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Observer Reactivity During Gait Measurements in a Clinical Setting

Observer Reactivity During Gait Measurements in a Clinical Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05674162
Enrollment
20
Registered
2023-01-06
Start date
2023-01-01
Completion date
2023-05-01
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

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

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.

Interventions

BEHAVIORALUnobserved

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

BEHAVIORALObserved

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

RADIATIONUnobserved & Measured

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

Sponsors

Sint Maartenskliniek
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

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

Intervention model description

Single group, repeated measures model.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait velocity5 minutesMean walking speed (meters/second)

Secondary

MeasureTime frameDescription
Stride length5 minutesMean stride length (meters)
Cadance5 minutesCadance (steps/minute)
Stance time symmetry5 minutesSymmetry in stance time between paretic and non-paretic leg
Swing time symmetry5 minutesSymmetry in swing time between paretic and non-paretic leg
percent single leg stance5 minutespercent single leg stance of the total gait cycle of the paretic leg
percent single leg stance symmetry5 minutesSymmetry in percent single leg stance between paretic and non-paretic leg
Stride length variability5 minutesVariability in stride length
Swing time variability5 minutesVariability in swing time of the paretic leg

Other

MeasureTime frameDescription
Fugl Meyer Assessment of Lower Extremities2 minutesStages 3 and 4, both ranging from minimum 0 to maximum 4 points, with a higher score meaning a better outcome

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026