Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-29 @ 10:50 PM
Study NCT ID:
NCT06551532
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2024-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Ecological Program Changes Pelvic Kinematics in Soccer Players: Pilot Study on Hamstring Injury Implications"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'In this study, both participants and researchers are aware of the group assignment. Participants know whether they are receiving the multicomponent intervention or are part of the control group. The researchers who administer the intervention and collect data are also aware of the group assignments.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to either an intervention group receiving the multicomponent intervention or a control group with no intervention, with both groups being monitored concurrently throughout the 6-week period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior Pelvic Tilt (APT) Reduction.', 'timeFrame': 'Baseline (PRE) and immediately after 6 weeks of intervention (POST).', 'description': 'The primary outcome measure is the reduction in static anterior pelvic tilt (APT) immediately after 6 weeks of the multicomponent intervention. APT is measured using a three-dimensional kinematic analysis during static and high-speed running tasks. The reduction in APT will be assessed before (PRE) and immediately after (POST) the intervention period to determine the effectiveness of the intervention in modifying pelvic alignment.'}], 'secondaryOutcomes': [{'measure': 'biomechanical variables during high-speed running (HSR) and high-speed soccer running (HSSR) tasks', 'timeFrame': 'Baseline (PRE) and immediately after 6 weeks of intervention (POST).', 'description': '"This outcome measure assesses changes in specific biomechanical variables, including segment orientations (trunk, pelvis, femur, and tibia) relative to the sagittal plane, and joint angles (hip flexion and knee flexion) during high-speed running (HSR) and high-speed soccer running (HSSR) tasks. The study aims to evaluate the shift towards a more front-side oriented sprint technique model and the associated improvements in sprint performance time. Measurements will be taken using three-dimensional motion capture analysis to quantify the kinematic changes during HSR and HSSR."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hamstring strain', 'Muscle Injury', 'Pelvic Tilt', 'Sprint Kinematics', 'Sprint Mechanics'], 'conditions': ['Anterior Pelvic Tilt', 'Sprint Kinematics']}, 'descriptionModule': {'briefSummary': 'The present pilot study aimed to investigate whether a 6-week multicomponent intervention, comprising a structural lumbopelvic and sprint technique program, could reduce anterior pelvic tilt in soccer players who regularly participated in soccer practice.', 'detailedDescription': 'This pilot study aimed to evaluate the impact of a 6-week multicomponent intervention combining lumbopelvic control exercises and running technique training on pelvis structure and lower limb kinematics in semi-professional soccer players. Seventeen players were randomly assigned to a control group (CG) or an intervention group (IG). Data on static anterior pelvic tilt (APT) and three-dimensional kinematics during high-speed running (HSR) and high-speed soccer running (HSSR) were collected before (PRE) and after (POST) the intervention period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria for both groups were: (a) being between 18 and 40 years old, and (b) being available for their teams\n\nExclusion Criteria:\n\n* Exclusion criteria for both groups included (a) not having suffered any musculoskeletal injuries in the previous 3 months and (b) not being involved in any additional strength program outside of their regular team training.'}, 'identificationModule': {'nctId': 'NCT06551532', 'briefTitle': '"Ecological Program Changes Pelvic Kinematics in Soccer Players: Pilot Study on Hamstring Injury Implications"', 'organization': {'class': 'OTHER', 'fullName': 'RX2 Sports and Health'}, 'officialTitle': 'An In-season Ecological Program Performed by Soccer Players Changes Pelvic Kinematics During Static, Linear Sprinting and Sport-specific Tasks: a Pilot Study on the Implication for Hamstring Injuries.', 'orgStudyIdInfo': {'id': 'RX2_EstudioHamstring_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multicomponent Intervention Group', 'description': 'Soccer players in the intervention group (IG) underwent a multimodal training program comprising 3 sessions per week for 6 weeks. All the soccer players in IG were allowed to continue their usual training (5 sessions per week) and matches (1 per week) at their clubs. The training program comprised both lumbopelvic training (foam rolling, manual therapy, mobility, posture, and strength training) and sprint technique components. The intervention included a total of 18 sessions of approximately 50 minutes each and sessions were supervised by 2 physiotherapists. During the 6 weeks of the intervention, participants performed the multicomponent program 3 times a week. Monday, Wednesday, and Friday were the chosen days for carrying out the training program, as Sunday was usually a game day.', 'interventionNames': ['Other: Multicomponent program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Soccer players in the control group (CG) were requested not to modify their established training routines during the entire 6-week period.'}], 'interventions': [{'name': 'Multicomponent program', 'type': 'OTHER', 'description': 'Lumbopelvic training (foam rolling, manual therapy, mobility, posture, and strength training) and sprint technique program.', 'armGroupLabels': ['Multicomponent Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28223', 'city': 'Madrid', 'country': 'Spain', 'facility': 'RX2 Sports and Health', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RX2 Sports and Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator and PhD Candidate.', 'investigatorFullName': 'Andrea Astrella', 'investigatorAffiliation': 'RX2 Sports and Health'}}}}