Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT07072260
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Activator-Assisted Talocrural Manipulation on Performance in Elite Volleyball Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single Blind (Statistician analyzing data was blinded)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle Range of Motion (Plantar/Dorsiflexion)', 'timeFrame': 'Pre-intervention (T0) and post-intervention (T1, within 3-5 minutes).', 'description': 'Plantar and dorsiflexion measured using a goniometer (degrees).'}, {'measure': 'Y-Balance Test', 'timeFrame': 'Pre-intervention (T0) and post-intervention (T1, within 3-5 minutes).', 'description': 'Anterior, posteromedial, and posterolateral reach distances (cm).'}, {'measure': 'Jumping Performance:', 'timeFrame': 'Pre-intervention (T0) and post-intervention (T1, within 3-5 minutes).', 'description': 'Vertical jump height and horizontal jump distance (cm).'}, {'measure': 'Dynamic Weight Transfer', 'timeFrame': 'Pre-intervention (T0) and post-intervention (T1, within 3-5 minutes).', 'description': 'Assessed via pedobarographic analysis, including static load ratio (%), dynamic contact area ratio (CAR-AP, CAR-RP, %), and dynamic speed (mm/s).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Joint Manipulation', 'Range of Motion', 'Athletic Performance', 'Sports', 'Balance', 'Jumping Performance', 'Physical Therapy Modalities', 'Postural Balance', 'Motor Activity', 'Volleyball']}, 'referencesModule': {'references': [{'pmid': '41053891', 'type': 'DERIVED', 'citation': 'Haksever B, Hajighorbani K, Cakir CH, Isguzar MG, Elbasan B. Investigation of the effect of activator-assisted talocrural joint manipulation on acute sports performance parameters in elite male volleyball players. BMC Sports Sci Med Rehabil. 2025 Oct 7;17(1):291. doi: 10.1186/s13102-025-01358-1.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the acute effects of activator-assisted talocrural joint manipulation on joint range of motion, dynamic balance, vertical and horizontal jump performance, and weight transfer parameters in elite male volleyball players aged 18-25. The study compares a manipulation group with a sham control group and assesses performance metrics before and after the intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Elite male volleyball players aged 15-25 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elite male volleyball players aged 15-25 years\n* Minimum of 3 years of professional volleyball training experience\n* Active member of a team and club\n\nExclusion Criteria:\n\n* Not actively participating in training or matches\n* History of acute musculoskeletal pathology or surgery in the lower extremities'}, 'identificationModule': {'nctId': 'NCT07072260', 'briefTitle': 'Effect of Activator-Assisted Talocrural Manipulation on Performance in Elite Volleyball Players', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Investigation of the Effect of Activator-Assisted Talocrural Joint Manipulation on Acute Sports Performance Parameters in Elite Male Volleyball Players', 'orgStudyIdInfo': {'id': '2025/047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Activator-Assisted Talocrural Manipulation', 'description': 'Participants in this group receive a single session of activator-assisted manipulation using the Activator Adjustment Instrument (AAI) to the talocrural (ankle) joint. Six impulses (three anterior and three posterior) are applied with the ankle in a neutral position.', 'interventionNames': ['Other: Activator Manipulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Soft Tissue Stroking', 'description': 'Participants in this group receive a sham intervention consisting of light soft tissue stroking around the talocrural joint without joint manipulation. The application mimics the duration and setup of the experimental group but does not include any mechanical stimulus.', 'interventionNames': ['Other: Sham Stroking']}], 'interventions': [{'name': 'Sham Stroking', 'type': 'OTHER', 'otherNames': ['Non-therapeutic light touch technique'], 'description': 'Participants in this group receive a sham intervention consisting of light soft tissue stroking around the talocrural joint without joint manipulation. The application mimics the duration and setup of the experimental group but does not include any mechanical stimulus.', 'armGroupLabels': ['Sham Soft Tissue Stroking']}, {'name': 'Activator Manipulation', 'type': 'OTHER', 'otherNames': ['Activator Adjustment Instrument (AAI)'], 'description': 'Participants in this group receive a single session of activator-assisted manipulation using the Activator Adjustment Instrument (AAI) to the talocrural (ankle) joint. Six impulses (three anterior and three posterior) are applied with the ankle in a neutral position.', 'armGroupLabels': ['Activator-Assisted Talocrural Manipulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to privacy concerns and institutional data protection policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}