Postural BalanceNCT07243912
Balance Evaluation in Adult Hemophilia
An observational study of Postural Balance, run by Ayse Merve TAT at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Recurrent hemarthrosis in hemophilia can cause deterioration of static and dynamic balance in hemophilia. Studies in AwH report decreased dynamic balance, but consistent results regarding static balance are lacking. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Postural balance assessment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2025to 20 Oct 2025
- How long will I take part?
- 7 Days
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hemophilia patients and healthy volunteers
Who may be able to join
- Severe or moderate hemophilia A or B
Who cannot join
- Diabetus mellitus, hemiplegia, rheumatoid arthritis, Alzheimer's disease, Parkinson's disease, all vestibular system pathologies, lower extremity surgery within the last 6 months, using a walking aid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Static and Dynamic Balance, and the Effects of Joint Health, Physical Activity and Kinesiophobia on Dynamic Balance in Adult With Hemophilia.
Introduction: Recurrent hemarthrosis in hemophilia can cause deterioration of static and dynamic balance in hemophilia. Studies in AwH report decreased dynamic balance, but consistent results regarding static balance are lacking. The causes of the decrease in dynamic balance and its associated parameters have been under explored.
Aim: To investigate static and dynamic balance in AwH compared to healthy controls and factors such as joint health, physical activity and kinesiophobia that may affect dynamic balance.
Methods: This cross-sectional controlled study included 41 AwH and 40 healthy controlled, totally 81 man and study groups determined as Hemophilia Group (HG) and Control Group (CG). Static (Static Stability Test) and dynamic balance (Limits of Stability Test (LoS) Test) were assessed Pro-kin Technobody Posturographic Platform; physical activity level with International Physical Activity Questionnaire (IPAQ) for all groups. Joint health and kinesiophobia were assessed with Hemophilia Joint Health Score and Tampa Scale for Kinesiophobia (TSK) for HG, respectively. Participants' age, height and weight were questioned in both groups, as well as type and severity of hemophilia, type of treatment, and work/job status in HG.
- Conditions
- Postural Balance
- Being tested
- Postural balance assessment
- Keywords
- hemophilia, postural balance, musculoskeletal disease, physical activity, kinesiophobia
- Medical subject headings
- Hemophilia A, Musculoskeletal Diseases, Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural balance assessmentDiagnostic test
Static and dynamic balance was analyzed with the posturographic platform.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Healthy individual Receives: Diagnostic Test: Postural balance assessment | |
| Hemophilia Group | Adults with Hemophilia Receives: Diagnostic Test: Postural balance assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static and Dynamic Balance Assessment
Static and dynamic balance assessments were performed using the Pro-kin Technobody Posturographic Platform (Pro-kin 212, Technobody s.r.l., Dalmine, 21044 Bergamo, Italy). Static balance was assessed using the "Static Stability Test." This test is based on the subject's oscillations on the force platform, assessing the movement of the center of pressure, and the trunk sensor measuring trunk oscillation. Dynamic balance will be assessed using the Limits of Stability test. For the LoS test, a medium difficulty level (20 levels) will be selected from the 5-10-20-30-40 difficulty levels. Participants will be asked to orient their center of gravity toward eight directional targets for a limited time.
Measured: From enrollment to at 4 weeks
Secondary outcomes (3)
Joint Health
This was assessed with Hemophilia Joint Health Score (HJHS). The HJHS evaluates the knee, elbow, and ankle index joints bilaterally and includes a walking score. Each joint can receive a maximum of 20 points, with a maximum walking score of 4 points (total score = 124). A higher score indicates poor joint health. Since the elbow joint score will not be used in this study, the maximum score was determined as 84.
Measured: From enrollment to 4 weeks
Physical Activity Level
Physical activity was evaluated with the International Physical Activity Questionnaire (IPAQ) Short Form. The IPAQ short form consists of seven questions to be answered by the patient and asks about the duration and frequency of each activity performed during the past week. The total score is calculated in MET-min/week by multiplying the MET values defined for walking (3.3 METs), moderate-intensity physical activity (4.0 METs), and vigorous-intensity physical activity (8.0 METs) by the duration (minutes) and frequency (days). Sitting is not included in the score. High scores indicate high physical activity.
