Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-28 @ 10:46 PM
Study NCT ID:
NCT02929433
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cycloergometer and Rotator Cuff Tear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Numeric Scale (VNS)', 'timeFrame': 'Change from Baseline VNS at 6 months after the out-patient rehabilitation', 'description': 'The scale evaluated shoulder pain during activity'}], 'secondaryOutcomes': [{'measure': 'Constant-Murley scale', 'timeFrame': 'Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation', 'description': 'The scale evaluated shoulder functionality'}, {'measure': 'Health Assessment Questionnaire (HAQ)', 'timeFrame': 'Change from Baseline HAQ at 6 months after the out-patient rehabilitation', 'description': 'The Questionnaire evaluated Disability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['disability', 'pain', 'Rotator Cuff Tear', 'rehabilitation', 'range of motion (ROM)'], 'conditions': ['Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. The cycloergometer has been already employed in many fields of medicine.\n\nHowever, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in Rotator Cuff Tear patients.', 'detailedDescription': 'To evaluate the effects of cycloergometer on pain during activities (primary outcome) and shoulder functionality, the investigators performed a prospective randomized controlled study (pilot study) in patients with a symptomatic full-thickness RCT.\n\nSince cycloergometer works through a continuous active and passive joint mobilization, the investigators expect it can reduce pain and improve shoulder functionality becoming a useful tool for physicians in the management of RCT patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* positive imaging diagnosis of full-thickness RCT\n* surgery not considered as the first treatment of choice\n* willingness to sign the informed consent form.\n\nExclusion Criteria:\n\n* inflammatory rheumatic diseases\n* history of fracture or operations around the shoulder region\n* neurological diseases\n* infections or tumours\n* diabetes\n* coagulation diseases\n* intra-articular injections of the involved shoulder within the last 12 months.'}, 'identificationModule': {'nctId': 'NCT02929433', 'briefTitle': 'Cycloergometer and Rotator Cuff Tear', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Salvatore Maugeri'}, 'officialTitle': 'Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer', 'orgStudyIdInfo': {'id': 'cts 2012-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cycloergometer group', 'description': 'Training at home with the cycloergometer per 20 minutes twice a day. The protocol suggested a continous use of the cycloergometer for a period of 6 months after 2 weeks of rehabilitation as outpatient.', 'interventionNames': ['Other: Cycloergometer']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care after a period (2 weeks) of rehabilitation as outpatient.'}], 'interventions': [{'name': 'Cycloergometer', 'type': 'OTHER', 'description': 'Daily training of the RCT patients was provided by the use of a cycloergometer at home. Educational support once a month was guaranteed by a nurse of the telemedicine service', 'armGroupLabels': ['Cycloergometer group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bernardo Gialanella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Salvatore Maugeri'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Scientific manuscript'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Salvatore Maugeri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Bernardo Gialanella', 'investigatorAffiliation': 'Fondazione Salvatore Maugeri'}}}}