Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 6:52 AM
Study NCT ID:
NCT02958332
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2016-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Range motion', 'timeFrame': 'Pre intervention and one week after having finished the program'}, {'measure': 'Change in strength', 'timeFrame': 'Pre intervention and one week after having finished the program'}, {'measure': 'Change in Oxford Shoulder Scale', 'timeFrame': 'Pre intervention and one week after having finished the program'}, {'measure': 'Change in Shoulder Pain and Disability Index', 'timeFrame': 'Pre intervention and one week after having finished the program'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life (FUNCTIONAL ASSESMENT OF CANCER THERAPY QUESTIONNAIRE FOR BREAST CANCER (FACT-B+4)', 'timeFrame': 'Pre intervention and one week after having finished the program'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['video games'], 'conditions': ['Lymphedema', 'Breastcancer']}, 'descriptionModule': {'briefSummary': 'Aims: To demonstrate the effect of a program based on video games as a means to improve abilities and basic skills affected by lymphedema, and its impact on quality of life.\n\nDesign: longitudinal, pre-experimental, with pre / post-test and evaluation, assessor blinded study.\n\nMethod: Data on shoulder pain and disability, health-related quality of life, strength and articulate activated by the OSS (Oxford Shoulder Score), SPADI (Shoulder Pain and Disability Index), FACT-B + 4 (Functional Assesment of Cancer Therapy Questionnaire for Breast Cancer), respectively goniometry and dynamometry amplitude scales will be collected.\n\nThe intervention will be performed with the Wii ™ console and the Wii Balance BoardTM, during 5 individual weekly sessions of 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 18 years\n* Have a diagnosis of lymphedema, secondary to breast cancer\n\nExclusion Criteria:\n\n* Stage 0 or subclinical lymphedema\n* Present other shoulder pathology apart from lymphedema'}, 'identificationModule': {'nctId': 'NCT02958332', 'briefTitle': 'Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Burgos'}, 'officialTitle': 'Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer', 'orgStudyIdInfo': {'id': 'CB-MSV-19-09-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'video game program', 'description': 'Participants will play video games during 30 min , all along 5 sessions.', 'interventionNames': ['Other: video game program']}], 'interventions': [{'name': 'video game program', 'type': 'OTHER', 'description': 'Participants will use the Wii console and the Wii balance board, to play different video games which imply shoulder movements. They will receive 5 individual sessions of 30 minutes.', 'armGroupLabels': ['video game program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09001', 'city': 'Burgos', 'country': 'Spain', 'facility': 'Universidad de Burgos. Facultad de Ciencias de la Salud.', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}], 'overallOfficials': [{'name': 'Montserrat Santamaría-Vázquez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Burgos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Burgos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}