Observer Reactivity During Gait Measurements in a Clinical Setting

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Unobserved; Behavioral: Observed; Radiation: Unobserved & Measured

• Registration Number: NCT05674162
• Lead Sponsor: Sint Maartenskliniek

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.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study Start: 2023-01-01
• Study First Posted: 2023-01-06
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gait measurement	Unobserved	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.
Gait measurement	Unobserved & Measured	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.
Gait measurement	Observed	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.

Primary Outcome Measures

Name	Time	Method
Gait velocity	5 minutes	Mean walking speed (meters/second)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sint Maartenskliniek; 🇳🇱 Ubbergen, Gelderland, Netherlands