Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy

Completed

• Conditions: Hemophilia
• Interventions: Other: Patients with haemophilia

• Registration Number: NCT02165462
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Study First Submitted: 2014-06-01
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Status Verified: 2015-09
• Study Start: 2015-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2015-10-07
• Results First Submitted QC: 2015-11-11
• Results First Posted: 2015-12-15
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with haemophilia	Patients with haemophilia	Assessment of bilateral deficit phenomenon during dynamic plantar flexion task

Primary Outcome Measures

Name	Time	Method
Assessment of Rate of Development During the Preparation Phase	Screening visit	Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Bilateral Index of Rate of Development During the Preparation Phase	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)
Assessment of Bilateral Index of Maximal Peak Force	Screening visit	Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).
Assessment of Bilateral Index of Rate of Development During the Acceleration Phase	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)
Assessment of Maximal Velocity of Movement	Screening visit	Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Maximal Peak Force	Screening visit	Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Change of Joint Condition Based on Clinical Assessment	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)
Assessment of Rate of Development During the Acceleration Phase	Screening visit	Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Secondary Outcome Measures

Name	Time	Method
Joint Bleeding Before the Assessment	Screening visit
Weight of the Patients With Haemophilia	Screening visit	The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)	Screening visit	Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).
Height of the Patients With Haemophilia	Screening visit	The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).
Body Mass Index of Patients With Haemophilia	Screening visit	The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).
Age of Patients With Haemophilia	Screening visit

Trial Locations

Locations (1)

Universidad Católica San Antonio, Murcia; 🇪🇸 Murcia, Spain