Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy (PROPRIO-HE)

June 29, 2016 updated by: Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia

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

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Murcia, Spain, 30107
        • UNIVERSIDAD CATÓLICA SAN ANTONIO, MURCIA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients with haemophilia

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

Screening visit
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)
Screening visit
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)
Screening visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Screening visit
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).
Screening visit
Joint Bleeding Before the Assessment
Time Frame: Screening visit
Screening visit
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).
Screening visit
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).
Screening visit
Age of Patients With Haemophilia
Time Frame: Screening visit
Screening visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: JUAN JOSE RODRIGUEZ, MsC, Universidad Católica San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 1, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

September 1, 2015

More Information

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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