Observer Reactivity During Gait Measurements in a Clinical Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observer Reactivity During Gait Measurements in a Clinical Setting

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Unobserved
* Behavioral: Observed
* Radiation: Unobserved & Measured


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subacute or chronic stroke (>3 months ago) Exclusion Criteria: Not able to walk 50 meters without resting. Not able to understand instructions given by the researcher.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single group, repeated measures model.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait measurement<br>Use of four accellerometers/sensors (1 on each foot, one on the lumbar area and one on the sternum) that measure gait parameters during walking. | Behavioral: Unobserved<br>* Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher.<br>Behavioral: Observed<br>* Participants walk a distance of 40 meters wearing the sensors, observed by the researcher.<br>Radiation: Unobserved & Measured<br>* Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher and aware of the gait measurement by the sensors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait velocity | Mean walking speed (meters/second) | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stride length | Mean stride length (meters) | 5 minutes | 
| Cadance | Cadance (steps/minute) | 5 minutes | 
| Stance time symmetry | Symmetry in stance time between paretic and non-paretic leg | 5 minutes | 
| Swing time symmetry | Symmetry in swing time between paretic and non-paretic leg | 5 minutes | 
| percent single leg stance | percent single leg stance of the total gait cycle of the paretic leg | 5 minutes | 
| percent single leg stance symmetry | Symmetry in percent single leg stance between paretic and non-paretic leg | 5 minutes | 
| Stride length variability | Variability in stride length | 5 minutes | 
| Swing time variability | Variability in swing time of the paretic leg | 5 minutes |