- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243912
Balance Evaluation in Adult Hemophilia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Tuşba
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Van, Tuşba, Turkey (Türkiye), 65080
- Van Yuzuncu Yıl University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Severe or moderate hemophilia A or B
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Control Group
Healthy individual
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Static and dynamic balance was analyzed with the posturographic platform.
|
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Hemophilia Group
Adults with Hemophilia
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Static and dynamic balance was analyzed with the posturographic platform.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From enrollment to at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint Health
Time Frame: From enrollment to 4 weeks
|
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.
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From enrollment to 4 weeks
|
|
Physical Activity Level
Time Frame: From enrollment to 4 weeks
|
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.
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From enrollment to 4 weeks
|
|
Kinesiophobia
Time Frame: From enrollment to 4 weeks
|
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
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From enrollment to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşe M Tat, Asst Prof, Yuzuncu Yil University
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
Additional Relevant MeSH Terms
- Mental Disorders
- Genetic Diseases, Inborn
- Hematologic Diseases
- Blood Coagulation Disorders
- Hemorrhagic Disorders
- Blood Coagulation Disorders, Inherited
- Coagulation Protein Disorders
- Phobic Disorders
- Anxiety Disorders
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Behavior
- Hemic and Lymphatic Diseases
- Kinesiophobia
- Hemophilia A
- Musculoskeletal Diseases
- Motor Activity
Other Study ID Numbers
- YuzuncuYil2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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