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临床试验/NCT03855813
NCT03855813已完成不适用

Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.

Vastra Gotaland Region3 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
129
试验地点
3
主要终点
30 seconds chair stand test, comparison self-test vs clinical test.

研究概览

简要总结

Background: It is estimated that 14% of the Swedish population have knee osteoarthritis. Common osteoarthritis symptoms are pain, stiffness and impaired physical function. To evaluate muscle strength in the lower extremities could indicate if there is a risk for a patient with osteoarthritis to worsen their disease. Increased muscle strength could improve physical function and pain for this patient group. A reliable self-test to evaluate physical function could help patients with diagnosed or suspected knee osteoarthritis to seek healthcare in time. The 30 seconds chair stand test (30 CST) is part of a test battery which is recommended to use for patients with osteoarthritis, both in research and in a clinical setting. It is a valid and a reliable measurement for patients with osteoarthritis. However, reliability studies of the 30 CST as a self-test is lacking.

Objective: To determine whether 30 CST is a reliable self-test to evaluate physical function among patients with knee osteoarthritis, we want to explore how much it differs in the test results when the patient is performing the test by herself and also compare it with when it is conducted in a clinical setting.

Methods: 147 participants with knee osteoarthritis will be recruited from three rehabilitations centers in primary care. The participant will perform the self-test twice at home, and the self-test will be compared with when the test is guided by a physical therapist at a rehabilitation center. The reliability results will be presented with an intraclass correlation coefficient and standard error measurement.

Estimated results: It is expected that the results from this study will clarify if 30 CST can be used as a self-test for persons with suspected or diagnosed/confirmed knee osteoarthritis. If this performance test show enough reliability to be used as a self-test, it could be used as an indicator if the patient should seek healthcare or not due to impaired function. To seek healthcare in an earlier phase usually require less efforts and often leads to shorter healthcare process. These improvements of the healthcare process could be of value to manage the expected future increase of osteoarthritis consultations to primary care.

详细描述

The project leader will be visiting recruiting units to inform and educate about the study protocol and data collection procedure.

Patient recruitment

Patients with knee osteoarthritis will be recruited from three rehabilitations centers in region Västra Götaland, Sweden. When eligible participants have been identified according to inclusion criteria, the participants will get written information about the study, including informed consent, manual to the 30 CST self-test, and questionnaires.

Data Collection

30 CST: The 30 CST will be performed on an approximately 45 cm high chair without armrest (if possible). The participant will be asked to perform as many stands as possible during 30 seconds. Start position is sitting on the chair, and the arms should be crossed over the chest during the whole test. The stands must be to upright standing position (i.e. fully extended hips and knees), and back to sitting position. The patients pain intensity will be measured with numeric rating scale before and during the test.

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

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with knee osteoarthritis. The patients should have most problem with their knees, but are allowed to have osteoarthritis in other lower extremity joints.
  • Independent in walking, with or without walking aids.
  • Understand test instructions verbally and in writing.

排除标准

  • Neurological disorders that affects the patients balance or gait.
  • Severe somatic or mental illness that affect the physical functional performance or the ability to understand test instructions verbally or in text.
  • Knee or hip replacement the past six months.
  • Other knee surgery the past six months that could affect the physical functional performance.

结局指标

主要结局

30 seconds chair stand test, comparison self-test vs clinical test.

时间窗: Two occasions within approximately seven days to establish inter rater reliability

30 seconds chair stand test will be used as a self-test and as a clinical test led by a physical therapist. Number of stands will be counted.

30 seconds chair stand test as self-test.

时间窗: Two occasions within approximately three days to establish intra rater reliability

30 seconds chair stand test will be used as a self-test. Number of stands will be counted.

次要结局

  • Pain intensity during 30 seconds chair stand test(Three occasions within approximately 14 days, between the first and last testing with 30 seconds chair stand test.)
  • Osteoarthritis pain(Baseline)
  • Difficulties with activities due to knee pain(Baseline)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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