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NCT Number: NCT02165462

Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy

Trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients with haemophilic arthropathy Describe the differences in terms of the physical variables (muscular strength, range of motion and proprioception) in patients with hemophilia who have conducted a home treatment with a digital tool.

Bookmark the relationship between clinical history of joint bleeds and clinical manifestations in standing and walking.

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Key information

Conditions

Hemophilia 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

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Universidad Católica San Antonio, Murcia

Murcia, 30107, Spain

About this study

  • Assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients with haemophilic arthropathy.
  • Indicate the independent variables that influence the development of strength and contractile activity, with or without previous joint bleeds in haemophilia patients with minors.
  • Observe the descriptive variables people influence the standing, the incorporation from sitting and jumping.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with hemophilia A and B.
  • With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
  • In prophylactic regimen with FVIII / FIX concentrates .
  • Residents in the Autonomous Community of the Region of Murcia.

Exclusion criteria

  • Patients without walking ability.
  • Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
  • Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
  • Patients whose parents or guardians have not signed the informed consent document.

Treatment and study plan

Patients with haemophilia

Other

Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Primary outcomes

  1. Assessment of Bilateral Index of Maximal Peak Force

    Time frame: Screening visit

    Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).

  2. Assessment of Bilateral Index of Rate of Development During the Preparation Phase

    Time frame: Screening visit

    Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

  3. Assessment of Bilateral Index of Rate of Development During the Acceleration Phase

    Time frame: Screening visit

    Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

  4. Assessment of Maximal Peak Force

    Time frame: Screening visit

    Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

  5. Assessment of Rate of Development During the Preparation Phase

    Time frame: Screening visit

    Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

  6. Change of Joint Condition Based on Clinical Assessment

    Time frame: Screening visit

    Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage).

    The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4)

  7. Assessment of Rate of Development During the Acceleration Phase

    Time frame: Screening visit

    Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

  8. Assessment of Maximal Velocity of Movement

    Time frame: Screening visit

    Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Secondary outcomes

  1. Weight of the Patients With Haemophilia

    Time frame: Screening visit

    The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)

  2. Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)

    Time frame: Screening visit

    Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).

  3. Joint Bleeding Before the Assessment

    Time frame: Screening visit

  4. Height of the Patients With Haemophilia

    Time frame: Screening visit

    The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).

  5. Body Mass Index of Patients With Haemophilia

    Time frame: Screening visit

    The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).

  6. Age of Patients With Haemophilia

    Time frame: Screening visit

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Assessment of Bilateral Deficit Phenomenon During Dynamic Plantar Flexion Task in Patients With Haemophilic Arthropathy

Acronym: PROPRIO-HE

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2014
Registry last updated
Jul 28, 2016

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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