Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT04590456
Status:
UNKNOWN
Last Update Posted:
2020-12-22
First Post:
2020-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulsed Electromagentic Field in Haemophilia
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-19', 'studyFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2020-10-11', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'swelling', 'timeFrame': 'basline and after 3 months of intervention.', 'description': 'The swelling degree was detected by tape'}], 'secondaryOutcomes': [{'measure': 'range of motion', 'timeFrame': 'basline and after 3 months of intervention.', 'description': 'Active knee range of flexion and extension were measured by electronic goniometer.'}, {'measure': 'muscle strength', 'timeFrame': 'basline and after 3 months of intervention.', 'description': 'The peak concentric knee extensor (KE) and the peak concentric knee flexor (KF) was measured at 60/s angular speed by an isokinetic dynamometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '24472015', 'type': 'BACKGROUND', 'citation': 'Gringeri A, Ewenstein B, Reininger A. The burden of bleeding in haemophilia: is one bleed too many? Haemophilia. 2014 Jul;20(4):459-63. doi: 10.1111/hae.12375. Epub 2014 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of pulsed electero- magnetic field on swelling, range of motion and muscle strength of hemarthrotic knee joints of haemophilic subjects.', 'detailedDescription': "Haemophilia is an X-linked hereditary sex recessive disorder that impairs the body's ability to make blood clots. It includes two types: A (FVIII deficit factor) and B (IX deficit factor), depending on FVIII/FIX percentage in blood. The severity of haemophilia is classified into (severe: \\<1%, moderate: 1-5%, and mild: \\>5%). The prevalence of haemophilia A is 1: 5000 live births and haemophilia B is 1: 30000 live births.\n\nThis disease is characterized by hemarthrosis which is a hemorrhage in the locomotor system, mainly muscles and joints. Joint bleeding mainly occurs in knees, ankles and elbows. Haemorrhage in the muscle or joints accounts for 80% to 90% of all bleeding episodes in people with haemophilia. The most commonly affected joints in non-prophylaxis patients are the knees (45%) which is thought to be due to the large size of the synovial membrane and large rotational forces present. It is followed by the elbows (30%), ankles (15%), shoulders (3%), and wrists (2%). Bleeds are best detected by the patients themselves as bruising and swelling or described as a feeling of warmth or tingling within the joint preceding the clinical signs.\n\nPulsed electromagnetic field (PEMF) has been reported to be effective in reducing pain, healing of ulcers and promote bone healing, and treating osteoarthritis and inflammatory diseases of the musculoskeletal system. Also, it was reported that PEMF exposure significantly increases the anti-inflammatory effect, suggesting its potential therapeutic use in the treatment of inflammatory bone and joint disorders."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type A hemophilia (moderate)\n* free from any musculoskeletal deformities.\n\nExclusion Criteria:\n\n* patients who performed surgical procedures 6 weeks before conducting the study'}, 'identificationModule': {'nctId': 'NCT04590456', 'briefTitle': 'Pulsed Electromagentic Field in Haemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Delta University for Science and Technology'}, 'officialTitle': 'Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence', 'orgStudyIdInfo': {'id': 'PEMF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo group', 'interventionNames': ['Other: PEMF']}, {'type': 'EXPERIMENTAL', 'label': 'PEMF group', 'interventionNames': ['Other: PEMF']}], 'interventions': [{'name': 'PEMF', 'type': 'OTHER', 'description': 'group A received 60 minutes of traditional program physical therapy which consisted of passive range of motion, stretching,proprioception, isotonic and isometric and 20 minutes of placebo treatment using PEMF, while group B received the same traditional physical therapy program given to the control group in addition of 20 minutes of PEMF therapy', 'armGroupLabels': ['PEMF group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4030', 'city': 'Gamasa', 'state': 'Dakahelia', 'country': 'Egypt', 'facility': 'Delta University for Science and Technology', 'geoPoint': {'lat': 31.44112, 'lon': 31.53675}}], 'overallOfficials': [{'name': 'Hala I. Kassem, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of physical therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delta University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy', 'investigatorFullName': 'walaa eldesoukey heneidy', 'investigatorAffiliation': 'Delta University for Science and Technology'}}}}