Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT06667492
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Extremity Dynamometry Assessment in Neurotypical 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': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Peak Torque', 'timeFrame': 'Through study completion, an average of 5 months', 'description': 'Average Peak Torque refers to the average highest force output recorded during isometric contractions and represents the maximal strength generated by the muscle group being assessed (e.g., hip or knee flexors and extensors). Unit of Measure: Newton-metre (Nm)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dynamometry', 'lower limb', 'assessment', 'child'], 'conditions': ['Force Measurement', 'Children', 'Lower Limb', 'Assessment Tool']}, 'referencesModule': {'references': [{'pmid': '26397089', 'type': 'BACKGROUND', 'citation': 'Hebert LJ, Maltais DB, Lepage C, Saulnier J, Crete M. Hand-Held Dynamometry Isometric Torque Reference Values for Children and Adolescents. Pediatr Phys Ther. 2015 Winter;27(4):414-23. doi: 10.1097/PEP.0000000000000179.'}, {'pmid': '29802034', 'type': 'BACKGROUND', 'citation': 'Daloia LMT, Leonardi-Figueiredo MM, Martinez EZ, Mattiello-Sverzut AC. Isometric muscle strength in children and adolescents using Handheld dynamometry: reliability and normative data for the Brazilian population. Braz J Phys Ther. 2018 Nov-Dec;22(6):474-483. doi: 10.1016/j.bjpt.2018.04.006. Epub 2018 May 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the reliability (intra-rater and inter-rater) and criterion validity (using a Cybex isokinetic dynamometer as the reference) of the K-Pull (traction) dynamometer for evaluating lower limb function in children with neurotypical development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of typically developing children aged 5 to 16 years, selected based on specific inclusion and exclusion criteria to ensure the reliability and validity of traction dynamometry.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* typically developing children,\n* between the ages of 5 and 16 years,\n* have the capacity for voluntary motor control\n\nExclusion Criteria :\n\n* undergone any treatment or intervention that could impact neuromuscular performance, such as surgery or medication use,\n* experienced a recent injury\n* demonstrating low levels of compliance during assessments are not included in the study.'}, 'identificationModule': {'nctId': 'NCT06667492', 'briefTitle': 'Lower Extremity Dynamometry Assessment in Neurotypical Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Reliability and Validity of Lower Extremity Dynamometry Assessment in Neurotypical Children', 'orgStudyIdInfo': {'id': 'dynam-neurotyp-child'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuro-typical Children', 'description': 'Typically developing children aged 5 to 16 years with the ability of voluntary motor control are in included in the study.', 'interventionNames': ['Device: Traction Dynamometry']}], 'interventions': [{'name': 'Traction Dynamometry', 'type': 'DEVICE', 'description': 'K-Pull dynamometer (Model MP.09.02.FN, Kinvent, Montpellier, France) is an assessment tool used to quantify muscle strength. It uses traction through a non-elastic strap to facilitate isometric contractions. This instrument will be used to evaluate isometric activity (maximum and average torque values) of the hip and knee flexors and extensors at specific joint angles.', 'armGroupLabels': ['Neuro-typical Children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35132', 'city': 'Lamia', 'state': 'Phthiotis', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'George Paras, Ph.D.', 'role': 'CONTACT', 'email': 'gparas@uth.gr', 'phone': '2231060234', 'phoneExt': '+30'}], 'facility': 'Department of Physiotherapy - University of Thessaly', 'geoPoint': {'lat': 38.89947, 'lon': 22.4335}}], 'centralContacts': [{'name': 'George Paras, Ph.D.', 'role': 'CONTACT', 'email': 'gparas@uth.gr', 'phone': '2231060234', 'phoneExt': '+30'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'George Paras', 'investigatorAffiliation': 'University of Thessaly'}}}}