- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02165462
Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy (PROPRIO-HE)
Assessment of Bilateral Deficit Phenomenon During Dynamic Plantar Flexion Task 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.
Study Overview
Detailed Description
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Murcia, Spain, 30107
- UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with haemophilia
Assessment of bilateral deficit phenomenon during dynamic plantar flexion task
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Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Bilateral Index of Maximal Peak Force
Time Frame: Screening visit
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Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).
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Screening visit
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Assessment of Bilateral Index of Rate of Development During the Preparation Phase
Time Frame: Screening visit
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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)
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Screening visit
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Assessment of Bilateral Index of Rate of Development During the Acceleration Phase
Time Frame: Screening visit
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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)
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Screening visit
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Assessment of Maximal Peak Force
Time Frame: Screening visit
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Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
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Screening visit
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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)
|
Screening visit
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Change of Joint Condition Based on Clinical Assessment
Time Frame: Screening visit
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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) |
Screening visit
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Assessment of Rate of Development During the Acceleration Phase
Time Frame: Screening visit
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Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
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Screening visit
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Assessment of Maximal Velocity of Movement
Time Frame: Screening visit
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Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
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Screening visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight of the Patients With Haemophilia
Time Frame: Screening visit
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The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)
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Screening visit
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Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)
Time Frame: Screening visit
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Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).
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Screening visit
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Joint Bleeding Before the Assessment
Time Frame: Screening visit
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Screening visit
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Height of the Patients With Haemophilia
Time Frame: Screening visit
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The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).
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Screening visit
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Body Mass Index of Patients With Haemophilia
Time Frame: Screening visit
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The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).
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Screening visit
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Age of Patients With Haemophilia
Time Frame: Screening visit
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Screening visit
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Collaborators and Investigators
Investigators
- Study Chair: JUAN JOSE RODRIGUEZ, MsC, Universidad Católica San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROPRIO-HE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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