Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:16 AM
Study NCT ID:
NCT07417332
Status:
COMPLETED
Last Update Posted:
2026-02-20
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of the Degree of Dynamic Stability of the Foot in Single-leg Support in Relation to the Foot Posture Index in Judokas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-26', 'size': 701151, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-11T10:50', 'hasProtocol': True}, {'date': '2023-01-26', 'size': 91960, 'label': 'Informed Consent Form: Child Assent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-11T07:33', 'hasProtocol': False}, {'date': '2023-01-26', 'size': 114766, 'label': 'Informed Consent Form: Adult Participants', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-11T07:29', 'hasProtocol': False}, {'date': '2023-01-26', 'size': 110602, 'label': 'Informed Consent Form: Parental Consent for Minors', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-11T07:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic postural stability score (Y Balance Test) normalized by limb length', 'timeFrame': 'Single assessment at baseline (one testing session)', 'description': 'Dynamic postural stability will be assessed using the Y Balance Test (YBT). Participants stand on one leg at the center of a Y-shaped grid and reach in three directions (anterior, posteromedial, and posterolateral) with the contralateral leg. Three valid trials will be recorded for each leg after familiarization. For each direction, the mean of the three reach distances (in centimeters) will be calculated and then normalized to limb length (distance from anterior superior iliac spine to distal tibial malleolus) to obtain a percentage score. A composite YBT score will be derived by summing the three normalized reach distances and dividing by three. Higher scores indicate better dynamic postural stability.'}], 'secondaryOutcomes': [{'measure': 'Difference in dynamic stability between foot posture groups (pronated, neutral, supinated)', 'timeFrame': 'Single assessment at baseline', 'description': 'Participants will be classified into three groups according to their Foot Posture Index (FPI-6) scores: pronated, neutral, and supinated feet. The primary Y Balance Test (YBT) composite score, expressed as a percentage, will be compared between these three foot posture groups to determine whether foot type is associated with differences in dynamic postural stability. The YBT composite score is a percentage scale (theoretical range from 0 to values \\>100), where higher scores indicate better dynamic postural stability.'}, {'measure': 'Association between dynamic stability and history of lower limb or spine injuries', 'timeFrame': 'Single assessment at baseline', 'description': 'Participants will report their history of injuries to the neck, spine, hip, or lower limb using a standardized questionnaire. The normalized composite Y Balance Test score will be compared between judokas with and without a history of such injuries to evaluate whether previous injury is associated with differences in dynamic postural stability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Judo', 'Foot Posture Index (FPI-6)', 'Dynamic Stability', 'Postural Balance', 'Y Balance Test', 'Lower Limb Biomechanics', 'Single-Leg Support', 'Sports Injury Risk', 'Athletic Performance', 'Martial Arts'], 'conditions': ['Postural Balance', 'Foot Posture', 'Sports Injuries', 'Athletic Performance']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Parada-Souto JC, Part-Ferrer R, Jaenada-Carrilero E, Sales Castellanos C, Gallego-Estévez R. Determination of the degree of dynamic stability of the foot in single-leg support in relation to the Foot Posture Index in judokas. Manuscript submitted for publication.'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to examine the relationship between foot type and dynamic stability (balance while standing on one leg) in judo athletes. Judo requires excellent balance to perform techniques effectively and avoid injuries. However, there is limited scientific knowledge about how foot posture affects balance in judokas.\n\nThe main questions this study aims to answer are:\n\n* Does foot type (neutral, pronated, or supinated) affect dynamic stability in judokas?\n* Are there differences in balance between male and female judokas?\n* Does injury history affect dynamic stability?\n* Is there a difference in balance between the dominant and non-dominant foot?\n\nParticipants in this study will:\n\n* Have their foot type assessed using the Foot Posture Index (FPI-6), a clinical tool that evaluates foot alignment\n* Perform the Y Balance Test, which measures how far they can reach in three directions while standing on one leg\n* Complete a questionnaire about their training history, injuries, and demographic information\n\nAll assessments will be conducted in the participants' judo training facilities (tatami) during a single session.