Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-27 @ 1:03 PM
Study NCT ID:
NCT02389205
Status:
UNKNOWN
Last Update Posted:
2015-03-19
First Post:
2014-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Functional Activities and Balance Ability With Taping in Subjects of Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'standing balance ability (biodex balance system)', 'timeFrame': '3 months', 'description': 'biodex balance system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemophilia']}, 'referencesModule': {'references': [{'pmid': '22785085', 'type': 'RESULT', 'citation': 'Rodriguez-Merchan EC. Orthopaedic problems about the ankle in hemophilia. J Foot Ankle Surg. 2012 Nov-Dec;51(6):772-6. doi: 10.1053/j.jfas.2012.06.005. Epub 2012 Jul 10.'}]}, 'descriptionModule': {'briefSummary': "Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity (Range of Motion) decreasing and other musculoskeletal and related disorder. Patients will produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding, and joint damage. There is high rate of ankle joint bleeding in hemophilia. The ankle articular joint disease will affect lower limbs activities, and the functional activities will impaired.\n\nReview studies, in addition to physical therapy, Kinesio taping is a common intervention to improve other subjects' static balance, proprioception, functional ankle stability, correct poor posture.\n\nThe main intervention of this study is physical therapy and Kinesio taping, expect to improve the stability and muscular strength of lower extremities, and balance, correcting gait and lower extremity functional activities of subjects with hemophilia.", 'detailedDescription': 'Methods:\n\nThis study is a randomized controlled trial, the subjects were randomly divided into two groups, the control group received physical therapy once a week for a period of three months; experimental group received the same physical therapy in addition to treatment, but each will be accepted Kinesio taping. Experiments group carried out before and after the relevant tests, including: muscle strength, balance, lower extremity functional activities. The participants will be followed for the duration of physical therapy , an expected average of 3 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject of Hemophilia\n* 20-65 years old\n\nExclusion Criteria:\n\n* Any history of surgery'}, 'identificationModule': {'nctId': 'NCT02389205', 'briefTitle': 'The Effect of Functional Activities and Balance Ability With Taping in Subjects of Hemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Rehabilitation Department of Tri-Service General Hospital', 'orgStudyIdInfo': {'id': 'TSGH-105-165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'physical therapy'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'kinesio group', 'description': 'kinesio taping for ankle joint', 'interventionNames': ['Other: kinesio group']}], 'interventions': [{'name': 'kinesio group', 'type': 'OTHER', 'description': "kinesio group, The kinesio Taping® Method is a definitive rehabilitative taping technique that is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion as well as providing extended soft tissue manipulation to prolong the benefits of manual therapy administered within the clinical setting.\n\nThe effect of intervention may affected by the varying durations and frequencies of exercise, different state of arthropathy and joint range of motion limitations of ankle , etc.", 'armGroupLabels': ['kinesio group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chan Yuan-Chi', 'role': 'CONTACT', 'email': 'mmagggie@hotmail.com', 'phone': '+886287923311', 'phoneExt': '17068'}, {'name': 'Le Tsung-Ying', 'role': 'CONTACT', 'email': 'doc31141@gmail.com', 'phone': '+886287923311', 'phoneExt': '88098'}], 'overallOfficials': [{'name': 'Chen Liang-Cheng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of Rehabilitation department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physical therapist', 'investigatorFullName': 'Chan Yuan-Chi', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}