Validity and Reliability of the Two-minute Step Test in Hemophilia

February 13, 2026 updated by: Tuğba GÖNEN, Hasan Kalyoncu University

Investigating the Validity and Reliability of the Two-minute Step Test in Patients With Hemophilia

The aim of our study was to evaluate the psychometric properties of the 2-minute step test in hemophilia patients, assess its intra-rater and inter-rater reliability, and evaluate its convergent validity and construct validity supported by measurements of gait, balance, and functionality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Hemophilia is a rare inherited bleeding disorder caused by a deficiency of factor (F) VIII or IX. It is a chronic group of diseases that primarily manifests as joint (hemarthrosis) and muscle (hematoma) bleeding, affecting quality of life. Easy bruising in early childhood, especially spontaneous joint and muscle bleeding, and a history of prolonged bleeding after procedures and trauma should raise suspicion of hemophilia. The severity of bleeding symptoms is directly related to the degree of FVIII or FIX deficiency. Although the clinical picture varies depending on the duration and frequency of bleeding, the severity of the disease is classified as severe (<1 IU/dL), moderate (1-5 IU/dL), and mild (5-40 IU/dL). Hemophilia A occurs in 85% of the population (1 in 5,000 male births), while the rate for Hemophilia B is 15% (1 in 30,000 male births). Recurrent and resistant intra-articular bleeding in hemophilia patients leads to the development of hemophilic arthropathy as a result of progressive changes in the joint and bone. Physical performance is significantly affected, especially after recurrent bleeding in the lower extremities. Physical performance is a fundamental physiological indicator of health and functional fitness.Maintaining adequate physical performance is among the most important parameters for preventing social isolation in hemophilia patients, as it improves walking ability and ensures continued independence in daily living activities, participation in school and social activities. Physical performance in children is generally assessed using tests such as the 6-minute walk test, 10-meter walk test, 2-minute walk test, and Timed Up and Go test. However, these assessments may not be practical in routine clinical settings due to space limitations or the need for specialized equipment. The 2-Minute Step Test (2DAT) is a useful alternative that requires minimal equipment and space. This test measures the number of knee lifts (steps) completed during two minutes of steady walking. In addition to simulating walking, the 2DAT also mimics stair climbing, a fundamental activity of daily living. To ensure the test is suitable for both clinical and research settings, its psychometric properties must be evaluated in the relevant population. However, the validity and reliability of the 2DAT have not yet been sufficiently studied in pediatric hemophilia patients. Given the need for accessible and reliable tools to assess physical performance in hemophilia patients, further research is required on the relationship between the 2DAT and this population. In this context, the aim of our study was to evaluate the psychometric properties of the 2-minute walk test in patients with hemophilia, its intra-rater and inter-rater reliability, as well as its convergent validity and construct validity supported by measurements of walking, balance, and functionality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Şahinbey
      • Gaziantep, Şahinbey, Turkey (Türkiye), (505) 090-5846
        • Hasan Kalyoncu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The sample population consists of hemophilia patients aged 6-18 who are receiving outpatient treatment, who voluntarily participate in the study and meet the inclusion criteria. An appropriate sampling method will be used in the sample selection.

Description

Inclusion Criteria:

  • Diagnosed with Hemophilia (A-B) by a physician,
  • Aged 6-18 years,
  • Receiving regular prophylactic treatment,
  • Inhibitor positive or negative,
  • No history of lower extremity joint bleeding within the last month,
  • Individuals who are willing to participate in the study,

Exclusion Criteria:

  • Patients who have undergone surgery on the lower extremities for any reason within the last 6 months,
  • Patients with neurological sequelae following a history of intracranial hemorrhage,
  • Patients experiencing cognitive impairment to the extent that they cannot understand the tests,
  • Patients who indicate they will be unable to participate in follow-up measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Hemophilia Group
The sample population consists of hemophilia patients aged 6-18 years who are receiving outpatient treatment, who voluntarily participate in the study and who meet the inclusion criteria. An appropriate sampling method will be used in the selection of the sample.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
2-Minute Step Test
Time Frame: through of the study, average 4 months
The 2MST is widely used to assess aerobic endurance and physical fitness. In this study, the 2MST protocol developed by Rikli and Jones will be used. Before the test, the midpoint between the anterior superior iliac spine and the top of the patella will be measured for each participant, and the target height for knee elevation will be marked on the wall with adhesive tape for standardization. Upon hearing the verbal cue "Go," participants will begin walking (not running) in place and will lift each knee to reach the target height. The test will be timed with a stopwatch, and the number of steps will be recorded directly by observation by a physical therapist.
through of the study, average 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2-Minute Walk Test (2MWT):
Time Frame: through of the study, average 4 months
The 2MWT is a measure of functional capacity and assesses the total distance an individual can walk within a two-minute period. Participants are asked to walk as safely as possible between two cones placed 15 m apart. The dista
through of the study, average 4 months
Timed Up and Go Test (TUG):
Time Frame: through of the study, average 4 months
The TUG is used to determine functional level and mobility. For the test, the patient sits on a standard chair, stands up from the chair upon the start command, walks as quickly and safely as possible to a marked point 3 meter
through of the study, average 4 months
One-Legged Standing Test:
Time Frame: through of the study, average 4 months
The One-Legged Standing Test will be administered to assess patients' static balance. In the one-legged standing test, while standing with arms hanging down at the sides, each lower extremity will be lifted one at a time, and th
through of the study, average 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tuğba GÖNEN, Asisst. Prof. Dr., Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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