Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04406519
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2020-05-20
Brief Title:
Evaluation of Static Postural Balance in Children With Hemophilia and Its Relationship With Joint Health
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
Static Postural Balance Evaluation in Children With Severe Haemophilia and Investigation of Its Relationship With Joint Health a Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hemophilia is a rare hematological disorder characterized by a partial or complete deficiency of clotting factor VIII or IXBleeding disorders mainly affect the musculoskeletal system Intra-articular bleeding is an important complication related to hemophilia and usually occurs in large synovial joints such as knees and ankles Initially these bleeds occur non-specific spontaneously and usually affect one joint and repeated bleeding makes that joint a target joint Postural balance can be defined as the ability to maintain a stable posture for maximum duration with minimal body sway or to hold the body centre of gravity CoG over its base support in varying conditions 1 Somatosensorial information from mechanoreceptors visual and vestibular receptors is required to maintain postural balance Postural balance is tried to be controlled by the postural adjustments provided by the contraction of the lower limb muscles and trunk muscles before perturbation Spontaneous hemarthrosis is a distinctive feature of severe haemophilia and that recurrent bleedings may likely to cause postural balance disorders by disrupting proprioceptive inputs from mechanoreceptors in the joint Data on how bleeding affects postural balance in children with hemophilia is unclearIn the relationship between the clinical evaluation of hemophilia and postural balance there is little research in the literature
Detailed Description:
The aim of this study was to investigate the changes in static postural balance parameters more reliably and comprehensively with a longer test duration and to reveal the relationship between balance parameters and joint health score in children with hemophilia The investigators hypothesis was that in children with hemophilia CwH postural balance was correlated with joint health status and had poor static postural balance compared to healthy peers
Twenty-one CwH aged 6 to 18 years who developed hemophilic arthropathy in at least one of the lower limb joints due to severe hemophilia and twenty-one healthy peers were included in the study
The Hemophilia Joint Health Score HJHS a valid and reliable test was used to measure the joint health in CwH Muscle strengths were measured with digital dynamometer The kinetic devices most commonly used to evaluate in the laboratory evaluation of postural balance are the force platform and are considered the gold standard method In the postural balance evaluation changes in the X and Y axis were used The amplitude of these changes the standard deviation of the displacement and the velocity were evaluated In addition the ellipse area and perimeter were measured
Twenty-one CwH aged 6 to 18 years who developed hemophilic arthropathy in at least one of the lower limb joints due to severe hemophilia and twenty-one healthy peers were included in the study
The Hemophilia Joint Health Score HJHS a valid and reliable test was used to measure the joint health in CwH Muscle strengths were measured with digital dynamometer The kinetic devices most commonly used to evaluate in the laboratory evaluation of postural balance are the force platform and are considered the gold standard method In the postural balance evaluation changes in the X and Y axis were used The amplitude of these changes the standard deviation of the displacement and the velocity were evaluated In addition the ellipse area and perimeter were measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None