HemophiliaHE-BALANCENCT02165592
Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia
An observational study of Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region of Murcia. Describe the periarticular muscular deficit of the lower limbs, depending on the degree of injury: acute and chronic, or subacute. Read more about this study
- Who is it for?
- Ages 6 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Oct 2015
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 70 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients from the Murcia Regional Hemophilia Association
Who may be able to join
- Patients with hemophilia A and B
- Patients of all ages (from 6 to 70 years).
- With or without joint damage clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
- Residents in the Autonomous Community of the Region of Murcia.
Who cannot join
- Patients without ambulation
- Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
Trial locations and contacts
1 site in 1 country.
RUBÉN CUESTA-BARRIUSO, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Universidad Católica San Antonio, Murcia
Murcia, Murcia, 30107
JUAN JOSÉ RODRÍGUEZ JUAN, MsC
About this study
Official title: Assessment and Identification of Proprioceptive and Functional Changes in Patients With Hemophilia of the Region of Murcia.
Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region of Murcia.
- Describe the periarticular muscular deficit of the lower limbs, depending on the degree of injury: acute and chronic, or subacute.
- Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.
- Detect the biomechanical changes of the lower limbs and their impact on gait in patients with hemophilia.
- Assess the factors that influence the perception of illness and quality of life of patients with hemophilia.
Read the detailed description
Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis in lower limbs.
Descriptive study of alterations in the strength of the periarticular muscles of lower limbs as a result of acute conditions or the development of chronic articular sequelae.
Descriptive study of the biomechanical alterations in weight-bearing joints of lower limbs and their impact on gait in patients with hemophilia.
Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Arthropathy, Range of Motion, Strength, Proprioception, Gait, Quality of Life
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hemophilia | Patients with hemophilia who meet the inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the range of motion
Assess the range of motion of elbow, knee and ankle (using a goniometric evaluation).
Measured: Screening visit
Assess the muscular strength
Assess the muscular strength of arm, thigh and leg (through measurement of muscle balance).
Measured: Screening visit
Assess the joint pain
Joint pain (VAS scale with the use of a pressure algometer).
Measured: Screening visit
Assess the variables of strength
Assessment of variables of vertical strength, medio-lateral and anterior-posterior in jump and incorporation from the sitting position.
Measured: Screening visit
Assess the peak force
Functional assessment of peak force, force production per unit time and subsequent stabilization in standing (in jump and in the passage from the sitting position to standing position, respectively, using a force platform).
Measured: Screening visit
Assess the contractile activity
Assessment of miotendinous contractile activity in the patellar tendon and Achilles, in jump (CMJ-stiffness test).
Measured: Screening visit
Assess the state joint
State joint (applying Hemophilia Joint Health Score questionnaire).
Measured: Screening visit
Assess the list of activities
List of activities in hemophilia (completing the autocuestionario Hemophilia Activities List).
Measured: Screening visit
Assess the physical performance
Perception of physical performance (with the HEP-Test-Q questionnaire)
Measured: Screening visit
Assess the health Profile
Health Profile (using the scale Nottingham health profile)
Measured: Screening visit
Assess the quality of life
Quality of life (using the SF-36 and Haemo-QoL-36 questionnaire).
Measured: Screening visit
Secondary outcomes (3)
Age, sex, weight of the patients with hemophilia
Measured: Screening visit
Diagnosis, severity of hemophilia, type of treatment (prophylactic or on-demand) and inhibitors
Measured: Screening visit
Frequency of joint bleeds in the previous month and bleeding during the assessment
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165592
- Sponsor's protocol ID
- UCAM-2
- Other IDs
- UCAM-2
- Acronym
- HE-BALANCE
- Status last verified
- Sep 2015
- First submitted
- 13 Jun 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Identification of Proprioceptive and Functional Changes in Patients With Hemophilia of the Region of Murcia.
- ClinicalTrials.gov ID
- NCT02165592
- Acronym / sponsor ID
- HE-BALANCE / UCAM-2
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Arthropathy, Range of Motion, Strength, Proprioception, Gait, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (estimated)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region of Murcia.
- Describe the periarticular muscular deficit of the lower limbs, depending on the degree of injury: acute and chronic, or subacute.
- Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.
- Detect the biomechanical changes of the lower limbs and their impact on gait in patients with hemophilia.
- Assess the factors that influence the perception of illness and quality of life of patients with hemophilia.
Detailed description
Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis in lower limbs.
Descriptive study of alterations in the strength of the periarticular muscles of lower limbs as a result of acute conditions or the development of chronic articular sequelae.
Descriptive study of the biomechanical alterations in weight-bearing joints of lower limbs and their impact on gait in patients with hemophilia.
Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hemophilia | – | –Patients with hemophilia who meet the inclusion criteria |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the Murcia Regional Hemophilia Association
Key inclusion criteria (4 listed)
- Patients with hemophilia A and B
- Patients of all ages (from 6 to 70 years).
- With or without joint damage clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
- Residents in the Autonomous Community of the Region of Murcia.
Key exclusion criteria (3 listed)
- Patients without ambulation
- Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the range of motion
Time frame: Screening visit
Assess the range of motion of elbow, knee and ankle (using a goniometric evaluation).
Assess the muscular strength
Time frame: Screening visit
Assess the muscular strength of arm, thigh and leg (through measurement of muscle balance).
Assess the joint pain
Time frame: Screening visit
Joint pain (VAS scale with the use of a pressure algometer).
Assess the variables of strength
Time frame: Screening visit
Assessment of variables of vertical strength, medio-lateral and anterior-posterior in jump and incorporation from the sitting position.
Assess the peak force
Time frame: Screening visit
Functional assessment of peak force, force production per unit time and subsequent stabilization in standing (in jump and in the passage from the sitting position to standing position, respectively, using a force platform).
Assess the contractile activity
Time frame: Screening visit
Assessment of miotendinous contractile activity in the patellar tendon and Achilles, in jump (CMJ-stiffness test).
Assess the state joint
Time frame: Screening visit
State joint (applying Hemophilia Joint Health Score questionnaire).
Assess the list of activities
Time frame: Screening visit
List of activities in hemophilia (completing the autocuestionario Hemophilia Activities List).
Assess the physical performance
Time frame: Screening visit
Perception of physical performance (with the HEP-Test-Q questionnaire)
Assess the health Profile
Time frame: Screening visit
Health Profile (using the scale Nottingham health profile)
Assess the quality of life
Time frame: Screening visit
Quality of life (using the SF-36 and Haemo-QoL-36 questionnaire).
3 secondary outcomes
Age, sex, weight of the patients with hemophilia
Time frame: Screening visit
Diagnosis, severity of hemophilia, type of treatment (prophylactic or on-demand) and inhibitors
Time frame: Screening visit
Frequency of joint bleeds in the previous month and bleeding during the assessment
Time frame: Screening visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
RUBÉN CUESTA-BARRIUSO, PhD contact
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 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RUBÉN CUESTA-BARRIUSO, PhD (rcuesta@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the range of motion (time frame: Screening visit). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2015.