- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406519
Evaluation of Static Postural Balance in Children With Hemophilia and Its Relationship With Joint Health
Static Postural Balance Evaluation in Children With Severe Haemophilia and Investigation of Its Relationship With Joint Health: a Cross-sectional Study
Study Overview
Status
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 investigator's 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bardakcı
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Van, Bardakcı, Turkey, 65090
- Yuzuncu Yil University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 6 to 18 years
- Participants do not perform regular physical activity and sports.
- For hemophilia group who developed hemophilic arthropathy in at least one of the lower limb joints due to severe hemophilia (total lower limb hemophilia joint health score ≥3).
- For hemophilia group patients to be receiving prophylaxis but have no major bleeding that could affect the musculoskeletal system in the past two weeks
Exclusion Criteria:
- Have any auditory and visual impairment
- Undergo any orthopedic injuries including lower limb
- Have any neurological or cognitive disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hemophilia Group
The inclusion criteria in the hemophilia group were as follows; patients aged 6 to 18 years who developed HA in at least one of the lower limb joints due to severe haemophilia (total lower limb HJHS ≥3); to be receiving prophylaxis but have no major bleeding that could affect the musculoskeletal system in the past two weeks; and who did not perform regular physical activity and sports.
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Control Group
The control group was consisted of healthy peers.
The exclusion criteria in the control group were as follows: who had any auditory and visual impairment; who underwent orthopedic injuries including lower limb; and who had any neurological or cognitive impairment that could affect balance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Hemophilia Joint Health Score
Time Frame: 1 month
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The score for each index-joint range from 0 to 20 and the lower limb joint score from 0 to 80.
A high score indicates that the joint health is worse.
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1 month
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Center of Pressure (CoP)- CoPX and CoPY
Time Frame: 1 month
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Amplitude of CoP is the difference between the biggest and smallest CoP displacement for X-axis (CoPX) and Y-axis (CoPY), the smaller the score, the better the postural stability.
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1 month
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Velocity- Mediolateral (MLV) and Anteroposterior (APV)
Time Frame: 1 month
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The velocity is calculated by dividing the CoP excursion by trial time and expressed in mm/sec.
It reflects the effectiveness of the postural stability- the bigger the velocity indicates the worse the postural control.
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1 month
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Standard deviation of body sway- Mediolateral (MLSD) and Anteroposterior (APSD)
Time Frame: 1 month
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The lower standard deviation in the body sway indicates that the postural balance is well.
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1 month
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Ellipse Area
Time Frame: 1 month
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%90 of the total area scanned in the mediolateral and anteroposterior direction is calculated using an ellipse.
A high score indicates that postural balance is worse
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1 month
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Perimeter
Time Frame: 1 month
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Quantifies the size of the displacement based upon the total distance scanned in mm, and the higher the length of the scanned area considered that postural stability is poor
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1 month
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Muscle strength
Time Frame: 1 month
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The flexors and extensors of the knee were measured by giving the resistance from proximal malleoli when the hip and knee were in 90° flexion during sitting position.
The dorsi and plantar flexors of ankle were measured in the lower limb stabilized in supine position, giving resistance from the proximal of the metatarsophalangeal joint and was recorded in pounds.
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1 month
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Standard deviation of the trunk
Time Frame: 1 month
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Total,anteroposterior and mediolateral standard deviation of the trunk were measured in degrees by the sensors.
The lower standard deviation in the trunk sway indicates that the postural balance is well.
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmet Fayik Oner, Prof., Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology
- Study Director: Kamuran Karaman, Assoc. Prof., Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology
- Principal Investigator: Seyhmus Kaplan, Assoc. Prof., Van Yuzuncu Yil University Faculty of Medicine Dept of Sports Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Necmettin Erb. Physiotherapy-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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