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OpenTrials
Completed

NCT Number: NCT05674162

Observer Reactivity During Gait Measurements in a Clinical Setting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unobserved

Behavioral

Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher.

Observed

Behavioral

Participants walk a distance of 40 meters wearing the sensors, observed by the researcher.

Unobserved & Measured

Radiation

Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher and aware of the gait measurement by the sensors.

Primary outcomes

  1. Gait velocity

    Time frame: 5 minutes

    Mean walking speed (meters/second)

Secondary outcomes

  1. Stride length

    Time frame: 5 minutes

    Mean stride length (meters)

  2. Cadance

    Time frame: 5 minutes

    Cadance (steps/minute)

  3. Stance time symmetry

    Time frame: 5 minutes

    Symmetry in stance time between paretic and non-paretic leg

  4. Swing time symmetry

    Time frame: 5 minutes

    Symmetry in swing time between paretic and non-paretic leg

  5. percent single leg stance

    Time frame: 5 minutes

    percent single leg stance of the total gait cycle of the paretic leg

  6. percent single leg stance symmetry

    Time frame: 5 minutes

    Symmetry in percent single leg stance between paretic and non-paretic leg

  7. Stride length variability

    Time frame: 5 minutes

    Variability in stride length

  8. Swing time variability

    Time frame: 5 minutes

    Variability in swing time of the paretic leg

Other outcomes

  1. Fugl Meyer Assessment of Lower Extremities

    Time frame: 2 minutes

    Stages 3 and 4, both ranging from minimum 0 to maximum 4 points, with a higher score meaning a better outcome

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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