'Anthropometric measurement measure by centimeter (cm).'}, {'measure': 'body mass index (BMI).', 'timeFrame': 'up to 6 months', 'description': 'calculated by dividing weight (in kilograms) by your height (in metres squared). kg/m2'}, {'measure': 'Back Pain and Body Posture Evaluation Instrument (BackPEI) questionnaire', 'timeFrame': 'up to 6months', 'description': '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.'}, {'measure': 'Visual analogue scale', 'timeFrame': 'up to 6months', 'description': '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.'}, {'measure': 'Depression Anxiety Stress Scales-21(DASS-21)', 'timeFrame': 'up to 6months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Behavior']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine different mechanical posture changes in adolescent females at public schools compared to international schools.', 'detailedDescription': '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).\n\n2- 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescent female at schools.', 'genderDescription': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adolescent female at schools.\n2. Their age will be ranged from 13 to 17 years.\n3. BMI more than 20.\n4. Initiated menstrual cycle.\n\nExclusion Criteria:\n\n1. Asthma and chronic respiratory disease.\n2. History of upper and lower limb injury.\n3. Under weight subjects.\n4. Females with congenital spinal deformities.\n5. Diabetes, cardiopulmonary diseases and any physical impairment that prevent following the study program.'}, 'identificationModule': {'nctId': 'NCT03847259', 'briefTitle': 'Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools', 'orgStudyIdInfo': {'id': 'MPCAF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A(public school)', 'description': '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.\n\npain will be evaluated by VISUAL ANALOG SCALE(VAS) .stress will be evaluated by Depression Anxiety Stress Scales-21(DASS-21).', 'interventionNames': ['Diagnostic Test: mechanical posture changes']}, {'label': 'B(international school)', 'description': '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).', 'interventionNames': ['Diagnostic Test: mechanical posture changes']}], 'interventions': [{'name': 'mechanical posture changes', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS), Depression Anxiety Stress Scales-21(DASS-21).', 'armGroupLabels': ['A(public school)', 'B(international school)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14788', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'fahema me okeel, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of biomechanics', 'investigatorFullName': 'HAhmed', 'investigatorAffiliation': 'Cairo University'}}}}