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Completed

NCT Number: NCT05173129

Posture Analysis for Patients With Haemophilia

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.

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Muscle Disorder Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Postural; Defect

Age range

10 year–19 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, 01100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescent boys with haemophilia A or haemophilia B (for experimental group) and healthy adolescent boys (for control group).

Exclusion criteria

  • 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%

Treatment and study plan

Posture Analysis

Diagnostic Test

Posture analysis and assessment of mechanical properties of posture muscles

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Haemophilia Joint Health Score

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Comparison of Posture and Muscle Stiffness of Adolescent Boys With Haemophilia and Those of Age-matched Healthy Peers: a Controlled Cross-sectional Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2021
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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