Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-31 @ 10:46 AM
Study NCT ID:
NCT05230056
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2022-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Therapy in Shoulder Rehabilitation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shoulder pain', 'timeFrame': 'From baseline up to two weeks', 'description': 'Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)'}, {'measure': 'shoulder strength', 'timeFrame': 'From baseline up to two weeks', 'description': 'Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '37420268', 'type': 'DERIVED', 'citation': 'Rizzato A, Pizzichemi M, Gobbi E, Gerardi A, Fortin C, Copcia A, Paoli A, Marcolin G. Effectiveness and therapeutic compliance of digital therapy in shoulder rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2023 Jul 8;20(1):87. doi: 10.1186/s12984-023-01188-7.'}]}, 'descriptionModule': {'briefSummary': "Digital therapy may provides real time visual feedbacks. Instrumented devices objectively quantify the patient's performance during rehabilitation and thus could be helpful for the personalization of the exercises.\n\nThe interactive ball of this trial allows measuring both movement and pressure applied on it. Therefore, the objectives of this study are: (i) to evaluate whether the use of a novel digital therapy gaming system was therapeutically relevant during shoulder rehabilitation; (ii) to understand whether the device was effective in improving patients' engagement in comparison to a control non-gaming rehabilitation program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* impingement syndrome, capsulitis, tendon injuries, degenerative joint or tendon pathologies\n* pain between 2/10 and 8/10 on a visual analogue scale\n\nExclusion Criteria:\n\n* post-surgical patients\n* inability to perform active exercises\n* peripheral neurological deficits\n* cervical-brachialgia\n* algodystrophy'}, 'identificationModule': {'nctId': 'NCT05230056', 'briefTitle': 'Digital Therapy in Shoulder Rehabilitation.', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.', 'orgStudyIdInfo': {'id': 'PLYDT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PG', 'interventionNames': ['Behavioral: PG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CTRL', 'interventionNames': ['Behavioral: CTRL']}], 'interventions': [{'name': 'PG', 'type': 'BEHAVIORAL', 'description': 'Shoulder Digital therapy', 'armGroupLabels': ['PG']}, {'name': 'CTRL', 'type': 'BEHAVIORAL', 'description': 'Shoulder non-digital therapy', 'armGroupLabels': ['CTRL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35131', 'city': 'Padua', 'country': 'Italy', 'facility': 'Nutrition and Exercise Lab, DSB, University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}