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Completed

NCT Number: NCT02825667

Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

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.

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Key information

Conditions

Haemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy sessions

Other

Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy

Primary outcomes

  1. Change from baseline bleeding frequency after treatment and at 5 months

    Time frame: Screening visit, within the first seven days after treatment and after five months follow-up visit

    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.

  2. Change from baseline joint pain of ankle after treatment and at 5 months

    Time frame: Screening visit, within the first seven days after treatment and after five months follow-up visit

    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).

  3. Change from baseline joint function after treatment and at 5 months

    Time frame: Screening visit, within the first seven days after treatment and after five months follow-up visit

    Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).

  4. Change from baseline range of motion after treatment and at 5 months

    Time frame: Screening visit, within the first seven days after treatment and after five months follow-up visit

    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

Secondary outcomes

  1. Age

    Time frame: Screening visit

    Age of patients

  2. Weight

    Time frame: Screening visit

    Weight of patients included in the study

  3. Height

    Time frame: Screening visit

    Height of patients

Sponsors and collaborators

Lead sponsor

Real Fundación Victoria Eugenia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2016
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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