Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-05 @ 12:36 PM
Study NCT ID:
NCT02825667
Status:
COMPLETED
Last Update Posted:
2017-09-28
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-26', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-07-04', 'lastUpdatePostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline bleeding frequency after treatment and at 5 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after five months follow-up visit', 'description': 'Evaluation of the frequency of muscle and joint bleeds through registration. The frequency of bleeding of the ankle joint is measured with a registry given to patients at the beginning of the study.'}, {'measure': 'Change from baseline joint pain of ankle after treatment and at 5 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after five months follow-up visit', 'description': 'Change from joint pain of ankle during treatment and follow-up period at 5 months. The perception of ankle pain will be measured using visual analog scale (scale 0-10).'}, {'measure': 'Change from baseline joint function after treatment and at 5 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after five months follow-up visit', 'description': 'Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).'}, {'measure': 'Change from baseline range of motion after treatment and at 5 months', 'timeFrame': 'Screening visit, within the first seven days after treatment and after five months follow-up visit', 'description': 'Change from range of movement of ankle and knee during treatment and follow-up period at 5 months. The range of motion of the ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol.\n\nMeasurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Screening visit', 'description': 'Age of patients'}, {'measure': 'Weight', 'timeFrame': 'Screening visit', 'description': 'Weight of patients included in the study'}, {'measure': 'Height', 'timeFrame': 'Screening visit', 'description': 'Height of patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Haemophilia', 'Ankle', 'Arthropathy', 'Pain', 'Range of motion', 'Myofascial techniques'], 'conditions': ['Haemophilia']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the observed differences on the dependent variables: range of motion, pain and physical condition.\n\nAt the same time, the study will determine whether there are adverse effects or bleeding complications as a result of applied physiotherapy treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with hemophilia A and B\n* Adults patients\n* Patients with hemophilic arthropathy of ankle diagnosed\n* Patients in prophylactic treatment regimen or on demand treatment with concentrates of FVIII/FIX.\n\nExclusion Criteria:\n\n* Patients without ambulation\n* Patients diagnosed with other congenital coagulopathy (eg, Von Willebrand disease)\n* Patients who have developed antibodies to FVIII / FIX (inhibitors)\n* Patients with neurological or cognitive impairments that prevent understanding of questionnaires and test physical\n* Patients that have not signed the informed consent document.'}, 'identificationModule': {'nctId': 'NCT02825667', 'briefTitle': 'Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle', 'organization': {'class': 'OTHER', 'fullName': 'Real Fundación Victoria Eugenia'}, 'officialTitle': 'Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle', 'orgStudyIdInfo': {'id': 'AnHe-Fascial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients included in this group will receive treatment over a period of three weeks, receiving 3 physiotherapy sessions lasting approximately 30 minutes each.\n\nThe treatment program includes 8 maneuvers that must be administered bilaterally: maneuver longitudinal sliding on the fascial surface plant, maneuver induction of the plantar fascia, maneuver longitudinal surface sliding on the anterolateral compartment of the leg, induction maneuver ankle anterior compartment, maneuver pressure and sliding on the posterior region of the leg, technical release of the popliteal fascia, maneuver induction sural triceps, and lower extremity telescopic technique.', 'interventionNames': ['Other: Physiotherapy sessions']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients included in this group will not receive any physiotherapy treatment. However, will be evaluated under the same conditions that patients in the experimental group (pretreatment evaluation, post-treatment and follow-up).'}], 'interventions': [{'name': 'Physiotherapy sessions', 'type': 'OTHER', 'description': 'Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Real Fundación Victoria Eugenia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Real Fundación Victoria Eugenia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}