Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 12:44 PM
Study NCT ID:
NCT04868006
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2021-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
End-range Maitland Mobilization on Glenohumeral Internal Rotation Deficit and Proprioception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-04', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Internal rotation of the dominant glenohumeral joint', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of active internal rotation of the dominant glenohumeral joint with goniometer expressed in degree'}], 'secondaryOutcomes': [{'measure': 'Flexion of the dominant glenohumeral joint', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of active flexion of the dominant glenohumeral joint with goniometer expressed in degree'}, {'measure': 'Extension of the dominant glenohumeral joint', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of active extension of the dominant glenohumeral joint with goniometer expressed in degree'}, {'measure': 'Abduction of the dominant glenohumeral joint', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of active abduction of the dominant glenohumeral joint with goniometer expressed in degree'}, {'measure': 'Adduction of the dominant glenohumeral joint', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of active adduction of the dominant glenohumeral joint with goniometer expressed in degree'}, {'measure': 'External rotation of the dominant glenohumeral joint', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of active external rotation of the dominant glenohumeral joint with goniometer expressed in degree'}, {'measure': 'Western Ontario Shoulder Instability Index', 'timeFrame': 'after 8 weeks', 'description': 'Western Ontario Shoulder Instability Index of the dominant shoulder'}, {'measure': 'Posterior Shoulder Endurance Test', 'timeFrame': 'after 8 weeks', 'description': 'Muscle strength test of the dominant shoulder expressed in Newton'}, {'measure': 'Proprioception of the shoulder', 'timeFrame': 'after 8 weeks', 'description': 'Proprioception of the shoulder measured with plurimeter expressed in degree'}, {'measure': 'Davies test', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of proprioception and muscle strength test by the Davies test expressed in amount of success touch'}, {'measure': 'Sportspecific proprioception test', 'timeFrame': 'after 8 weeks', 'description': 'Measurement of the precision of serving expressed in centimeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Musculoskeletal Manipulations', 'Range Of Motion, Articular', 'Proprioception', 'Volleyball'], 'conditions': ['Sports Physical Therapy']}, 'referencesModule': {'references': [{'pmid': '32789249', 'type': 'RESULT', 'citation': 'Miura K, Tsuda E, Ishibashi Y. Glenohumeral Rotational Deficit and Suprascapular Neuropathy in the Hitting Shoulder in Male Collegiate Volleyball Players. Prog Rehabil Med. 2019 Jan 12;4:20190002. doi: 10.2490/prm.20190002. eCollection 2019.'}, {'pmid': '23015864', 'type': 'RESULT', 'citation': 'Wilk KE, Reinold MM, Macrina LC, Porterfield R, Devine KM, Suarez K, Andrews JR. Glenohumeral internal rotation measurements differ depending on stabilization techniques. Sports Health. 2009 Mar;1(2):131-6. doi: 10.1177/1941738108331201.'}]}, 'descriptionModule': {'briefSummary': 'Glenohumeral internal rotation deficit (GIRD) is one of the main reasons for glenohumeral pain in athletes with over-head activity. As GIRD increases, the ratio between internal and external rotation changes resulting in decreased joint stability.\n\nJoint mobilization is a possible option for the decrease of GIRD and contribution to improvement of proprioception in addition to physical therapy. The aim of this trial is to investigate the effect of end-range Maitland mobilization in addition to physical therapy on GIRD, other joint movements and proprioception.', 'detailedDescription': 'Glenohumeral internal rotation deficit (GIRD) is one of the main reasons for glenohumeral pain in athletes with over-head activity. As GIRD increases, the ratio between internal and external rotation changes resulting in decreased joint stability. The occurence of GIRD and decreased joint proprioception may lead to different shoulder pathologies (e.g. Impingement syndrome).\n\nJoint mobilization is a possible option for the decrease of GIRD and contribution to improvement of proprioception in addition to physical therapy. Several joint mobilization techniques exists, which can be applied for stretching of periarticular tissues. Maitland mobilization is a well applied mobilization type. The effectiveness of both end-range and not end-range Maitland mobilization in lengthening of periarticular tissues and improvement of joint proprioception has been previously confirmed amongst several diseases. However, the effect of end-range Maitland mobilization on decrease of GIRD and proprioception in addition to physical therapy has not been investigated in volleyball players so far.\n\nThe aim of this trial is to investigate the effect of end-range Maitland mobilization in addition to physical therapy on GIRD, other joint movements and proprioception.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* National Championship players in I. or II. level\n* at least, 10 degree deficit of glenohumeral internal rotation in the dominant shoulder compared to the non-dominant hand\n\nExclusion Criteria:\n\n* previous trauma or surgery on the dominant shoulder\n* participation in any kind of treatment during the intervention period'}, 'identificationModule': {'nctId': 'NCT04868006', 'briefTitle': 'End-range Maitland Mobilization on Glenohumeral Internal Rotation Deficit and Proprioception', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'The Effect of End-range Maitland Mobilization on Glenohumeral Internal Rotation Deficit and Proprioception in Volleyball Players', 'orgStudyIdInfo': {'id': 'Maitland_GIRD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'End-range mobilization + proprioception training', 'description': 'End-range Maitland mobilization performed in end-range internal rotation of the shoulder accompanied with 8--week long proprioception training', 'interventionNames': ['Procedure: End-range Maitland mobilization + proprioception training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non end-range mobilization+ proprioception training', 'description': 'Non end-range Maitland mobilization performed in loose position of the shoulder accompanied with 8--week long proprioception training', 'interventionNames': ['Procedure: Non end-range Maitland mobilization + proprioception training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham manual therapy technique + proprioception training', 'description': 'Placebo performed in loose position of the shoulder accompanied with 8--week long proprioception training', 'interventionNames': ['Procedure: Sham manual therapy technique + proprioception training']}], 'interventions': [{'name': 'End-range Maitland mobilization + proprioception training', 'type': 'PROCEDURE', 'description': 'End-range Maitland mobilization performed in end position of internal rotation of the shoulder accompanied with 8--week long proprioception training', 'armGroupLabels': ['End-range mobilization + proprioception training']}, {'name': 'Non end-range Maitland mobilization + proprioception training', 'type': 'PROCEDURE', 'description': 'Non end-range Maitland mobilization performed in loose position of the shoulder accompanied with 8--week long proprioception training', 'armGroupLabels': ['Non end-range mobilization+ proprioception training']}, {'name': 'Sham manual therapy technique + proprioception training', 'type': 'PROCEDURE', 'description': 'Placebo performed in loose position of the shoulder accompanied with 8--week long proprioception training', 'armGroupLabels': ['Sham manual therapy technique + proprioception training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7815', 'city': 'Harkány', 'state': 'Please Select', 'country': 'Hungary', 'facility': 'Harkány Thermal Rehabilitation Centre', 'geoPoint': {'lat': 45.85002, 'lon': 18.23668}}], 'overallOfficials': [{'name': 'Miklós Pozsgai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harkány Thermal Rehabilitation Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}