Measured: From enrollment to 4 weeks
Kinesiophobia
Kinesiophobia will be assessed with the Tampa Scale for Kinesiophobia. Kinesiophobia is defined as the fear of reinjury and movement due to chronic pain. It consists of 17 questions, with total scores ranging 17-68. The higher the score is the gretaer the level of kinesiophobia, and scores above 37 are considered high kinesiophobia
Measured: From enrollment to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Sep 2025
- Primary completion10 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- 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
- 81 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Ayse Merve TAT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayse Merve TAT, Yuzuncu Yil University
- Investigators
- Ayşe M Tat, Asst Prof, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243912
- Sponsor's protocol ID
- YuzuncuYil2025
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Static and Dynamic Balance, and the Effects of Joint Health, Physical Activity and Kinesiophobia on Dynamic Balance in Adult With Hemophilia.
- ClinicalTrials.gov ID
- NCT07243912
- Acronym / sponsor ID
- YuzuncuYil2025
- Conditions
- Postural Balance
- Keywords
- hemophilia, postural balance, musculoskeletal disease, physical activity, kinesiophobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ayse Merve TATUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 24 Nov 2025 (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.
Introduction: Recurrent hemarthrosis in hemophilia can cause deterioration of static and dynamic balance in hemophilia. Studies in AwH report decreased dynamic balance, but consistent results regarding static balance are lacking. The causes of the decrease in dynamic balance and its associated parameters have been under explored.
Aim: To investigate static and dynamic balance in AwH compared to healthy controls and factors such as joint health, physical activity and kinesiophobia that may affect dynamic balance.
Methods: This cross-sectional controlled study included 41 AwH and 40 healthy controlled, totally 81 man and study groups determined as Hemophilia Group (HG) and Control Group (CG). Static (Static Stability Test) and dynamic balance (Limits of Stability Test (LoS) Test) were assessed Pro-kin Technobody Posturographic Platform; physical activity level with International Physical Activity Questionnaire (IPAQ) for all groups. Joint health and kinesiophobia were assessed with Hemophilia Joint Health Score and Tampa Scale for Kinesiophobia (TSK) for HG, respectively. Participants' age, height and weight were questioned in both groups, as well as type and severity of hemophilia, type of treatment, and work/job status in HG.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: Postural balance assessmentHealthy individual |
| Hemophilia Group | – | Diagnostic Test: Postural balance assessmentAdults with Hemophilia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hemophilia patients and healthy volunteers
Key inclusion criteria (1 listed)
- Severe or moderate hemophilia A or B
Key exclusion criteria (1 listed)
- Diabetus mellitus, hemiplegia, rheumatoid arthritis, Alzheimer's disease, Parkinson's disease, all vestibular system pathologies, lower extremity surgery within the last 6 months, using a walking aid.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural balance assessmentStatic and dynamic balance was analyzed with the posturographic platform. | Diagnostic test | Control Group, Hemophilia Group |
Primary outcome
Static and Dynamic Balance Assessment
Time frame: From enrollment to at 4 weeks
Static and dynamic balance assessments were performed using the Pro-kin Technobody Posturographic Platform (Pro-kin 212, Technobody s.r.l., Dalmine, 21044 Bergamo, Italy). Static balance was assessed using the "Static Stability Test." This test is based on the subject's oscillations on the force platform, assessing the movement of the center of pressure, and the trunk sensor measuring trunk oscillation. Dynamic balance will be assessed using the Limits of Stability test. For the LoS test, a medium difficulty level (20 levels) will be selected from the 5-10-20-30-40 difficulty levels. Participants will be asked to orient their center of gravity toward eight directional targets for a limited time.
3 secondary outcomes
Joint Health
Time frame: From enrollment to 4 weeks
Physical Activity Level
Time frame: From enrollment to 4 weeks
Kinesiophobia
Time frame: From enrollment to 4 weeks
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 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ayşe M Tat, Asst Prof principal investigator
Yuzuncu Yil University
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 Postural Balance, run by Ayse Merve TAT 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 1 inclusion and 1 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 24 Nov 2025. 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?
Static and Dynamic Balance Assessment (time frame: From enrollment to at 4 weeks). 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 24 Nov 2025.