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Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

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ClinicalTrials.gov Identifier: NCT02825667
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Real Fundación Victoria Eugenia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Haemophilia Other: Physiotherapy sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : September 8, 2017
Actual Study Completion Date : September 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arm Intervention/treatment
Experimental: Experimental group

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

No Intervention: Control group
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).



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825667


Sponsors and Collaborators
Real Fundación Victoria Eugenia
Investigators
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Principal Investigator: Rubén Cuesta-Barriuso, PhD Real Fundación Victoria Eugenia
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Responsible Party: Real Fundación Victoria Eugenia
ClinicalTrials.gov Identifier: NCT02825667    
Other Study ID Numbers: AnHe-Fascial
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Real Fundación Victoria Eugenia:
Haemophilia
Ankle
Arthropathy
Pain
Range of motion
Myofascial techniques
Additional relevant MeSH terms:
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Joint Diseases
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Musculoskeletal Diseases