Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 2:48 AM
Study NCT ID:
NCT05726656
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy Lymphedema Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072656', 'term': 'Breast Cancer Lymphedema'}], 'ancestors': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shoulder range of motion', 'timeFrame': '4 weeks', 'description': 'flexion, extension, abduction, adduction , internal rotation and external rotation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postmastectomy Lymphedema']}, 'descriptionModule': {'briefSummary': 'PURPOSE: To determine the effect of wii-console based exercise on shoulder ROM of both sides for post-mastectomy patients, and highlighting the effect of dominancy.', 'detailedDescription': 'Breast cancer has been the focused of many studies because it significantly affects both in developed and developing countries worldwide (Cameirão et al, 2008).\n\nLymphedema affects the range of motion of shoulder causing disability and affection of function.\n\nWii-console systems can be used as training tools to promote intensive training directed towards specific deficits and guide the patients in task-oriented activities. Moreover, it allows a real-time high-resolution monitoring, where is possible to have a quantitative assessment of relevant properties of the impairment, performance and recovery. On the other hand, virtual reality environment demand focus and attention of the patient, motivate the patient to perform the exercises, and provide a sense of achievement to the user (Torre et al, 2015).\n\nHYPOTHESES:\n\nThe wii-console based exercise will have no effect on shoulder ROM for post-mastectomy patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients will be females.\n* Patients undergone mastectomy with lymph nodes dissection.\n* all developed lymphedema after the surgery.\n\nExclusion Criteria:\n\n* Vision problems.\n* Medically instable patients.\n* Balance disorders.\n* Other musculoskeletal condition of shoulders.'}, 'identificationModule': {'nctId': 'NCT05726656', 'briefTitle': 'Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy Lymphedema Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wii console based exercise group', 'description': 'the patient will recieve wii console based exercise in addition to traditional physical therapy session', 'interventionNames': ['Other: traditional physical therapy session', 'Other: wii console based exercise']}, {'type': 'OTHER', 'label': 'control group', 'description': 'the patient will recieve only the traditional physical therapy session', 'interventionNames': ['Other: traditional physical therapy session']}], 'interventions': [{'name': 'traditional physical therapy session', 'type': 'OTHER', 'description': 'manual lymph drainage-pneumatic compression and skin care', 'armGroupLabels': ['control group', 'wii console based exercise group']}, {'name': 'wii console based exercise', 'type': 'OTHER', 'description': 'execise session using the wii console video games', 'armGroupLabels': ['wii console based exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Doaa A Atef, PHD', 'role': 'CONTACT', 'email': 'doozy.masr@gmail.com', 'phone': '01060267094', 'phoneExt': '002'}, {'name': 'Ayah M Mohamed, PHD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amany R Mohamed, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Doaa A Atef, PHD', 'role': 'CONTACT', 'email': 'doozy.masr@gmail.com', 'phone': '01060267094', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Doaa A Atef, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for surgery', 'investigatorFullName': 'doaa atef', 'investigatorAffiliation': 'Cairo University'}}}}