Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-24 @ 5:46 PM
Study NCT ID:
NCT04092335
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2019-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-09-14', 'studyFirstSubmitQcDate': '2019-09-14', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of hump measured by Forward Bend Test', 'timeFrame': '20 minutes', 'description': 'Students were asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. Scoliosis were detected with rib cage rotation and hump appearance (positive test). Absence of hump appearance means negative test.'}, {'measure': 'Angle of trunk rotation (ATR) measured by Scoliometer HD application', 'timeFrame': '20 minutes', 'description': 'The students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': "Scoliosis is a lateral curvature of the spine when the Cobb´s angle more than 10˚ on the frontal plane. Curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Purpose of this study was to evaluate Adam's Forward Bend Test and Scoliometer HD in screening of Adolescent Idiopathic Scoliosis", 'detailedDescription': "The student was asked to stand erect, knees straight, feet at the same level and hands freely hanging.\n\nThey was observed from the back for shoulders, pelvic, and knees level. Student was asked to bend forward with his knees straight, feet together and hands freely and loosely hanged(Forward Bend Test).\n\nScoliosis was detected with rib cage rotation and hump appearance (positive test).\n\nAbsence of hump appearance means negative test. After Forward Bend, the students were screened using the Scoliometer HD Application.\n\nThe students were asked to bend forward with arms dangling and palms pressed together. The smart phone (Scoliometer HD) was placed on the student back with the central dark area in the application placed on the spinous processes of the lumber and thoracic regions to measure the angle of trunk rotation. Students with a scoliometer HD reading ≥7 degrees (≥20 ̊ Cobb's angle) were referred to orthopedic consultation and their parents were informed about the findings of the screening by the school manager and social worker.\n\nThen the data were collected for statistical analysis"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male students with age range 10-15 years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 10 to 15 year.\n* Males ( parents of girls refused their participation).\n* Students who have structural scoliosis.\n\nExclusion Criteria:\n\n* Congenital deformities.\n* Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).\n* Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect and spinabifida).'}, 'identificationModule': {'nctId': 'NCT04092335', 'briefTitle': "Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis", 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': "Evaluation of Adam's Forward Bend Test and Smartphone Application in Screening of Adolescent Idiopathic Scoliosis", 'orgStudyIdInfo': {'id': 'P.T.REC/012/002051'}}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Nasr A. Abdelkader, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer,Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Karima Abdelaty Hassan', 'investigatorAffiliation': 'Cairo University'}}}}