Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-26 @ 11:02 AM
Study NCT ID:
NCT05899803
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Walkers in Infancy and Musculoskeletal System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053580', 'term': 'Muscle Strength'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '6 months', 'description': 'JTech Commander PowerTrack Muscle Dynamometer'}, {'measure': 'Physical activity level', 'timeFrame': '6 months', 'description': 'Physical Activity Questionnaire for Children (PAQ-C)'}], 'secondaryOutcomes': [{'measure': 'Posture analysis', 'timeFrame': '6 months', 'description': 'New York Posture Analysis Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Baby equipment', 'physical activity', 'muscle strength', 'posture', 'walker'], 'conditions': ['Use of a Walker in Infancy', 'Physical Activity Level', 'Musculoskeletal Problems']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare lower extremity muscle strength, posture disorders and physical activity levels of children with and without walker use during infancy. Thirty-nine children aged between 8 and 15 years were included. Demographic data, New York Posture Analysis Questionnaire and Physical Activity Assessment Questionnaire Scale (PAQ-C) were collected. Muscle strength was measured with a digital muscle strength meter.', 'detailedDescription': 'This study aimed to compare lower extremity muscle strength, postural disorders, and physical activity levels of children who used and did not use a walker during infancy.\n\nThe study included 39 children aged between 8 and 15 years. The demographic information of the children, their motor development stages and walker use situations, the age at which they started using it, and the duration of use were questioned. The New York Posture Analysis Questionnaire and Physical Activity Assessment Questionnaire Scale (PAQ-C) were administered to the children. Muscle strength was measured with a digital muscle strength meter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No idiopathic serious orthopedic problems\n* No chronic disease\n* Children and their parents who volunteered to participate in the study\n\nExclusion Criteria:\n\n* Presence of neurologic disease.\n* Presence of neuromuscular disease.\n* Presence of mental retardation.'}, 'identificationModule': {'nctId': 'NCT05899803', 'briefTitle': 'Use of Walkers in Infancy and Musculoskeletal System', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'The Effect of the Use of a Walker in Infancy on the Musculoskeletal System and the Level of Physical Activity', 'orgStudyIdInfo': {'id': '2023/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Using Walker Group', 'description': 'Children who used baby walkers during childhood were included in this group. All assessment procedures were then performed.', 'interventionNames': ['Diagnostic Test: Posture Analysis', 'Diagnostic Test: Physical activity level', 'Diagnostic Test: Muscle strength']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Walker-Free Group', 'description': 'Children who did not use a baby walker during childhood were included in this group. All assessment procedures were then performed.', 'interventionNames': ['Diagnostic Test: Posture Analysis', 'Diagnostic Test: Physical activity level', 'Diagnostic Test: Muscle strength']}], 'interventions': [{'name': 'Posture Analysis', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['New York Posture Analysis'], 'description': 'This analysis consists of 13 different body parts and evaluates the body in terms of current posture changes. Our study evaluated children from two angles: posterior (head, shoulders, back, hips, feet, and arches) and lateral (neck, chest, shoulders, upper back, trunk, abdomen, and waist). In the scoring system, correct posture was recorded as five points, a moderate amount of deformity posture as three points, and severe deformity posture as one point. The total score calculated at the end of the questionnaire was a maximum of 65 points and a minimum of 13 points. The results of the analysis were evaluated as follows: ≥ 45 points, very good, 40-44 points good, 30-39 points moderate, 20-29 points poor, and a total score of ≤ 19 points.', 'armGroupLabels': ['Using Walker Group', 'Walker-Free Group']}, {'name': 'Physical activity level', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Physical Activity Questionnaire for Children (PAQ-C)'], 'description': 'This questionnaire, administered to children aged 4-14, evaluates the activities performed during a week. The questionnaire consisted of nine questions, each of which was evaluated on a 5 points. One point indicated a low physical activity level and five points indicated a high physical activity level. Dividing the total score of the selected items by the number of items gives a summary score for the PAQ-C questionnaire. In our study, we used the Turkish version of the questionnaire, which was found to be reliable and valid.', 'armGroupLabels': ['Using Walker Group', 'Walker-Free Group']}, {'name': 'Muscle strength', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Digital Muscle Strength Meter'], 'description': 'Our study objectively measured muscle strength using the JTech Commander PowerTrack Muscle Dynamometer.\n\nRight and left muscle tests: Hip flexors/hyperextensors/adductors/abductors/internal rotators/external retractors, knee flexors/extensors, and foot plantar flexors/dorsiflexors were evaluated. The measurement results were recorded in Newtons, the measurements were repeated three times, and the average of these three repetitions was recorded.', 'armGroupLabels': ['Using Walker Group', 'Walker-Free Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35575', 'city': 'Izmir', 'state': 'Karsıyaka', 'country': 'Turkey (Türkiye)', 'facility': 'Ege university faculty of health sciences', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'It can be requested within a period of two years from the year of publication of the work.', 'ipdSharing': 'YES', 'description': 'When deemed appropriate, data can be requested from the corresponding author via e-mail.', 'accessCriteria': 'If the data are necessary for the conduct or conclusion of another study, they may be requested from the author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ozden Gokcek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ozden Gokcek', 'investigatorAffiliation': 'Ege University'}}}}