NCT07243912

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 14, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

hemophiliapostural balancemusculoskeletal diseasephysical activitykinesiophobia

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to at 4 weeks

Secondary Outcomes (3)

  • Joint Health

    From enrollment to 4 weeks

  • Physical Activity Level

    From enrollment to 4 weeks

  • Kinesiophobia

    From enrollment to 4 weeks

Study Arms (2)

Control Group

Healthy individual

Diagnostic Test: Postural balance assessment

Hemophilia Group

Adults with Hemophilia

Diagnostic Test: Postural balance assessment

Interventions

Static and dynamic balance was analyzed with the posturographic platform.

Control GroupHemophilia Group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSince hemophilia is a hereditary disease seen in males, only males were included in the control group.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hemophilia patients and healthy volunteers

You may qualify if:

  • Severe or moderate hemophilia A or B

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia AMusculoskeletal DiseasesMotor ActivityKinesiophobia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehaviorPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Ayşe M Tat, Asst Prof

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 24, 2025

Study Start

September 10, 2025

Primary Completion

October 10, 2025

Study Completion

October 20, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations