Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

Study Overview
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Brief Summary
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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. At the same time, the study will determine whether there are adverse effects or bleeding complications as a result of applied physiotherapy treatment.

Official Title
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Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle

Conditions
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Haemophilia

Intervention / Treatment
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* Other: Physiotherapy sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with hemophilia A and B Adults patients Patients with hemophilic arthropathy of ankle diagnosed Patients in prophylactic treatment regimen or on demand treatment with concentrates of FVIII/FIX. Exclusion Criteria: Patients without ambulation Patients diagnosed with other congenital coagulopathy (eg, Von Willebrand disease) Patients who have developed antibodies to FVIII / FIX (inhibitors) Patients with neurological or cognitive impairments that prevent understanding of questionnaires and test physical Patients that have not signed the informed consent document.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patients included in this group will receive treatment over a period of three weeks, receiving 3 physiotherapy sessions lasting approximately 30 minutes each. The 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. | Other: Physiotherapy sessions<br>* Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy<br>|
| No Intervention: Control group<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline bleeding frequency after treatment and at 5 months | 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. | Screening visit, within the first seven days after treatment and after five months follow-up visit | 
| Change from baseline joint pain of ankle after treatment and at 5 months | 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). | Screening visit, within the first seven days after treatment and after five months follow-up visit | 
| Change from baseline joint function after treatment and at 5 months | Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20). | Screening visit, within the first seven days after treatment and after five months follow-up visit | 
| Change from baseline range of motion after treatment and at 5 months | 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. Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia | Screening visit, within the first seven days after treatment and after five months follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age of patients | Screening visit | 
| Weight | Weight of patients included in the study | Screening visit | 
| Height | Height of patients | Screening visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilia, Ankle, Arthropathy, Pain, Range of motion, Myofascial techniques