protocolSection identificationModule nctId: NCT06261593, orgStudyIdInfo id: Ankle-Blood, briefTitle: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2024-07-03, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Investigación en Hemofilia y Fisioterapia, class: NETWORK, descriptionModule briefSummary: Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, stability, joint pain, joint status and the perception of quality of life in patients with hemophilic ankle arthropathy.Study design. Randomized, multicenter, single-blind clinical study. Method. 32 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 4 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and stability (The Single Leg Stance Test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, stabilit, and the perception of quality of life in patients with hemophilic ankle arthropathy., conditionsModule conditions: Hemophilia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Blood flow restriction, outcomesModule primaryOutcomes measure: Change from baseline hemarthrosis after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline pressure pain threshold after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline muscle strength after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline electrical activity of the muscles after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline joint status after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline range of motion after treatment and at four weeks, secondaryOutcomes measure: Change from baseline balance after treatment and at four weeks, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Oviedo, status: RECRUITING, city: Oviedo, state: Asturias, zip: 33006, country: Spain, contacts name: Rubén Cuesta-Barriuso, PhD, role: CONTACT, geoPoint lat: 43.36029, lon: -5.84476, hasResults: False