Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy

NCT02165462 | Completed Results

• 1 other identifier: PROPRIO-HE
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia

Keywords

Haemophilia; Arthropathy; Bilateral deficit phenomenon; Proprioception

Outcome Measures

Primary Outcomes (8)

• Assessment of Bilateral Index of Maximal Peak Force

  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

  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

  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

  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

  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

  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

  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

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

  Screening visit

Secondary Outcomes (6)

• Weight of the Patients With Haemophilia

  Screening visit

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

  Screening visit

• Joint Bleeding Before the Assessment

  Screening visit

• Height of the Patients With Haemophilia

  Screening visit

• Body Mass Index of Patients With Haemophilia

  Screening visit

Study Arms (1)

Patients with haemophilia

Assessment of bilateral deficit phenomenon during dynamic plantar flexion task

Other: Patients with haemophilia

Interventions

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)

Patients with haemophilia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with haemophilia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio, Murcia

Murcia, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Hemophilia A; Joint Diseases

Interventions

hydroxyethyl methacrylate

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases

Results Point of Contact

• Title: Rubén Cuesta-Barriuso, PhD
• Organization: Universidad Católica San Antonio de Murcia

ruben.cuestab@gmail.com

+34 913146508

Study Officials

• JUAN JOSE RODRIGUEZ, MsC

  Universidad Católica San Antonio

  STUDY CHAIR

• RUBEN CUESTA-BARRIUSO, PhD

  Universidad Católica San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 17, 2014
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 28, 2016
• Results First Posted: December 15, 2015

Record last verified: 2015-09

Locations

ES (1)