Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT06501833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slalom dribble test', 'timeFrame': 'pre and immediately post intervention'}, {'measure': 'Harre circuit test', 'timeFrame': 'pre and immediately post intervention'}, {'measure': 'Loughborough soccer passing test', 'timeFrame': 'pre and immediately post intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Young Soccer Players']}, 'descriptionModule': {'briefSummary': "Background: Soccer is a prevalent sport worldwide; most soccer players are under 18. Soccer has benefits for your health, but there is also a chance that you could get injuries occasionally. High injury rates have been observed in both adult and young players, which has prompted the development of various preventive measures. FIFA recently introduced the FIFA 11+ Kids program for children under 14 to prevent soccer injuries and enhance kids' performance. To date, no studies have been done to determine whether adding the FIFA 11 + kids program for young players under 14 will enhance soccer-specific skills.\n\nObjective: To investigate the efficacy of FIFA 11+ Kids on soccer-specific skills among young soccer players.\n\nMethods: Thirty six young soccer players (aged 7-13) will be assigned randomly to the following groups: the control group (n =18) and the FIFA 11+ Kids program (n = 18). The experimental group will perform eight weeks of FIFA 11+ kids program (3/week). The control group will be instructed to continue their regular training . Three soccer specific skills tests : the Slalom dribble test, Harre circuit test, and Loughborough soccer passing test, will be done before and after eight weeks of training.\n\nStatistical analysis: IBM SPSS software (version 20) will be used for all statistical analyses. Data will be summarized in terms of mean and SD. Normality is checked with the Shapiro-Wilk test and homogeneity with Levene's tests. If the data are normally distributed, a paired t-test will be used for within-group difference comparison, and an independent t-test will be used for between-group comparison. If the data are not normally distributed, the Wilcoxon-Signed rank and Mann-Whitney U tests will be used."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria are\n\n1. Healthy male young soccer players between the ages of 7-13 (al Attar et al., 2022).\n2. Playing experience of at least one year.\n3. Participating in a training session at least three times per week (Teixeira et al., 2021).\n4. Participating in training at least 4.5 hours a week.\n\nThe exclusion criteria:\n\n1. Upper or lower limb injuries require medical attention within the last six months (al Attar et al., 2022).\n2. Any systemic disease, cardiovascular, neurological disorders, or surgery may affect the measurement and participation as reported by the participants (al-Attar et al., 2022).\n3. Any medication which may affect the training or measurement as reported by the participants.\n4. Any biomechanical abnormalities as reported by the participants.\n5. Missed two consecutive training sessions or three separate ones (Mirwald et al., 2002).\n6. Missing one of the testing sessions (Mirwald et al., 2002).\n\n \\-'}, 'identificationModule': {'nctId': 'NCT06501833', 'briefTitle': 'Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'Efficacy of FIFA 11+ Kids Injury Prevention Program on Soccer-specific Skills Among Young Soccer Players- A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-PGS-2023-03-254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FIFA 11+ kids program group', 'interventionNames': ['Other: FIFA 11+ KIDS PROGRAM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular training group', 'interventionNames': ['Other: REGULAR TRAINING']}], 'interventions': [{'name': 'FIFA 11+ KIDS PROGRAM', 'type': 'OTHER', 'description': 'The experimental group will perform eight weeks of FIFA 11+ kids program (3/week).', 'armGroupLabels': ['FIFA 11+ kids program group']}, {'name': 'REGULAR TRAINING', 'type': 'OTHER', 'description': 'The control group will be continuing their regular training', 'armGroupLabels': ['Regular training group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Shibili Nuhmani', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}