Measurement Properties (Reliability and Validity) of a Set of Assessments Evaluating Physical Function in People with Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Timed up and Go (TUG)
研究概览
简要总结
The aim of this project is to determine the measurement properties (namely reliability and validity) of a set of clinical assessments, measuring different aspects of physical function.
详细描述
The medical treatment of hemophilia has advanced greatly in recent years. There are now medications that reduce the physical symptoms of hemophilia. Nevertheless, those affected by hemophilia suffer from restricted mobility, reduced strength, reduced balance and pain as a result of the repeated bleeding. In order to make well-founded decisions regarding possible supportive therapeutic or medical measures, it is important to be able to estimate the extent of such limitations and whether these will change or remain stable.
The study is needed to validate the measurement properties of measurement instruments used to measure the effects of physical training interventions in participants with hemophilia. Clinical questions can only be solved if measuring instruments with sufficient measuring properties are used. These measurement properties must be evaluated in a relevant population. Otherwise, health professionals cannot assess whether measures or treatment are not effective or whether measured changes are not large enough to detect an actual change. Therefore, research is required to ensure that adequately studied measurement instruments are available for clinical assessment of those affected by adult participants with hemophilia.
Some of the tests (such as the Unipedal Stance Test or Four Square Step Test) have already been studied in children with hemophilia or in participants with other diseases. Since hemophilia is a disease with specific effects, the measuring instruments must also be researched in this participant group. There is still a research gap that the investigators would like to close with this study. For the study, the investigators selected tests that are already being used on adult participants with hemophilia and have had good experiences in practice. The tests are safe and can be carried out with little strain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Hemophilia Types A or B
- •Adult people ≥ 18 years
- •Patients on prophylactic factor or non-factor replacement treatment, or on demand factor replacement treatment.
- •Able to walk for 20 meters independently, with or without walking aid
- •Signed informed consent to participate in the study
排除标准
- •Severe health conditions like severe cardiovascular, pulmonary, neurological or musculoskeletal diseases.
- •Unable to perform the assessments due to disability or language problems.
研究组 & 干预措施
Single Test-Re Test Arm
This study, including two time points, is performed to determine validity and reliability of performance based assessments using a one-arm sample.
A test retest design is used to determine reliability and a cross-sectional design to determine validity.
For each participant, the measures will be performed on two time points with a minimal recovery break of 2 days in one single centre in the Canton of Zurich (University Hospital Zurich).
干预措施: Measurement Properties (Reliability and Validity) of a Set of Assessments evaluating Physical Function in adult Participants with Hemophilia (Other)
结局指标
主要结局
Timed up and Go (TUG)
时间窗: Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
The TUG is a performance-based outcome measure that assesses lower extremity function, mobility, and fall risk. In this test, the participant starts in a seated position, with his back against a standard height chair, without armrest. The participant gets up and walks in a comfortable pace for 10 feet (three meters), turns around and returns to a seated position in the chair. The time to perform the task is measured in seconds. Shorter time indicates better mobility.
30-Second Stair Stand Test
时间窗: Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
The 30-Second Chair Stand Test measures the muscle function of the lower extremity by counting how many times a patient rises from a seated position to a full stand at his/her own pace
1 kg Arm Lift Test
时间窗: Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
The 1 kg arm lift test measures the muscle function of the upper extremity. It counts how many time a patient can lift a 1 kilogram weight above their head within 30 seconds at his/her own pace
Short Physical Performance Battery (SPPB)
时间窗: Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
SPPB comprises three components: Standing balance (open stand, half tandem stand and tandem stand), timed four meter usual paced walk, and timed test of five sit-to-stands from a standard chair. Each component is scored from 0 to 4, with maximum of 12and timed test of five sit-to-stands from a standard chair.
Four Square Step Test (FSST)
时间窗: Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
The FSST is a performance-based outcome measure assessing dynamic balance. The test set up consists of four walking sticks of the same width in a cross formation. Participants step into each square in a clockwise sequence and back anticlockwise as fast as possible while not being allowed to hit the sticks.
Unipedal Stance Test (UST)
时间窗: Baseline (Day 1) followed after a minimum break of 48 hours by Follow up (Day 2).
The UST is a balance assessment that is widely used in clinical settings to monitor neurological and musculoskeletal conditions. Abnormal values may indicate conditions that may impair balance and will quantify balance status for those who are at increased risks for fall. The test is performed barefoot, hands crossed over the chest and once with eyes open and once with eyes closed. Patient stands on one leg unassisted; time begins when opposite foot leaves the ground. Time stops immediately when arms are uncrossed, the raised foot is used to maintain balance or touches the ground, weight-baring foot is moved, 45 second have elapsed or when eyes were opened on eyes closed trial. Each condition (eyes open or eyes closed) is performed three times, alternatively.
次要结局
- Short Form 36(Baseline (Day 1))
- Hemophilia Joint Health Score Version 2.1(Baseline (Day 1))
- Hemophilia Activities List(Baseline (Day 1))