Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT06053632
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Young Age Soccer Player's Lower Limb Muscle Imbalance and Functional Status
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in isokinetic peak torque (with Biodex)', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'Knee extension/flexion isokinetic peak torque measurements will be done at 60°/s, 120°/s'}, {'measure': 'Dynamic balance', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'Y-balance Test evaluates lower extremity strength, knee stability and dynamic balance in anterior, posteromedial and posterolateral direction. For each direction, three practice trials were allowed before three test trials were recorded. Mean reach distances (cm) was normalized to leg length, which was measured from the anterior superior iliac spine to the most distal portion of the medial malleolus.'}, {'measure': 'Changes in muscle contractile characteristics (with tensiomyography (TMG))', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'Muscle involuntary contractile characteristics of the lower-limb muscles-the rectus femoris (RF), vastus medialis (VM), vastus lateralis (VL), biceps femoris (BF), semitendinosus (ST), tibialis anterior (TA), gastrocnemius medialis (GM) and gastrocnemius lateralis (GL)-will be recorded by measuring the response of these muscles to an induced electric stimulus (provoked by two self-adhesive electrodes) using TMG equipment on both the left and right lower extremities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young age soccer player', 'Eccentric hamstring exercise', 'Dynamic balance', 'Contractile muscle properties'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial is designed to examine the effects of low-load and high-velocity eccentric exercises on lower limb muscular properties, imbalances and functional status of 13-15 years old female football players.', 'detailedDescription': 'Twenty participants were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=10) participants after team soccer training additional received 4 weeks eccentric exercises, in the control group (n=10) - did not perform additional exercises. The research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. Pre- and post- training assessment included concentric/eccentric knee extension and flexion at 60°/s and 120°/s, changes in muscle contractile characteristics and dynamic balance.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy players able to participate in training and competitions.\n* Playing football for at least 2 years.\n* Regularly participating in team training, 2-3 times a week.\n\nExclusion Criteria:\n\n* Female soccer players with a lower extremity injury (in a period of 6 months)\n* Pain is less than 2 points on the Visual Analog Pain Scale.\n* Irregular exercise\n* The number of years of training attended is too low'}, 'identificationModule': {'nctId': 'NCT06053632', 'briefTitle': "Young Age Soccer Player's Lower Limb Muscle Imbalance and Functional Status", 'organization': {'class': 'OTHER', 'fullName': 'Lithuanian Sports University'}, 'officialTitle': 'The Effect of Eccentric Exercises on Lower Limb Muscle Imbalances and Functional Status of Young Female Football Players', 'orgStudyIdInfo': {'id': 'LithuananianSportsU-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group will be asked to maintain their usual lifestyle.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'The research group performed additional low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks. 12 sessions in total.', 'interventionNames': ['Behavioral: Low-load and high-velocity - lying prone - eccentric hamstring exercise']}], 'interventions': [{'name': 'Low-load and high-velocity - lying prone - eccentric hamstring exercise', 'type': 'BEHAVIORAL', 'description': 'Low-load and high-velocity - lying prone - eccentric hamstring exercise 3 times per week for 4 weeks.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44221', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Lithuanian Sports University', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}], 'overallOfficials': [{'name': 'Dovile Kiele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lithuanian Sports University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lithuanian Sports University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}