Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT06459258
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012783', 'term': 'Shoulder Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study group allocation is performed in a randomized and examiner-blinded fashion.\n\nAll study authors and examiners are blinded to the group allocation until completion of data analysis.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Throwing velocity (km*h-1)', 'timeFrame': 'Baseline to 6-week post-intervention follow-up.', 'description': 'the difference in throwing velocity (km\\*h-1) from baseline to 6-week post-intervention follow-up.'}], 'secondaryOutcomes': [{'measure': 'Isometric hand-held dynamometer (HHD) ER and internal rotation (IR) maximal shoulder strength', 'timeFrame': 'Baseline to 6-week post-intervention follow-up', 'description': 'Secondary outcome was the difference in isometric hand-held dynamometer (HHD) ER and internal rotation (IR) maximal shoulder strength at final follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motion-Triggered Neuromuscular Electrical Stimulation-Enhanced Strength Training'], 'conditions': ['Shoulder Dislocation']}, 'referencesModule': {'references': [{'pmid': '37870503', 'type': 'RESULT', 'citation': 'Moroder P, Karpinski K, Akgun D, Danzinger V, Gerhardt C, Patzer T, Tauber M, Wellmann M, Scheibel M, Boileau P, Lambert S, Porcellini G, Audige L. Neuromuscular Electrical Stimulation-Enhanced Physical Therapist Intervention for Functional Posterior Shoulder Instability (Type B1): A Multicenter Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad145. doi: 10.1093/ptj/pzad145.'}, {'pmid': '31378683', 'type': 'RESULT', 'citation': 'Moroder P, Danzinger V, Maziak N, Plachel F, Pauly S, Scheibel M, Minkus M. Characteristics of functional shoulder instability. J Shoulder Elbow Surg. 2020 Jan;29(1):68-78. doi: 10.1016/j.jse.2019.05.025. Epub 2019 Aug 1.'}, {'pmid': '32667266', 'type': 'RESULT', 'citation': 'Moroder P, Plachel F, Van-Vliet H, Adamczewski C, Danzinger V. Shoulder-Pacemaker Treatment Concept for Posterior Positional Functional Shoulder Instability: A Prospective Clinical Trial. Am J Sports Med. 2020 Jul;48(9):2097-2104. doi: 10.1177/0363546520933841.'}]}, 'descriptionModule': {'briefSummary': 'The successful application of treatment protocols using motion-triggered neuromuscular electrical stimulation (NMES) for treatment-resistant functional posterior shoulder instability was recently demonstrated. The purpose of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players.', 'detailedDescription': 'The aim of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players. It is hypothesized that a 6-week motion-triggered NMES shoulder strengthening training protocol in elite-level handball players would lead to an increase in throwing velocity due to an improved motor ability and ER shoulder strength.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elite level handball players healthy and actively competing at the time of the study\n* Patients must be at least 18 years at the time of signing the informed consent\n* Pregnancy must be ruled out in the case of female participants (e.g., pregnancy test)\n* Patient must be available for all specified assessments throughout the study duration\n* All patients are required to give written informed consent before enrollment\n\nExclusion Criteria:\n\n* age \\<18,\n* history of type I or II shoulder instability according to the Stanmore classification12,\n* existing pain syndrome (defined by pain at rest or during motion that is not caused by dislocation and impedes training),\n* recent shoulder surgery (\\<1 year).\n* Contraindication to SPM treatment (e.g., cardiac pacemaker)\n* Neurological disorders or nerve injuries causing the instability\n* Uncontrolled alcohol or substance abuse'}, 'identificationModule': {'nctId': 'NCT06459258', 'briefTitle': 'Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training', 'organization': {'class': 'OTHER', 'fullName': 'Sportorthopädie Zentrum in Wien Hietzing'}, 'officialTitle': 'Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training', 'orgStudyIdInfo': {'id': 'EK22-201-1022'}, 'secondaryIdInfos': [{'id': 'EK22-201-1022', 'type': 'OTHER', 'domain': 'Ethics Committee Vienna'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-NMES control group', 'description': 'Subjects of the control group undergo a conventional standardized strength training program (3x/week, 30 minutes for 6 weeks) with concentric, eccentric, and functional training exercises.', 'interventionNames': ['Other: Non-Motion-triggered NMES training protocol']}, {'type': 'EXPERIMENTAL', 'label': 'NMES group', 'description': "Experimental group subjects undergo a motion-triggered NMES shoulder strengthening training program (3x/week, 30 minutes for 6 weeks) using the Shoulder Pacemaker (NCS Lab Srl, Modena, Italy), a motion activated stimulation device to strengthen muscular disbalances. This is accomplished through varying neuromuscular electrical stimulation intensity based on the angle of motion of the arm producing subtetanic contraction and provoking supraspinal neural adaptations.\n\nElectrode placement: electrode 1, inferior to the scapular spine (infraspinatus, teres minor, + posterior deltoid); electrode 2, medial to the medial scapula border (lower trapezius + rhomboids) .\n\nSets x repetitions: 3x20; Levels: Level 1-3; Exercise 1: L1: Supported row, L2: Front raises in 45°, L3 Front raises (thumbs up); Exercise 2: L1: Resisted front raises, L2: Crossbody resisted raises, L3: Crossbody 'forehand swing'; Exercise 3: L1: Rear dealt fly, L2: Single arm resisted row, L3: Underhand serve", 'interventionNames': ['Other: Motion-triggered NMES training protocol']}], 'interventions': [{'name': 'Motion-triggered NMES training protocol', 'type': 'OTHER', 'description': 'Experimental group subjects undergo a motion-triggered NMES shoulder strengthening training program (3x/week, 30 minutes for 6 weeks) using the Shoulder Pacemaker (NCS Lab Srl, Modena, Italy), a motion activated stimulation device to strengthen muscular disbalances. This is accomplished through varying neuromuscular electrical stimulation intensity based on the angle of motion of the arm producing subtetanic contraction and provoking supraspinal neural adaptations. Electrode placement: electrode 1, inferior to the scapular spine (infraspinatus, teres minor, + posterior deltoid); electrode 2, medial to the medial scapula border (lower trapezius + rhomboids) . Sets x repetitions: 3x20 Levels: Level 1-3; Exercise 1: L1: Supported row, L2: Front raises in 45°, L3 Front raises (thumbs up) Exercise 2: L1: Resisted front raises, L2: Crossbody resisted raises, L3: Crossbody; forehand swing; Exercise 3: L1: Rear dealt fly, L2: Single arm resisted row, L3: Underhand volleyball', 'armGroupLabels': ['NMES group']}, {'name': 'Non-Motion-triggered NMES training protocol', 'type': 'OTHER', 'description': 'Arm Description: Subjects of the control group undergo a conventional standardized strength training program (3x/week, 30 minutes for 6 weeks) with concentric, eccentric, and functional training exercises.', 'armGroupLabels': ['Non-NMES control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11190', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Sportorthopädie Zentrum', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sportorthopädie Zentrum in Wien Hietzing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Austrian Research Group for Regenerative and Orthopedic Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sebastian Rilk', 'investigatorAffiliation': 'Sportorthopädie Zentrum in Wien Hietzing'}}}}