Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-02 @ 3:31 AM
Study NCT ID:
NCT06747104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Manual Therapy to Archers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of MVC.', 'timeFrame': 'Each isometric muscle test lasts 3 seconds. The study is performed three times for each muscle.', 'description': 'Muscle EMG is an assessment of the electrical characteristics during the study, the electrical source of which is the muscle membrane potential, and the measured EMG potentials are measured in μV and the repetition rate of muscle motor unit firing measured in Hz, at the same time of the study.'}, {'measure': 'Muscle stiffness', 'timeFrame': 'Each Myoton application lasts 1 sec for one point. Three evaluations of one of the two points for one muscle are performed. It is assumed that the study with recording will last 30 seconds for one muscle.', 'description': 'Muscle stiffness - characteristic resistance to physical contraction, which deforms initially forming. Stiffness (N/m) was calculated as S = amax.mprobe/Δl.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['archery', 'muscle fatigue', 'recovery', 'manipulation'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to: (i) characterize the effect of repeated archery shots on the EMG parameters of certain selected upper limb muscles; and (ii) evaluate how manipulation of the initial two-second tension phase, in particular involving muscle stretching, affects these EMG parameters after repeated shots.', 'detailedDescription': 'EMG measurements will be collected for selected muscles in the shoulder joint and forearm, at points: initially at the beginning, after the athletes have performed 50 and another 50 archery shots, and finally after undergoing manual therapy. The main phase of muscle testing will take place in the Aiming phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Actively training as an archer at least twice a week for six months;\n* In good health, with no recent injury or illness;\n* Over 18 years of age;\n* Engagement in all phases of the study.\n\nExclusion Criteria:\n\n* Any injury or illness present at the time of the study;\n* Recent history (within six months) of upper extremity injury (shoulder, elbow, or wrist), joint pain, lower extremity joint hypermobility, or neurological/connective tissue disease.\n* No training participation\n* No consent for study'}, 'identificationModule': {'nctId': 'NCT06747104', 'briefTitle': 'Application of Manual Therapy to Archers', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'Assessment of Upper Limb Muscle Activity and the Effect of Manual Therapy on Fatigue, Stiffness and Muscle Activity During Training', 'orgStudyIdInfo': {'id': 'KB/750/2023-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Assessment of acute effects of manipulation and muscle strength', 'description': 'Performing the manipulation with a preliminary two-second tension of the joint capsule in the shoulder and elbow joints.', 'interventionNames': ['Other: Manual therapy', 'Other: Placebo']}], 'interventions': [{'name': 'Manual therapy', 'type': 'OTHER', 'description': 'This technique involves a low-amplitude, high-velocity push on the shoulder and elbow joints with an additional two-second tension', 'armGroupLabels': ['Assessment of acute effects of manipulation and muscle strength']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Performing manipulations without a two-second preliminary tension of the joint capsule in the shoulder and elbow joints.', 'armGroupLabels': ['Assessment of acute effects of manipulation and muscle strength']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rafał Studnicki, PhD', 'role': 'CONTACT', 'email': 'fizjoterapia@gumed.edu.pl', 'phone': '+48583491509'}], 'overallOfficials': [{'name': 'Rafał Studnicki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Gdansk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Once the study is complete, the results will be sent to the researcher who will analyze the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}