\n\nResearchers will compare three groups of judokas (those with neutral, pronated, and supinated feet) to see if foot type influences balance performance. This information may help coaches and healthcare professionals better assess athletes, prevent injuries, and improve sports performance in judo.", 'detailedDescription': "Judo is a combat sport that places high demands on dynamic postural control due to continuous changes in stance, center of mass, and base of support during throws, defenses, and transitions between standing and ground fighting. Alterations in foot posture (neutral, pronated, or supinated) may modify lower limb biomechanics and could influence dynamic stability and injury risk, but this relationship has not been specifically examined in adult judokas.\n\nThis cross-sectional observational study was conducted in federated judokas from clubs in the Galician provinces of A Coruña and Pontevedra (Spain). A total of 45 athletes were classified into three groups according to the Foot Posture Index (FPI-6): pronated, neutral, and supinated feet. Dynamic postural stability was assessed using the Y Balance Test (YBT), normalized to limb length to obtain a composite percentage score for each lower limb. Additional variables included age, sex, training exposure, years practicing judo, dominant (habitual support) foot, and history of neck, spine, hip, or lower limb injuries.\n\nThe primary objective is to determine whether dynamic stability differs between foot posture groups. Secondary objectives are to: (1) explore associations between stability and sociodemographic/training variables, (2) examine differences in YBT scores between judokas with and without a history of lower limb or spine injuries, and (3) compare stability between the dominant and non-dominant foot in single-leg techniques. Statistical analyses include descriptive statistics, normality testing, one-way ANOVA with appropriate post-hoc tests for group comparisons, and Student's t-tests for bivariate analyses, with a two-sided significance level of p \\< 0.05.\n\nThe findings are expected to clarify whether specific foot morphologies are associated with reduced dynamic stability in judokas, providing clinically useful information for biomechanical assessment, targeted injury prevention, and performance optimization in this population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Federated judo athletes aged 15 to 40 years from judo clubs in the Galician provinces of A Coruña and Pontevedra (Spain), with at least 3 years of practice and regular weekly training.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Federated judo athletes between 15 and 40 years of age.\n* Minimum of 3 years practicing judo.\n* At least 2 judo training sessions per week.\n* Ability to understand and follow study instructions.\n* Signed informed consent (and parental consent for minors, if applicable).\n\nExclusion Criteria:\n\n* Presence of any systemic disease that may cause morphological or biomechanical alterations of the lower limbs.\n* Current biomechanical limitations of the lower limbs that prevent safe performance of the Y Balance Test.\n* History of recent lower limb surgery or spinal surgery that may interfere with balance assessment.\n* Refusal to undergo measurements or to have data collected at the time of evaluation.'}, 'identificationModule': {'nctId': 'NCT07417332', 'briefTitle': 'Determination of the Degree of Dynamic Stability of the Foot in Single-leg Support in Relation to the Foot Posture Index in Judokas', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Universidad Católica de Valencia San Vicente Mártir'}, 'officialTitle': 'Determination of the Degree of Dynamic Stability of the Foot in Single-leg Support in Relation to the Foot Posture Index in Judokas', 'orgStudyIdInfo': {'id': 'UCV/2022-2023/111'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Judo Athletes', 'description': 'Federated judo athletes aged 15 to 40 years from clubs in A Coruña and Pontevedra, Spain. All participants undergo assessment of foot posture using the Foot Posture Index (FPI-6) and dynamic postural stability using the Y Balance Test in a single evaluation session.', 'interventionNames': ['Other: Postural and Balance Assessment']}], 'interventions': [{'name': 'Postural and Balance Assessment', 'type': 'OTHER', 'description': 'Non-invasive assessment of foot posture using the Foot Posture Index (FPI-6) and dynamic balance using the Y Balance Test performed once in each participant.', 'armGroupLabels': ['Judo Athletes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46001', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Catholic University of Valencia San Vicente Mártir', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Luis Baraja Vegas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of Valencia San Vicente Mártir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Universidad Católica de Valencia San Vicente Mártir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD', 'investigatorFullName': 'Luis Baraja Vegas', 'investigatorAffiliation': 'Fundación Universidad Católica de Valencia San Vicente Mártir'}}}}