Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-30 @ 2:26 PM
Study NCT ID:
NCT05934695
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2023-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder joint mobility', 'timeFrame': 'baseline', 'description': 'shoulder flexion, abduction, external rotation and extension range of motion measured using a digital inclinometer.'}, {'measure': 'Muscle activation patterns (Amplitude)', 'timeFrame': 'baseline', 'description': 'Surface EMG recording of muscle activation patterns (amplitude) of the biceps brachii, anterior/middle/posterior deltoid, pectoralis major and latissimus dorsi during shoulder elevation. Amplitude will be reported in units of microvolts (µV)'}, {'measure': 'Muscle activation patterns (Timing)', 'timeFrame': 'baseline', 'description': 'Surface EMG recording of muscle activation patterns (timing) of the biceps brachii, anterior/middle/posterior deltoid, pectoralis major and latissimus dorsi during shoulder elevation. Timing will be reported in units of milliseconds (ms).'}], 'secondaryOutcomes': [{'measure': 'Shoulder flexors strength', 'timeFrame': 'baseline', 'description': 'Maximal shoulder flexor abductor strength measured as force production (N) using a handheld dynamometer. The average of 3 trials for each muscle group will be calculated.'}, {'measure': 'Shoulder abductor strength', 'timeFrame': 'baseline', 'description': 'Maximal shoulder abductor strength measured as force production (N) using a handheld dynamometer. The average of 3 trials for each muscle group will be calculated.'}, {'measure': 'Self-reported upper extremity function', 'timeFrame': 'baseline', 'description': 'The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, developed by the Institute for Work and Health, is used to measure patient-reported functional outcomes. The DASH questionnaire consists of 30 questions regarding limitations to complete physical activities due to upper extremity pain/impairment. Participants will be asked to respond to each question based on their experiences over the preceding week according to a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to do). Responses will be scored out of 5 and averaged to produce a score out of 100 with higher scores representing greater disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'Breast cancer-related lymphedema (BCRL) is a common complication affecting the upper extremity following breast cancer treatment. This study aims to investigate the relationship between lymphedema severity and shoulder joint function and muscle activation patterns in breast cancer survivors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study aims to recruit women with different severity levels of breast cancer-related lymphedema, an upper limb condition that can result from breast cancer treatment causing swelling and other impairments. By assessing women at different points along the continuum of lymphedema severity, the impact of severity on shoulder function and related outcomes can be examined.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Adults (18 years or older)\n* Diagnosis of breast cancer-related lymphedema for a minimum of 3 months\n* No current evidence of active cancer\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pre-existing musculoskeletal conditions affecting the upper extremities (e.g. adhesive capsulitis, rotator cuff tear)\n* Previous upper extremity surgery\n* Physical inability to perform the required physical movements and assessments'}, 'identificationModule': {'nctId': 'NCT05934695', 'briefTitle': 'Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'The Impact of Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '010/28202306'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild lymphedema (stage 1)', 'description': 'International Society of Lymphology lymphedema severity stage 1, characterized by swelling with pitting, normal skin and tissue turgor. Participants assigned to this group will have mild swelling and tightness of the arm.', 'interventionNames': ['Other: Lymphedema severity stratification']}, {'label': 'Moderate lymphedema (stage 2)', 'description': 'International Society of Lymphology lymphedema severity stage 2, characterized by swelling with pitting as well as skin and tissue changes such as dermal thickening. Participants assigned to this group will have moderate swelling and tightness of the arm as well as skin changes without distortional warty-overgrowth or elephantiasis folds.', 'interventionNames': ['Other: Lymphedema severity stratification']}, {'label': 'Severe lymphedema (stage 3)', 'description': 'International Society of Lymphology lymphedema severity stage 3, characterized by swelling with non-pitting, and warty-overgrowth or elephantiasis folds of skin. Participants assigned to this group will have severe swelling and tightness of the arm with warty overgrowth of skin.', 'interventionNames': ['Other: Lymphedema severity stratification']}], 'interventions': [{'name': 'Lymphedema severity stratification', 'type': 'OTHER', 'description': 'Participants will be stratified into one of three lymphedema severity groups based on the International Society of Lymphology lymphedema severity staging:\n\nMild (stage 1): swelling with pitting; normal skin and tissue turgor Moderate (stage 2): swelling with pitting; dermal thickening; skin changes without distortional warty-overgrowth Severe (stage 3): swelling with non-pitting; warty overgrowth or elephantiasis folds', 'armGroupLabels': ['Mild lymphedema (stage 1)', 'Moderate lymphedema (stage 2)', 'Severe lymphedema (stage 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3221405', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}], 'overallOfficials': [{'name': 'Amal Fawzy, Ph.d', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Physical Therapy, Ahram Canadian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Therapy and Director of Electromyography Lab', 'investigatorFullName': 'Mohamed Magdy ElMeligie', 'investigatorAffiliation': 'Ahram Canadian University'}}}}