Observer Reactivity During Gait Measurements in a Clinical Setting

Stroke Clinical Trial

Official title:

Observer Reactivity During Gait Measurements in a Clinical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674162
• Other study ID #: 1042_TZO_Observer Reactivity
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 1, 2023

Study information

• Verified date: December 2022
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Unobserved
Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher.
• Observed
Participants walk a distance of 40 meters wearing the sensors, observed by the researcher.

Radiation:
• Unobserved & Measured
Participants walk a distance of 40 meters wearing the sensors, unobserved by the researcher and aware of the gait measurement by the sensors.

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Ubbergen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fugl Meyer Assessment of Lower Extremities	Stages 3 and 4, both ranging from minimum 0 to maximum 4 points, with a higher score meaning a better outcome	2 minutes
Primary	Gait velocity	Mean walking speed (meters/second)	5 minutes
Secondary	Stride length	Mean stride length (meters)	5 minutes
Secondary	Cadance	Cadance (steps/minute)	5 minutes
Secondary	Stance time symmetry	Symmetry in stance time between paretic and non-paretic leg	5 minutes
Secondary	Swing time symmetry	Symmetry in swing time between paretic and non-paretic leg	5 minutes
Secondary	percent single leg stance	percent single leg stance of the total gait cycle of the paretic leg	5 minutes
Secondary	percent single leg stance symmetry	Symmetry in percent single leg stance between paretic and non-paretic leg	5 minutes
Secondary	Stride length variability	Variability in stride length	5 minutes
Secondary	Swing time variability	Variability in swing time of the paretic leg	5 minutes