HemophiliaNCT04406519
Evaluation of Static Postural Balance in Children With Hemophilia and Its Relationship With Joint Health
An observational study of Hemophilia and Arthropathy of Knee, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Hemophilia is a rare hematological disorder characterized by a partial or complete deficiency of clotting factor VIII or IX.Bleeding disorders mainly affect the musculoskeletal system. Read more about this study
- Who is it for?
- Ages 6 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia, Arthropathy of Knee, Arthropathy of Ankle or Foot
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 15 May 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 6 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Hemophilic children in Van province
Who may be able to join
- 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
Who cannot join
- Have any auditory and visual impairment
- Undergo any orthopedic injuries including lower limb
- Have any neurological or cognitive disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Static Postural Balance Evaluation in Children With Severe Haemophilia and Investigation of Its Relationship With Joint Health: a Cross-sectional Study
Hemophilia is a rare hematological disorder characterized by a partial or complete deficiency of clotting factor VIII or IX.Bleeding 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 unclear.In the relationship between the clinical evaluation of hemophilia and postural balance, there is little research in the literature.
Read the 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.
- Keywords
- haemophilia, balance, joint health, arthropathy, children
- Medical subject headings
- Hemophilia A, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemophilia Joint Health Score
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.
Measured: 1 month
Center of Pressure (CoP)- CoPX and CoPY
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.
Measured: 1 month
Velocity- Mediolateral (MLV) and Anteroposterior (APV)
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.
Measured: 1 month
Standard deviation of body sway- Mediolateral (MLSD) and Anteroposterior (APSD)
The lower standard deviation in the body sway indicates that the postural balance is well.
Measured: 1 month
Ellipse Area
%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
Measured: 1 month
Perimeter
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
Measured: 1 month
Muscle strength
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.
Measured: 1 month
Standard deviation of the trunk
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Feb 2018
- Primary completion1 Jul 2018
- Study completion15 May 2019
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.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necati Muhammed TAT, Necmettin Erbakan University
- Investigators
- Ahmet Fayik Oner, Prof., Study chair, Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric HematologyKamuran Karaman, Assoc. Prof., Study director, Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric HematologySeyhmus Kaplan, Assoc. Prof., Principal investigator, Van Yuzuncu Yil University Faculty of Medicine Dept of Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406519
- Sponsor's protocol ID
- Necmettin Erb. Physiotherapy-3
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static Postural Balance Evaluation in Children With Severe Haemophilia and Investigation of Its Relationship With Joint Health: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04406519
- Acronym / sponsor ID
- Necmettin Erb. Physiotherapy-3
- Keywords
- haemophilia, balance, joint health, arthropathy, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 28 May 2020 (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 is a rare hematological disorder characterized by a partial or complete deficiency of clotting factor VIII or IX.Bleeding 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 unclear.In 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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Hemophilic children in Van province
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have any auditory and visual impairment
- Undergo any orthopedic injuries including lower limb
- Have any neurological or cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemophilia Joint Health Score
Time frame: 1 month
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.
Center of Pressure (CoP)- CoPX and CoPY
Time frame: 1 month
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.
Velocity- Mediolateral (MLV) and Anteroposterior (APV)
Time frame: 1 month
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.
Standard deviation of body sway- Mediolateral (MLSD) and Anteroposterior (APSD)
Time frame: 1 month
The lower standard deviation in the body sway indicates that the postural balance is well.
Ellipse Area
Time frame: 1 month
%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
Perimeter
Time frame: 1 month
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
Muscle strength
Time frame: 1 month
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.
Standard deviation of the trunk
Time frame: 1 month
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.
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 28 May 2020.
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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.
Ahmet Fayik Oner, Prof. study chair
Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology
Kamuran Karaman, Assoc. Prof. study director
Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology
Seyhmus Kaplan, Assoc. Prof. principal investigator
Van Yuzuncu Yil University Faculty of Medicine Dept of Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia and Arthropathy of Knee, run by Necmettin Erbakan 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 4 inclusion and 3 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 28 May 2020. 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?
Hemophilia Joint Health Score (time frame: 1 month). The study lists 8 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 28 May 2020.