HemophiliaPROPRIO-HENCT02165462

Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy

An observational study of Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 to 50 years, men only
Conditions the study is for: Hemophilia
What is being tested?: Patients with haemophilia
How many people: 17 participants
Where: 1 siteSpain
Study dates: Sep 2015to Oct 2015
How long will I take part?: 1 Month
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
No healthy volunteers
Adult

Study population: Patients with haemophilia

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad Católica San Antonio, Murcia
Murcia, Murcia, 30107

Other trials in Spain

About this study

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

Bookmark the relationship between clinical history of joint bleeds and clinical manifestations in standing and walking.

Read the 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.

Conditions: Hemophilia
Being tested: Patients with haemophilia
Keywords: Haemophilia, Arthropathy, Bilateral deficit phenomenon, Proprioception
Medical subject headings: Hemophilia A, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02165462
Study group	Role	What they receive
Patients with haemophilia		Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Receives: Other: Patients with haemophilia

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Screening visit

Secondary outcomes (6)

Weight of the Patients With Haemophilia
The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)
Measured: Screening visit
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).
Measured: Screening visit
Joint Bleeding Before the Assessment
Measured: Screening visit
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).
Measured: Screening visit
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).
Measured: Screening visit
Age of Patients With Haemophilia
Measured: Screening visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Oct 2015

First posted17 Jun 2014 (estimated)
Study startSep 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HemophiliaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 17 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT02165462
Sponsor's protocol ID: PROPRIO-HE
Acronym: PROPRIO-HE
Status last verified: Sep 2015
First submitted: 1 Jun 2014
Last updated: 28 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

All Hemophilia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Bilateral Deficit Phenomenon During Dynamic Plantar Flexion Task in Patients With Haemophilic Arthropathy
ClinicalTrials.gov ID: NCT02165462
Acronym / sponsor ID: PROPRIO-HE / PROPRIO-HE
Conditions: Hemophilia
Keywords: Haemophilia, Arthropathy, Bilateral deficit phenomenon, Proprioception
Study type: Observational
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Universidad Católica San Antonio de MurciaUniversity, hospital or other
Study start: Sep 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 17 Jun 2014 (estimated)
Results: Posted 15 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 1

Arm	Type	Receives
Patients with haemophilia	–	Other: Patients with haemophiliaAssessment of bilateral deficit phenomenon during dynamic plantar flexion task

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Patients with haemophilia

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patients with haemophiliaAssessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)	Other	Patients with haemophilia

Primary outcome

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).
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)
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)
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)
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)
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)
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)
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)

6 secondary outcomes

Weight of the Patients With Haemophilia
Time frame: Screening visit
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)
Time frame: Screening visit
Joint Bleeding Before the Assessment
Time frame: Screening visit
Height of the Patients With Haemophilia
Time frame: Screening visit
Body Mass Index of Patients With Haemophilia
Time frame: Screening visit
Age of Patients With Haemophilia
Time frame: Screening visit

Results and safety

Results posted to the registry on 15 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Haemophilia	17	17

Primary outcome: Assessment of Bilateral Index of Maximal Peak Force

Time frame: Screening visit. Mean (Standard Deviation). Unit: percentage

Measure	Patients With Haemophilia n = 17
Value	-40.86 (4.24)

Population analysed: Bilateral rates was calculated during the preparation phase and during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions. Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "\[100x (bilateral) / (right unilateral + left unilateral)\] - 100"

Primary outcome: Assessment of Bilateral Index of Rate of Development During the Preparation Phase

Time frame: Screening visit. Mean (Standard Deviation). Unit: percentage

Measure	Patients With Haemophilia n = 17
Value	31.34 (56.42)

Population analysed: Bilateral rates was calculated during the preparation phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "\[100x (bilateral) / (right unilateral + left unilateral)\] - 100"

Primary outcome: Assessment of Bilateral Index of Rate of Development During the Acceleration Phase

Time frame: Screening visit. Mean (Standard Deviation). Unit: percentage

Measure	Patients With Haemophilia n = 17
Value	20.05 (38.20)

Population analysed: Bilateral rates was calculated during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "\[100x (bilateral) / (right unilateral + left unilateral)\] - 100"

Primary outcome: Assessment of Maximal Peak Force

Time frame: Screening visit. Mean (Standard Deviation). Unit: N/kg

Measure	Patients With Haemophilia n = 17
Value	15.67 (1.36)

Population analysed: The maximum peak force (MPF) is defined as the maximum achieved in the force-time curve during the dynamic test plantar flexion for both bilateral conditions as right and left unilateral, normalized to body weight of the participants (N / kg value)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Haemophilia	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemophilia

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

JUAN JOSE RODRIGUEZ, MsC study chair

Universidad Católica San Antonio

RUBEN CUESTA-BARRIUSO, PhD principal investigator

Universidad Católica San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Bilateral Index of Maximal Peak Force (time frame: Screening visit). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02165462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.