Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT05759702
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2023-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Body Mass Index, Manual Dexterity and Handgrip Strength in School Aged Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-26', 'studyFirstSubmitDate': '2023-02-26', 'studyFirstSubmitQcDate': '2023-02-26', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of manual dexterity', 'timeFrame': 'Baseline-45min for each participant', 'description': 'assessment of manual dexterity will be carried out by using using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Bruininks and Bruininks, 2005).'}, {'measure': '• Handgrip strength', 'timeFrame': 'Baseline-45min for each participant', 'description': '• Handgrip strength will be assessed by hand dynamometer device'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Mass Index,Manual Dexterity,Handgrip Strength,School Aged Children']}, 'descriptionModule': {'briefSummary': 'The purpose of current study is to investigate the relation between body mass index, manual dexterity and handgrip strength in school aged children having normal weight, overweight and obesity.', 'detailedDescription': "The study targeted the normal weight, overweight and obese students (9-11) from both sexes will be selected from governmental primary schools.\n\nStudy design:\n\nCross sectional observational correlational study.\n\nA. Inclusion criteria:\n\n1. The students' age ranges from 9 to 11 years.\n2. Normal weight, Overweight and obese students were included\n3. both boys and girl will be included.\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.\n\n * All children will be assessed using: the Standard weight and height measuring scale to determine their BMI.\n * Assessment of manual dexterity will be carried out by using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Bruininks and Bruininks, 2005).\n * Handgrip strength will be assessed by hand dynamometer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The students' age will range from 9 to 11 years.\n2. Normal weight, Overweight and obese students including both boys and girl.\n\nExclusion Criteria:\n\n* The students will be excluded from the study if they have one of the following:\n\n 1. Congenital abnormalities or medical conditions, which may affect the study.\n 2. Musculoskeletal problems such as previous or recent orthopedic surgery, fractures, prostheses, inflammation of the fingers, arms, or shoulder.\n 3. Visual or hearing defects.\n 4. Motor, behavioral, or neurologic disorders and learning disabilities."}, 'identificationModule': {'nctId': 'NCT05759702', 'briefTitle': 'Correlation Between Body Mass Index, Manual Dexterity and Handgrip Strength in School Aged Children', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between Body Mass Index, Manual Dexterity and Handgrip Strength in School Aged Children', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004242'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal weight', 'description': 'normal weight students will be enrolled in this group their BMI range from 5th percentile to less than the 85th percentile on CDC growth chart'}, {'label': 'overweight', 'description': 'overweight students will be enrolled in this group their BMI range from 85th to less than the 95th percentile on CDC growth chart'}, {'label': 'obese', 'description': 'obese students will be enrolled in this group their BMI range from Equal to or greater than the 95th percentile on CDC growth chart'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'wessam sayed', 'role': 'CONTACT', 'email': 'dareenahmed010@gmail.com', 'phone': '01014258675'}, {'name': 'nanees mohamed', 'role': 'CONTACT', 'email': 'nanessam2015@cu.edu.eg', 'phone': '01115960603'}], 'overallOfficials': [{'name': 'wessam os sayed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'demonstrator', 'investigatorFullName': 'Wessam Osama Sayed', 'investigatorAffiliation': 'Cairo University'}}}}