HemophiliaNCT05173129
Posture Analysis for Patients With Haemophilia
A study testing Posture Analysis in people with Hemophilia and Postural; Defect, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Hemophilia A and B are inherited disorders characterized by deficient or missing coagulation factors VIII or IX, respectively, of which the main long-term clinical manifestation is joint damage. Patients with haemophilia (PwH) are susceptible to clinical joint bleeding that may cause irreversible joint damage. Read more about this study
- Who is it for?
- Ages 10 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia, Postural; Defect, Muscle Disorder
- What is being tested?
- Posture Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 15 Feb 2022
- Phase
- Interventional
- 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 10 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent boys with haemophilia A or haemophilia B (for experimental group) and healthy adolescent boys (for control group).
Who cannot join
- To be with another congenital coagulopathy such as von Willebrand syndrome.
- To be unable to stand without support due to hemophilic arthropathy.
- To be having another musculoskeletal problem.
- To be having factor VIII or IX level in the plasma above 6%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Posture and Muscle Stiffness of Adolescent Boys With Haemophilia and Those of Age-matched Healthy Peers: a Controlled Cross-sectional Study
Hemophilia A and B are inherited disorders characterized by deficient or missing coagulation factors VIII or IX, respectively, of which the main long-term clinical manifestation is joint damage. Patients with haemophilia (PwH) are susceptible to clinical joint bleeding that may cause irreversible joint damage. Some degree of damage may already occur after the first haemarthrosis or even in children who never experienced clinically evident joint bleeds. Joints are mechanical systems with a structure strictly related to functioning. Therefore, any alteration in structure may have an impact on function (starting from the primary level of posture and anti-gravity muscles), which might in turn stress the joints and increase the risk of bleeding.The primary aim of this study is to investigate the changes in posture and the mechanical properties of anti-gravity muscles of adolescent PwH. The secondary aim is to determine the effect of joint dysfunction on posture in adolescent PwH.
- Conditions
- Hemophilia, Postural; Defect, Muscle Disorder
- Being tested
- Posture Analysis
- Keywords
- haemophilia, posture, anti-gravity muscles, joint health
- Medical subject headings
- Hemophilia A, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture AnalysisDiagnostic test
Posture analysis and assessment of mechanical properties of posture muscles
| Study group | Role | What they receive |
|---|---|---|
| Haemophilic boys | Experimental | Adolescent boys with haemophilia Receives: Diagnostic Test: Posture Analysis |
| Healthy boys | Active comparator | Healthy adolescent boys Receives: Diagnostic Test: Posture Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photogrammetry
The photogrammetry is a single evaluation method based on the analysis of two-dimensional photographs with a software.The erect-static posture of the participants will be analyzed with photogrammetry method. Firstly, two-dimensional photographs of the participant in the static-erect position will be taken.Afterwards, spinal and extremity angles will be measured in degrees using Kinovea™ software in the two-dimensional photographs transferred to the computer.
Measured: Baseline
Myotonometric assessment
Myotonometric assessment is a reliable method in which the stiffness, elasticity and tone of the muscles are evaluated with a single measurement method.The mechanical properties (tone, stiffness, and elasticity) of the superficial muscles that affect posture will be evaluated with Myoton Pro™ device (Myoton AS, Tallinn, Estonia). With a single measurement made with Myoton Pro™ device, numerical values reflecting the mechanical properties of the muscle are obtained on the screen of the device.
Measured: Baseline
Secondary outcomes (1)
Haemophilia Joint Health Score
Joint health of adolescent patients with haemophilia will be assessed by Haemophilia Joint Health Score (HJHS). The HJHS, is calculated by adding the global gait score to the sum of 6 joint totals. The test could yield a minimum score of 0, which indicates healthy joint status, and a maximum score of 124 points (20 points per joint × 6+ 4 points for gait score), which indicates severe arthropathy in multiple joints
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Sep 2021
- Primary completion15 Jan 2022
- Study completion15 Feb 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cross-sectional study for two groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Deniz, PT, Cukurova University
- Investigators
- Nevin A Guzel, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173129
- Sponsor's protocol ID
- 109/61
- Status last verified
- Aug 2022
- First submitted
- 20 Nov 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posture and Muscle Stiffness of Adolescent Boys With Haemophilia and Those of Age-matched Healthy Peers: a Controlled Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05173129
- Acronym / sponsor ID
- 109/61
- Conditions
- Hemophilia, Postural; Defect, Muscle Disorder
- Keywords
- haemophilia, posture, anti-gravity muscles, joint health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 29 Dec 2021 (actual)
- 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.
Hemophilia A and B are inherited disorders characterized by deficient or missing coagulation factors VIII or IX, respectively, of which the main long-term clinical manifestation is joint damage. Patients with haemophilia (PwH) are susceptible to clinical joint bleeding that may cause irreversible joint damage. Some degree of damage may already occur after the first haemarthrosis or even in children who never experienced clinically evident joint bleeds. Joints are mechanical systems with a structure strictly related to functioning. Therefore, any alteration in structure may have an impact on function (starting from the primary level of posture and anti-gravity muscles), which might in turn stress the joints and increase the risk of bleeding.The primary aim of this study is to investigate the changes in posture and the mechanical properties of anti-gravity muscles of adolescent PwH. The secondary aim is to determine the effect of joint dysfunction on posture in adolescent PwH.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cross-sectional study for two groups
| Arm | Type | Receives |
|---|---|---|
| Haemophilic boys | Experimental | Diagnostic Test: Posture AnalysisAdolescent boys with haemophilia |
| Healthy boys | Active comparator | Diagnostic Test: Posture AnalysisHealthy adolescent boys |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent boys with haemophilia A or haemophilia B (for experimental group) and healthy adolescent boys (for control group).
Key exclusion criteria (4 listed)
- To be with another congenital coagulopathy such as von Willebrand syndrome.
- To be unable to stand without support due to hemophilic arthropathy.
- To be having another musculoskeletal problem.
- To be having factor VIII or IX level in the plasma above 6%
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 |
|---|---|---|
| Posture AnalysisPosture analysis and assessment of mechanical properties of posture muscles | Diagnostic test | Haemophilic boys, Healthy boys |
Primary outcome
Photogrammetry
Time frame: Baseline
The photogrammetry is a single evaluation method based on the analysis of two-dimensional photographs with a software.The erect-static posture of the participants will be analyzed with photogrammetry method. Firstly, two-dimensional photographs of the participant in the static-erect position will be taken.Afterwards, spinal and extremity angles will be measured in degrees using Kinovea™ software in the two-dimensional photographs transferred to the computer.
Myotonometric assessment
Time frame: Baseline
Myotonometric assessment is a reliable method in which the stiffness, elasticity and tone of the muscles are evaluated with a single measurement method.The mechanical properties (tone, stiffness, and elasticity) of the superficial muscles that affect posture will be evaluated with Myoton Pro™ device (Myoton AS, Tallinn, Estonia). With a single measurement made with Myoton Pro™ device, numerical values reflecting the mechanical properties of the muscle are obtained on the screen of the device.
1 secondary outcome
Haemophilia Joint Health Score
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Hemophilia
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A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
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A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
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A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
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Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia 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.
Nevin A Guzel, Prof. Dr. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posture Analysis in people with Hemophilia and Postural; Defect, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 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 5 Aug 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Photogrammetry (time frame: Baseline). The study lists 2 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 5 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.