Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06667518
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lower Extremity Neuromuscular Assessment in Children with Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, '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': 'Muscle Strength', 'timeFrame': 'Through study completion, an average of 5 months', 'description': 'Average Peak Force 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 (N)'}, {'measure': 'Average Muscle Activation', 'timeFrame': 'Through study completion, an average of 5 months', 'description': 'Average activation in the context of surface electromyography refers to the mean level of electrical activity detected from muscle fibers over a specific period. Unit of Measure: millivolt (mV)'}], 'secondaryOutcomes': [{'measure': 'Muscle Tone', 'timeFrame': 'Through study completion, an average of 5 months', 'description': 'Evaluated using the Modified Ashworth Scale. Unit of Measure: Scoring Options (0-4) // (higher scores - worse outcome)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dynamometry', 'electromyography', 'cerebral palsy', 'child', 'lower limb'], 'conditions': ['Force Measurement', 'Electromyography', 'Children', 'Cerebral Palsy', 'Lower Limb']}, 'referencesModule': {'references': [{'pmid': '26744991', 'type': 'BACKGROUND', 'citation': 'Mulder-Brouwer AN, Rameckers EA, Bastiaenen CH. Lower Extremity Handheld Dynamometry Strength Measurement in Children With Cerebral Palsy. Pediatr Phys Ther. 2016 Summer;28(2):136-53. doi: 10.1097/PEP.0000000000000228.'}, {'pmid': '30207812', 'type': 'BACKGROUND', 'citation': 'Aertssen W, Smulders E, Smits-Engelsman B, Rameckers E. Functional strength measurement in cerebral palsy: feasibility, test-retest reliability, and construct validity. Dev Neurorehabil. 2019 Oct;22(7):453-461. doi: 10.1080/17518423.2018.1518963. Epub 2018 Sep 12.'}, {'pmid': '33362693', 'type': 'BACKGROUND', 'citation': 'Cappellini G, Sylos-Labini F, Assenza C, Libernini L, Morelli D, Lacquaniti F, Ivanenko Y. Clinical Relevance of State-of-the-Art Analysis of Surface Electromyography in Cerebral Palsy. Front Neurol. 2020 Dec 11;11:583296. doi: 10.3389/fneur.2020.583296. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the reliability (intra-rater and inter-rater) of the K-Pull dynamometer and the K-Myo non-invasive electromyography sensor (assessing neuromuscular activity) in the evaluation of the lower limbs in children with cerebral palsy.\n\nSpecific objectives include:\n\n* Examining differences in neuromuscular activity among children with CP classified at functional levels I to III on the GMFCS scale.\n* Deriving conclusions from the correlation between electromyographic activity, muscle tone, and generated muscle strength.\n* Assessing the applicability of neuromuscular activity assessment devices in clinical settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III based on specific inclusion and exclusion criteria to ensure the reliability and feasibility of traction dynamometry and surface electromyography assessment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with spastic type cerebral palsy (CP),\n* aged between 5 and 16 years,\n* classified at GMFCS levels I to III,\n* voluntary motor control,\n* ambulatory, with or without the use of mobility aids,\n* can understand and execute verbal commands.\n\nExclusion Criteria:\n\n* have previously undergone interventions that affect neuromuscular performance (such as surgery or botulinum toxin injections)\n* have sustained an injury,\n* demonstrate a low level of compliance.'}, 'identificationModule': {'nctId': 'NCT06667518', 'briefTitle': 'Lower Extremity Neuromuscular Assessment in Children with Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Reliability and Feasibility of Lower Extremity Dynamometry and Electromyography Assessment in Children with Cerebral Palsy', 'orgStudyIdInfo': {'id': 'neuromusc-cp-child'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with Cerebral Palsy', 'description': 'Children with cerebral palsy, aged 5 to 16 years, classified at GMFCS levels I to III.', 'interventionNames': ['Device: Neuromuscular Activity Assessment']}], 'interventions': [{'name': 'Neuromuscular Activity Assessment', 'type': 'DEVICE', 'description': "K-Pull dynamometer is an assessment tool used to quantify muscle strength. It uses traction through a non-elastic strap to facilitate isometric contractions.\n\nK-Myo (non-invasive EMG sensor) is an assessment tool used to detect muscle activation and tracking patient's improvement.", 'armGroupLabels': ['Children with Cerebral Palsy']}]}, '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': '22310 60234', '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': '22310 60234', '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'}}}}