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血友病患者两分钟踏步测试的有效性与可靠性

2026年9月17日 更新者:Tuğba GÖNEN、Hasan Kalyoncu University

研究血友病患者两分钟踏步测试的有效性与可靠性

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

31

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Şahinbey
      • Gaziantep、Şahinbey、土耳其(türkiye)、(505) 090-5846
        • Hasan Kalyoncu University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 18年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

男性

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
2-Minute Step Test
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
2-Minute Walk Test (2MWT):
大体时间: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):
大体时间: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:
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tuğba GÖNEN, Asisst. Prof. Dr.、Hasan Kalyoncu University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月25日

初级完成 (实际的)

2026年4月25日

研究完成 (实际的)

2026年8月25日

研究注册日期

首次提交

2026年2月13日

首先提交符合 QC 标准的

2026年2月13日

首次发布 (实际的)

2026年2月20日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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