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NCT05549843 | Completed | Hemophilia


Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle
Sponsor:

Research in Hemophilia and Physiotherapy

Brief Summary:

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity. Design. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy. Patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in seven centers, from different regions of Spain. Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 weeks. The treatment program includes 10 exercises that must be administered bilaterally. Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint pain); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment. Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health and pressure pain threshold.

Condition or disease

Hemophilia

Intervention/treatment

Manual therapy

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 24 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : Safety and Efficacy of Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle. A Pilot Study
Actual Study Start Date : October 14, 2022
Estimated Primary Completion Date : November 18, 2022
Estimated Study Completion Date : February 26, 2023
Arm Intervention/treatment

Experimental: Hemophilia group

Intervention protocol: Preparatory work: active mobilizations with the patient supine. Global passive mobilization of the forefoot and midfoot. Calcaneocuboid mobilization, functional and structural work of said joint. Astragaloscaphoid mobilization, functional and structural work of said joint. Talar manipulation dorsally. Manipulation-tibial displacement: Tibiotarsal decompression: 2 very gentle high-speed and short-course tibial-tarsal manipulations. Plantar fascia induction for foot captors of the plantar fascia. Tibiotarsal sustained traction technique (unwinding) Sural triceps induction technique:

Other: Manual therapy

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Patients diagnosed with hemophilia A and B
  • With severe (<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia
  • Over 18 years
  • With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score
  • In prophylactic treatment with FVIII / FIX concentrates for coagulation
Exclusion Criteria
  • Patients with inhibitors (antibodies against FVIII or FIX)
  • Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests
  • Failure to sign the informed consent document

Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle

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Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle

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Locations


Not yet recruiting

Spain, Asturias

University of Oviedo

Oviedo, Asturias, Spain, 33006

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