NCT07851922

Brief Summary

Recurrent joint bleeding (hemarthrosis) occurs in 70-80% of cases of hemophilia. The three most frequently affected joints are the synovial joints of the ankle, knee, and elbow. Among these, the ankle and knee are the most common sites of bleeding, accounting for 80% of cases (Stephensen et al., 2009). This susceptibility stems from factors such as the fact that the knee and ankle are weight-bearing joints and are highly exposed to trauma. Hemophilia treatment aims to reduce the frequency of bleeding episodes through prophylactic factor replacement; however, joint bleeding can recur despite treatment, potentially leading to permanent joint damage. This joint disease causes pain, reduced range of motion, and potential impairment of postural balance, while also increasing the risk of falls. Due to its complexity and significance for the individual, gait assessment is a crucial component in evaluating mobility, functional capacity, and rehabilitation progress across various populations, including the elderly, individuals with neurological disorders, and those recovering from injuries. Various clinical tests and technological tools are available to measure different aspects of gait, such as walking ability, endurance, adaptability, and fatigue. Timed walking tests-such as the Timed Up and Go (TUG) test, the 2-Minute Walk Test (2MWT), the 6-Minute Walk Test (6MWT), the 10-Meter Walk Test (10MWT), and the Timed 25-Foot Walk Test (T25FW)-measure gait speed, endurance, and overall walking ability. A common feature of these tests is that they involve walking along a straight path with little to no change in direction; while this makes them effective in standardized clinical settings, they are relatively less suitable for assessing the complex mobility demands of daily life. In contrast, the Figure-8 Walk Test (F8WT) requires continuous changes in direction and turning, thereby challenging anticipatory postural adjustments, spatial navigation, and motor planning. Literature has demonstrated that walking along a curved path challenges dynamic balance and increases gait variability, revealing deficits-particularly in the elderly and in individuals with neurological or cognitive impairments-that are not apparent during straight-line walking. In their daily lives, people frequently encounter curved paths and changes in walking direction-such as walking around a table, turning a corner, or avoiding an obstacle. The ability to successfully adapt one's gait and safely execute turns or changes in direction is fundamental to an individual's mobility and independence. The Timed Up and Go (TUG) test is a widely used, performance-based clinical assessment tool for measuring lower-extremity function, mobility, and fall risk in individuals; its reliability and validity are well-established. The ABC scale is a 16-item measure used to assess balance confidence while performing specific activities both indoors and outdoors; it has also been proven reliable and valid. Among older adults, a score of 76% or lower indicates a risk of falling. The Weight-Bearing Lunge Test (WBLT), which assesses ankle dorsiflexion mobility, has demonstrated excellent test-retest reliability in patients with hemophilia, even in those with limited joint damage. Another test that is reliable and shows strong correlation with other functional measures in individuals with hemophilia is the Four Square Step Test (FSST). The FSST is associated with age rather than the severity of hemophilia and provides clinicians with information regarding the speed and ability to change direction and step over obstacles. The Y Balance Test (YBT) is a dynamic balance and postural control assessment that is increasingly preferred for use with patients with hemophilia in recent years. Since the F8WT requires continuous changes of direction, it demands greater dynamic balance, spatial planning, and gait adaptation. It is important to examine the validity and reliability of the F8WT-which assesses change of direction, dynamic balance, agility, and functional mobility-in patients with hemophilia. The fact that the F8WT is easy to administer, quick to complete, and requires minimal equipment offers significant advantages for clinical use. However, no study evaluating the psychometric properties of this test in patients with hemophilia has been found in the literature. The aim of this study is to investigate the test-retest reliability and construct validity of the F8WT and WBLT in adult patients with hemophilia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Aug 2026Oct 2026

Study Start

First participant enrolled

August 30, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Hemophiliaoutcome measuresvalidityFigure-of-eight walk testweight-bearing lunge test

Outcome Measures

Primary Outcomes (2)

  • Figure-of-eight walk

    The Figure-of-Eight Walk Test (F8WT) involves sitting on and rising from a chair. First, a rectangle measuring 3.6 meters in length and 2.4 meters in width is marked on the floor, and cones are placed at the two rear corners (along the length). A chair is positioned 2.4 meters away from the cones on either side, and the participant sits facing forward. Upon the start signal, the participant rises from the chair, walks clockwise around the rear-right cone as quickly as possible, returns to the chair, and sits down. Immediately afterward, they stand up, walk counter-clockwise around the rear-left cone, return to the chair, and sit down; this procedure is repeated twice, with an interval of 3-4 days between sessions.

    Two measurements: Baseline and another 3-4 days after baseline

  • Weight-Bearing Lunge

    In this test, participants stand barefoot facing a wall; the test foot is positioned parallel to a measuring tape fixed to the floor, while the opposite foot is placed one foot-length behind. Participants perform a forward lunge, lightly touching their kneecap against the wall while maintaining heel contact. The test foot is moved backward in increments of approximately 1 cm until heel contact can no longer be maintained, and the distance between the toes and the wall is recorded in centimeters. The lunge position will be used to measure ankle dorsiflexion.

    Two measurements: Baseline and another 3-4 days after baseline

Secondary Outcomes (7)

  • Timed Up and Go

    Two measurements: Baseline and another 3-4 days after baseline

  • Five Times Sit to Stand

    Two measurements: Baseline and another 3-4 days after baseline

  • Four Square Step Test

    Two measurements: Baseline and another 3-4 days after baseline

  • Activities-specific Balance Confidence Scale

    Two measurements: Baseline and another 3-4 days after baseline

  • Y-Balance Test

    Two measurements: Baseline and another 3-4 days after baseline

  • +2 more secondary outcomes

Study Arms (1)

Hemophilia

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemophilia patients aged with 18-65 years

You may qualify if:

  • a diagnosis of hemophilia A
  • severe, moderate or mild clinical severity of hemophilia
  • a history of bleeding in at least one knee or ankle joint
  • being aged 18-65
  • the ability to walk 20 meters independently without a cane or crutches

You may not qualify if:

  • inability to stand unsupported; presence of an orthopaedic, neurological, and/or psychiatric condition affecting balance or physical performance
  • visual impairment
  • inhibitor positivity
  • inability to bear weight through the lower extremities
  • major lower-extremity surgery within the previous 6 months
  • haemarthrosis within the previous 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Necati Muhammed TAT, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 1, 2026

Study Start

August 30, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations