HemophiliaNCT07425327
Validity and Reliability of the Two-minute Step Test in Hemophilia
An observational study of Hemophilia and Step, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia, Step, Reliability and Validity
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 25 Aug 2026
- 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 6 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Şahinbey, (505) 090-5846
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemophilia, Step, Reliability and Validity, Hemophilia A and B
- Keywords
- Hemophilia A, Hemophilia B, Two minute step test
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
2-Minute Step Test
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.
Measured: through of the study, average 4 months
Secondary outcomes (3)
2-Minute Walk Test (2MWT):
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
Measured: through of the study, average 4 months
Timed Up and Go Test (TUG):
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
Measured: through of the study, average 4 months
One-Legged Standing Test:
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
Measured: through of the study, average 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start25 Feb 2026
- Primary completion25 Apr 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba GÖNEN, Hasan Kalyoncu University
- Investigators
- Tuğba GÖNEN, Asisst. Prof. Dr., Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425327
- Sponsor's protocol ID
- 2025/157
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nogueira MA, Almeida TDN, Andrade GS, Ribeiro AS, Rego AS, Dias RDS, Ferreira PR, Penha LRLN, Pires FO, Dibai-Filho AV, Bassi-Dibai D. Reliability and Accuracy of 2-Minute Step Test in Active and Sedentary Lean Adults. J Manipulative Physiol Ther. 2021 Feb;44(2):120-127. doi: 10.1016/j.jmpt.2020.07.013. Epub 2021 Jan 9.
PubMed 33431278Cederberg KLJ, Sikes EM, Bartolucci AA, Motl RW. Walking endurance in multiple sclerosis: Meta-analysis of six-minute walk test performance. Gait Posture. 2019 Sep;73:147-153. doi: 10.1016/j.gaitpost.2019.07.125. Epub 2019 Jul 10.
PubMed 31326830Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
PubMed 10960937Eriksen L, Curtis T, Gronbaek M, Helge JW, Tolstrup JS. The association between physical activity, cardiorespiratory fitness and self-rated health. Prev Med. 2013 Dec;57(6):900-2. doi: 10.1016/j.ypmed.2013.09.024. Epub 2013 Oct 5.
PubMed 24099878Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available.
PubMed 32744769
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Validity and Reliability of the Two-minute Step Test in Patients With Hemophilia
- ClinicalTrials.gov ID
- NCT07425327
- Acronym / sponsor ID
- 2025/157
- Conditions
- Hemophilia, Step, Reliability and Validity, Hemophilia A and B
- Keywords
- Hemophilia A, Hemophilia B, Two minute step test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 20 Feb 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
2-Minute Walk Test (2MWT):
Time frame: through of the study, average 4 months
Timed Up and Go Test (TUG):
Time frame: through of the study, average 4 months
One-Legged Standing Test:
Time frame: through of the study, average 4 months
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 23 Sep 2026.
- Results publication: PubMed 33431278Nogueira MA, Almeida TDN, Andrade GS, Ribeiro AS, Rego AS, Dias RDS, Ferreira PR, Penha LRLN, Pires FO, Dibai-Filho AV, Bassi-Dibai D. Reliability and Accuracy of 2-Minute Step Test in Active and Sedentary Lean Adults. J Manipulative Physiol Ther. 2021 Feb;44(2):120-127. doi: 10.1016/j.jmpt.2020.07.013. Epub 2021 Jan 9.
- Results publication: PubMed 31326830Cederberg KLJ, Sikes EM, Bartolucci AA, Motl RW. Walking endurance in multiple sclerosis: Meta-analysis of six-minute walk test performance. Gait Posture. 2019 Sep;73:147-153. doi: 10.1016/j.gaitpost.2019.07.125. Epub 2019 Jul 10.
- Results publication: PubMed 10960937Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
- Results publication: PubMed 24099878Eriksen L, Curtis T, Gronbaek M, Helge JW, Tolstrup JS. The association between physical activity, cardiorespiratory fitness and self-rated health. Prev Med. 2013 Dec;57(6):900-2. doi: 10.1016/j.ypmed.2013.09.024. Epub 2013 Oct 5.
- Results publication: PubMed 32744769Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available.
- Individual participant dataSharing planned: No
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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.
Tuğba GÖNEN, Asisst. Prof. Dr. principal investigator
Hasan Kalyoncu 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 Hemophilia and Step, run by Hasan Kalyoncu University 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 6 inclusion and 4 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 23 Sep 2026. 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?
2-Minute Step Test (time frame: through of the study, average 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425327, which also lists 5 linked publications.
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 23 Sep 2026.