Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-29 @ 11:54 PM
Study NCT ID:
NCT05260632
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2022-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Smartphone Addiction on Manual Coordination, Strength and Hand Pain in Normal Teenage Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-19', 'studyFirstSubmitDate': '2022-02-19', 'studyFirstSubmitQcDate': '2022-02-19', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Manual coordination', 'timeFrame': 'Baseline - one hour for each participant', 'description': 'Assessment of change in manual dexterity and upper extremity coordination will be carried out by using The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Bruininks and Bruininks, 2005).'}, {'measure': 'Assessment of hand grip strength', 'timeFrame': 'Baseline - one hour for each participant', 'description': 'Assessment of change in Hand grip strength will be assessed by hand dynamometer device.'}, {'measure': 'Assessment of pinch strength', 'timeFrame': 'Baseline - one hour for each participant', 'description': 'Assessment of change in pinch strength by pinchmeter device.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smart Phone Addiction, Manual Coordination, Hand Grip Strength, Pinch Strength, Teenage Students']}, 'descriptionModule': {'briefSummary': 'Statement of the problem:\n\n• Does addiction of smart phone affect upper limb coordination, manual dexterity, hand grip and pinch strength?\n\nNull Hypotheses:\n\n• Addiction of smart phone does not affect upper limb coordination, manual dexterity, hand grip and pinch strength in normal teenage students.', 'detailedDescription': "Subjects:\n\nThe survey targets the normal teenage students from both sexes. Sample size estimation will be carried out to determine the recruited number of students, selected randomly from both governmental and private preparatory and secondary schools at Ashmoon educational administration, Menofia Governorate to participate in this study.\n\nStudy design:\n\nCross sectional observational study. Sample design will be a cluster sample,\n\nA. Inclusion criteria:\n\n1. The students' age will range from 12 to 18 years.\n2. Normal students including both boys and girls.\n3. Participants have a range score from 31 to 60 points for boys and from 33 to 60 points for girls on smartphone addiction scale according to Kwon et al (2013).\n4. Their body mass index will be within the normal range according to WHO indices .\n5. Cooperative students who wish to participate in the current study.\n6. The students will represent different socioeconomic levels.\n\nB. Exclusion criteria:\n\nThe students will be excluded from the study if they have one of the following:\n\n1. Congenital abnormalities or medical conditions, which may affect the study.\n2. Musculoskeletal problems such as previous or recent orthopedic surgery, fractures, prostheses, inflammation of the fingers, arms, or shoulder.\n3. Visual or hearing defects.\n4. Motor, behavioral, or neurologic disorders and learning disabilities. • Participants have a range score from 31 to 60 points for boys and from 33 to 60 points for girls on smartphone addiction scale, then participants will be divided into 2 levels of addiction.\n\nAssessment of manual dexterity and upper extremity coordination will be carried out by using The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Bruininks and Bruininks, 2005). Hand grip strength and pinch strength will be assessed by hand dynamometer and pinch meter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The students' age will range from 12 to 18 years.\n2. Normal students including both boys and girls.\n3. Participants have a range score from 31 to 60 points for boys and from 33 to 60 points for girls on smartphone addiction scale according to Kwon et al (2013).\n4. Their body mass index will be within the normal range according to WHO indices .\n5. Cooperative students who wish to participate in the current study.\n6. The students will represent different socioeconomic levels.\n\nExclusion Criteria:\n\nThe students will be excluded from the study if they have one of the following:\n\n1. Congenital abnormalities or medical conditions, which may affect the study.\n2. Musculoskeletal problems such as previous or recent orthopedic surgery, fractures, prostheses, inflammation of the fingers, arms, or shoulder.\n3. Visual or hearing defects.\n4. Motor, behavioral, or neurologic disorders and learning disabilities\n\n \\-"}, 'identificationModule': {'nctId': 'NCT05260632', 'briefTitle': 'Effect of Smartphone Addiction on Manual Coordination, Strength and Hand Pain in Normal Teenage Students', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Smartphone Addiction on Manual Coordination, Strength and Hand Pain in Normal Teenage Students', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003440'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no intervention'}, {'label': '2 groups'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34518', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Outpatient clinic, Faculty of Physical Therapy, Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amira Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Amira Eid Mohamed Youssif', 'investigatorAffiliation': 'Cairo University'}}}}