Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy

Hemophilia Clinical Trial

— PROPRIO-HE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165462
• Other study ID #: PROPRIO-HE
• Status: Completed
• Phase: N/A
• First received: June 1, 2014
• Last updated: November 11, 2015
• Start date: September 2015
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemophilia
• Joint Diseases

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio, Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Weight of the Patients With Haemophilia	The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)	Screening visit	No
Secondary	Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)	Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).	Screening visit	No
Secondary	Joint Bleeding Before the Assessment		Screening visit	Yes
Secondary	Height of the Patients With Haemophilia	The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).	Screening visit	No
Secondary	Assess the Body Mass Index of Patients With Haemophilia	The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).	Screening visit	No
Secondary	Assess of the Aged to Patients With Haemophilia		Screening visit	No