Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 3:03 PM
Study NCT ID:
NCT07014566
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Limb Volume', 'timeFrame': 'At baseline, at week 4 (end of treatment), and at week 12 (follow-up)', 'description': 'Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': 'At baseline, at week 4 (end of treatment), and at week 12 (follow-up)', 'description': 'Quality of life was assessed using the Turkish version of the Lymphedema Functioning, Disability and Health Questionnaire (Lymph-ICF), which is specific to lymphedema. The scale consists of 29 items across five domains: physical function, mental function, household activities, mobility activities, and social life. Each item was scored on a 0-100 mm visual analog scale (VAS), where higher scores indicate greater impairment and reduced quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lower extremity lymphedema', 'Digital physiotherapy', 'Combined decongestive therapy'], 'conditions': ['Lower Extremity Lymphedema']}, 'referencesModule': {'references': [{'pmid': '32402630', 'type': 'BACKGROUND', 'citation': 'Wu X, Liu Y, Zhu D, Wang F, Ji J, Yan H. Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer. Asian J Surg. 2021 Jan;44(1):111-115. doi: 10.1016/j.asjsur.2020.03.022. Epub 2020 May 10.'}]}, 'descriptionModule': {'briefSummary': 'This study investigated the short- and long-term effects of digital physiotherapy in patients with unilateral and bilateral lower extremity lymphedema. Limb volume and quality of life were assessed at baseline, post-treatment, and 12-week follow-up.', 'detailedDescription': 'This study evaluated the feasibility and effectiveness of a digital physiotherapy program based on combined decongestive therapy in patients with lower extremity lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital physiotherapy program with remote supervision. Compression stockings were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymphoedema functioning, disability and health questionnaire questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with unilateral lower extremity lymphedema (either primary or secondary)\n* Patients aged 18 years or older\n\nExclusion Criteria:\n\n* Presence of metastatic disease\n* History of coronary heart disease, pulmonary disease, or acute infection of any cause\n* Presence of peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT07014566', 'briefTitle': 'Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema', 'orgStudyIdInfo': {'id': 'Lenfödemalt2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Combined Decongestive Therapy Group', 'description': 'Patients received digital combined decongestive therapy, including self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care education, with remote supervision over 4 weeks, followed by a maintenance phase with compression stockings.', 'interventionNames': ['Other: Digital Combined Decongestive Therapy']}], 'interventions': [{'name': 'Digital Combined Decongestive Therapy', 'type': 'OTHER', 'description': 'The intervention consisted of a digitally delivered combined decongestive therapy (CDT) program for patients with unilateral or bilateral lower extremity lymphedema. Patients attended a single face-to-face session where a physiotherapist provided training on skin care, self-bandaging, self-manual lymphatic drainage, and therapeutic exercises (breathing, gluteal sets, knee sets, and toe movements). Caregivers recorded the demonstrations for home use. Following this session, a 4-week remote physiotherapy program was implemented using telecommunication technologies. Patients continued self-management with guidance via digital platforms. Compression stockings replaced self-bandaging during the 12-week follow-up phase.', 'armGroupLabels': ['Digital Combined Decongestive Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakıf University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Selva Otsay', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}