Clinical trial NCT02165462: Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy
Official title: Assessment of Bilateral Deficit Phenomenon During Dynamic Plantar Flexion Task in Patients With Haemophilic Arthropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Keywords: Haemophilia
Arthropathy
Bilateral deficit phenomenon
Proprioception
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with haemophilia

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Bilateral Index of Maximal Peak Force
timeFrame: Screening visit
measure: Assessment of Bilateral Index of Rate of Development During the Preparation Phase
timeFrame: Screening visit
measure: Assessment of Bilateral Index of Rate of Development During the Acceleration Phase
timeFrame: Screening visit
measure: Assessment of Maximal Peak Force
timeFrame: Screening visit
measure: Assessment of Rate of Development During the Preparation Phase
timeFrame: Screening visit
measure: Change of Joint Condition Based on Clinical Assessment
timeFrame: Screening visit
measure: Assessment of Rate of Development During the Acceleration Phase
timeFrame: Screening visit
measure: Assessment of Maximal Velocity of Movement
timeFrame: Screening visit
Secondary outcomes:
measure: Weight of the Patients With Haemophilia
timeFrame: Screening visit
measure: Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)
timeFrame: Screening visit
measure: Joint Bleeding Before the Assessment
timeFrame: Screening visit
measure: Height of the Patients With Haemophilia
timeFrame: Screening visit
measure: Body Mass Index of Patients With Haemophilia
timeFrame: Screening visit
measure: Age of Patients With Haemophilia
timeFrame: Screening visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio, Murcia
Study officials:
affiliation: Universidad Católica San Antonio
name: JUAN JOSE RODRIGUEZ, MsC
role: STUDY_CHAIR
affiliation: Universidad Católica San Antonio
name: RUBEN CUESTA-BARRIUSO, PhD
role: PRINCIPAL_INVESTIGATOR
References: