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临床试验/NCT05674162
NCT05674162已完成不适用

Observer Reactivity During Gait Measurements in a Clinical Setting

Sint Maartenskliniek2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Gait velocity

研究概览

简要总结

Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration of behaviour as a consequence of observation or awareness of measurement. Although researchers are aware of a potential observation effect during measurements, observer reactivity may also influence assessments that are performed as part of clinical care. Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes and most studies examined the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking, and observed walking combined with awareness of measurement, in a within-subjects repeated measures design.

详细描述

Observer reactivity, also known as the 'Hawthorne effect', can roughly be described as the alteration in behaviour as a consequence of observation or awareness of measurement. It is believed that this could influence research outcomes in prospective experimental and observational studies. However, as described in a recent systematic review, the extend of the effect on research outcomes is still debated. The available studies on observer reactivity with various populations and tasks generate contradicting findings and conclusions. Especially within the health sciences, more research is necessary as observer reactivity may confound study results in the direction of better health outcomes.

Previous research on observer reactivity during gait measurements has resulted in contradicting outcomes. For example, some studies showed a higher walking velocity and better gait symmetry under observation, while others showed an opposite effect. This may be caused by the variation in diagnosis group between the studies or small sample sizes. Because of these mixed results and the low number of studies available on this topic, there is yet no consensus on a generalizable effect of observation during gait measurements. Furthermore, most studies examine the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals.

For clinical decision making, it is essential to investigate whether gait measurements are representative for the actual gait pattern of the patient. Therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking by a researcher, and observed walking combined with awareness of measurement by sensors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

The participants are masked to existence of different conditions, not to the measurement of their data.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subacute or chronic stroke (>3 months ago)

排除标准

  • Not able to walk 50 meters without resting.
  • Not able to understand instructions given by the researcher.

结局指标

主要结局

Gait velocity

时间窗: 5 minutes

Mean walking speed (meters/second)

次要结局

  • percent single leg stance symmetry(5 minutes)
  • percent single leg stance(5 minutes)
  • Cadance(5 minutes)
  • Stance time symmetry(5 minutes)
  • Stride length variability(5 minutes)
  • Swing time variability(5 minutes)
  • Swing time symmetry(5 minutes)
  • Stride length(5 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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