Posture Analysis for Patients With Haemophilia

NCT05173129 | Completed

• 1 other identifier: 109/61
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

haemophilia; posture; anti-gravity muscles; joint health

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (1)

• Haemophilia Joint Health Score

  Baseline

Study Arms (2)

Haemophilic boys

EXPERIMENTAL

Adolescent boys with haemophilia

Diagnostic Test: Posture Analysis

Healthy boys

ACTIVE COMPARATOR

Healthy adolescent boys

Diagnostic Test: Posture Analysis

Interventions

Posture Analysis DIAGNOSTIC_TEST

Posture analysis and assessment of mechanical properties of posture muscles

Haemophilic boys; Healthy boys

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia A; Muscular Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Nevin A Guzel, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: cross-sectional study for two groups

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 29, 2021
• Study Start: September 1, 2021
• Primary Completion: January 15, 2022
• Study Completion: February 15, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)