Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06977620
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of CKC and WS Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-11', 'size': 796741, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-10T08:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single-blind (participant)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be four-armed, single-blind (participant), parallel-group, randomized control trial. Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups by using simple randomization technique 1:1 ratio to four equal groups according to sample size calculation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-05-03', 'studyFirstSubmitQcDate': '2025-05-10', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinesis Balance™ fall prevention app', 'timeFrame': 'Eight weeks', 'description': 'Patients will be instructed to hold the phone firmly against their sternum and stand with their eyes open, in a semi-tandem stance, for 30 s. The app contains audio and visual instructions on how to prepare for and complete the test as well as an audio cue to indicate test start and stop.'}], 'secondaryOutcomes': [{'measure': 'Time Up and Go Test (TUG)', 'timeFrame': 'Eight weeks', 'description': 'Patients will be asked to stand up from a chair with armrests, walk three meters, turn, walk back, and sit down. The time taken to complete this task will be measured in seconds using a stopwatch'}, {'measure': 'Functional Reach Test (FRT)', 'timeFrame': 'Eight weeks', 'description': 'The patient will enter a standing position on a line marked on the floor. An inch tape will be attached to a wall at approximately shoulder height of the subject. The therapist will stand 5-10 feet away from the patient and instruct them to stand close to the wall without touching it, while facing the inch tape, with the shoulder flexed at 90° and the hand in a fist. The therapist will record the starting position at the knuckle of the third metacarpal head on the ruler. The patient will then be instructed to reach as far forward as possible along the length of the tape without moving their feet. The therapist will once again record the location of the knuckle of the third metacarpal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postural stability', 'closed kinetic chain exercises', 'weight shifting exercises'], 'conditions': ['Postmastectomy Lymphedema']}, 'descriptionModule': {'briefSummary': "Post-mastectomy lymphedema is one of the most common chronic complications that significantly impacts patients' quality of life following breast cancer surgery. postural stability is maintained through the intricate integration of muscular forces, sensory input from mechanoreceptors, and biomechanical feedback. closed kinetic chain (CKC) exercises play a crucial role in enhancing musculoskeletal stability by countering gravitational forces during both rest and movement. weight shifting and balance are fundamental components of functional movement. Proprioceptive training, which focuses on improving body awareness and balance, is essential for developing trunk control", 'detailedDescription': 'Sixty patients who have unilateral post mastectomy lymphedema will participate in this study. Their ages will range from 40 to 60 years. The patients will be subdivided randomly into four equal groups.\n\n1.1.a- Group A (n= 15) (CKC group): This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.\n\n1.1.b- Group B (n= 15) (WS group): This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.\n\n1.1.c- Group C (n= 15) (Combined group): This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks.\n\n1.1.d- Group D (n= 15) (control group): This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Women who had a history of BCRS with upper limb lymphedema', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen who had a history of BCRS with upper limb lymphedema. • Age range of 40-60 years.\n\n• The body mass index (BMI) is less than 30 Kg/m2.\n\n• Consciousness and ability to communicate orally or in writing.\n\n• Treatment by unilateral mastectomy with lymph node dissection.\n\n• No obvious abnormal spine morphology or postural abnormalities visible to the naked eye.\n\n• All participants had moderate lymphedema according to the lymphedema severity assessment.\n\nExclusion Criteria:\n\nPatients with metastases. • Differences between lower limb length.\n\n• Having acute or chronic vestibular, neurological, and orthopedic diseases.\n\n• Surgery related to spine causing limitation of motion.\n\n• Women with psychiatric disorders, reconstructive surgery.\n\n• Bilateral mastectomy. Diagnosis with a neurological, skeletal, or rheumatic disorder or other disease that seriously affects body posture.\n\n• History of bodily injury such as a spinal, shoulder, or neck injury, resulting in permanent alteration of the normal body posture prior to the unilateral mastectomy.\n\n• Failure to complete follow-up for any reason over the course of the study.\n\n• Peripheral polyneuropathy, cognitive dysfunction.\n\n• Patients taking medication that affects body balance.\n\n• Severe arthritis or orthopedic conditions in their lower extremity\n\n• Poor conditioning, acute pain in any reason,\n\n• Neurological disorders including visual problems.'}, 'identificationModule': {'nctId': 'NCT06977620', 'briefTitle': 'Effect of CKC and WS Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Closed Kinetic Chain and Weight Shifting Exercises on Postural Stability in Unilateral Post Mastectomy Lymphedema', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005746'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (CKC group)', 'description': 'This group will include 15 patients who will receive closed kinetic chain exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises). The total exercise time will be 30 minutes, three times per week for eight weeks.', 'interventionNames': ['Other: Closed kinetic chain exercises', 'Other: Complete Decongestive Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (WS group):', 'description': 'This group will include 15 patients who will receive weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 30 minutes, three times per week for eight weeks.', 'interventionNames': ['Other: Weight shifting exercises', 'Other: Complete Decongestive Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C (Combined group)', 'description': 'This group will include 15 patients who will receive closed kinetic chain and Weight shifting exercises, in addition to complex decongestive therapy (CDT) for the treatment of lymphedema. The total exercise time will be 60 minutes; 30 minutes of CKC and 30 minutes of WS exercise three times per week for eight weeks', 'interventionNames': ['Other: Closed kinetic chain exercises', 'Other: Weight shifting exercises', 'Other: Complete Decongestive Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group D (control group)', 'description': 'This group will include 15 patients who will receive complex decongestive therapy (CDT) for the treatment of lymphedema. CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).', 'interventionNames': ['Other: Complete Decongestive Therapy']}], 'interventions': [{'name': 'Closed kinetic chain exercises', 'type': 'OTHER', 'otherNames': ['CKC'], 'description': 'Closed kinetic chain (CKC) exercises emphasize weight-bearing movements where the distal segment of the extremity is fixed, and motion occurs as the proximal segment moves over the stabilized distal segment.', 'armGroupLabels': ['Group A (CKC group)', 'Group C (Combined group)']}, {'name': 'Weight shifting exercises', 'type': 'OTHER', 'otherNames': ['WS'], 'description': "Weight-shifting is a crucial aspect of dynamic postural control, which refers to the ability to maintain one's bodyweight within the base of support. Lateral weight-shifting, in particular, is essential for maintaining posture under dynamic conditions and is commonly performed in various activities of daily living", 'armGroupLabels': ['Group B (WS group):', 'Group C (Combined group)']}, {'name': 'Complete Decongestive Therapy', 'type': 'OTHER', 'otherNames': ['CDT'], 'description': 'CDT includes (skin care, manual lymphatic drainage, compression bandages, compression garments and exercises).', 'armGroupLabels': ['Group A (CKC group)', 'Group B (WS group):', 'Group C (Combined group)', 'Group D (control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Aya Kamal, PHD', 'role': 'CONTACT', 'email': 'ayakamaline164@gmail.com', 'phone': '01030362230'}, {'name': 'Aya Kamal, PHD', 'role': 'CONTACT', 'email': 'ayakamaline164@cu.eg.edu', 'phone': '01030362230'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Aya Kamal, PHD', 'role': 'CONTACT', 'email': 'ayakamaline164@gmail.com', 'phone': '01030362230'}, {'name': 'Aya Kamal, PHD', 'role': 'CONTACT', 'email': 'ayakamaline164@cu.edu.eg', 'phone': '01030362230'}], 'overallOfficials': [{'name': 'Aya Kamal, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Teaching Assistant of Physical Therapy for Surgery Cairo University Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'January, 2027', 'ipdSharing': 'YES', 'description': 'Publication at international journal', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Aya Kamal Mousa Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}