Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-02 @ 12:45 AM
Study NCT ID:
NCT06829056
Status:
COMPLETED
Last Update Posted:
2025-02-18
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presence of Pain Shows Greater Effect Than Tendon Structural Alignment During Landing Dynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tendon Structure', 'timeFrame': 'Baseline', 'description': "Ultrasound Tissue Characterization (UTC) captures tendon structure and quantifies the number of altered fibers. This technology classifies tendon structure into four echo types, reflecting tendon integrity and fibrillar organization. Data collection for the patellar tendon will be conducted with participants seated, hips and knees at 90° flexion, and feet supported on a stable surface. For the Achilles tendon, the participants will be lying down with ankle in neutral position. This positioning ensures the probe is aligned transversely to the tendons, enabling the acquisition of optimal ultrasound images without anisotropy. Ultrasound parameters will be standardized for all scans: a 40-second B-mode ultrasound using a 7-10 Hz linear transducer, with the probe attached to a tracking device that moves automatically along the tendon's perpendicular axis, capturing consecutive images at 0.2 mm intervals. A single scan of the tendons will be performed for each knee."}, {'measure': 'Jump Variables', 'timeFrame': 'baseline', 'description': 'The data collection protocol includes the following tasks: countermovement jump and tuck jump test. Kinematic variables will be analyzed by recording the spatial positions of reflective markers placed on specific anatomical regions. Data will be captured using the Qualisys Motion Capture System (version 2021.2). Ground reaction forces will be measured using a force platform connected to a signal amplifier. The platform records the three components of ground reaction forces-anteroposterior, mediolateral, and vertical-via four sensors. The image capture hardware is connected to the Qualisys USB Analog Acquisition interface, synchronizing temporal, kinetic, and kinematic data with the Qualisys Track Manager (QTM) software.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['jump performance', 'patellar tendon', 'tendon structure', 'UTC'], 'conditions': ['Patellar Tendon', 'Athletes']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to investigate the relationship between temporal, kinetic, and kinematic jump variables and patellar tendons' structure in athletes. The main research questions are:\n\nDoes the structure of the patellar tendon relate to the temporal, kinetic, and kinematic variables of different jumps?\n\nTo answer these questions, participants will undergo a UTC (Ultrasound Tissue Characterization) scan of the patellar tendon and perform two vertical jump: a countermovement jump and tuck jump test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population for this study consisted of volleyball athletes aged 18 to 35, of both sexes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 18-30 years;\n* competing in the highest-level Portuguese volleyball league with a minimum of 10 years of volleyball practice.\n\nExclusion Criteria:\n\n* presence of injuries or discomfort that impeded maximal jumping tests;\n* history of surgery within the last 12 months;\n* illness during data collection'}, 'identificationModule': {'nctId': 'NCT06829056', 'briefTitle': 'Presence of Pain Shows Greater Effect Than Tendon Structural Alignment During Landing Dynamics', 'organization': {'class': 'OTHER', 'fullName': 'Escola Superior de Tecnologia da Saúde do Porto'}, 'officialTitle': 'Presence of Pain Shows Greater Effect Than Tendon Structural Alignment During Landing Dynamics', 'orgStudyIdInfo': {'id': 'FIS-2022-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Athletes', 'description': 'Included volunteer participants were aged between 18-30 years, competing in the highest-level Portuguese volleyball league with a minimum of 10 years of volleyball practice. Participants were excluded in presence of injuries or discomfort that impeded maxi- mal jumping tests, history of surgery within the last 12 months or illness during data collection.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-072', 'city': 'Porto', 'state': 'Porto District', 'country': 'Portugal', 'facility': 'Escola Superior de Saúde do Instituto Politécnico do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Escola Superior de Tecnologia da Saúde do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree in Physiotherapy", 'investigatorFullName': 'Daniela Ferreira Carneiro', 'investigatorAffiliation': 'Escola Superior de Tecnologia da Saúde do Porto'}}}}