Observer Reactivity During Gait Measurements in a Clinical Setting

NCT05674162 | Completed

• 1 other identifier: 1042_TZO_Observer Reactivity
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Gait velocity

  Mean walking speed (meters/second)

  5 minutes

Secondary Outcomes (8)

• Stride length

  5 minutes

• Cadance

  5 minutes

• Stance time symmetry

  5 minutes

• Swing time symmetry

  5 minutes

• percent single leg stance

  5 minutes

Other Outcomes (1)

• Fugl Meyer Assessment of Lower Extremities

  2 minutes

Study Arms (1)

Gait measurement

EXPERIMENTAL

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; Behavioral: Observed; Radiation: Unobserved & Measured

Interventions

Unobserved BEHAVIORAL

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

Gait measurement

Observed BEHAVIORAL

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

Gait measurement

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.

Gait measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subacute or chronic stroke (\>3 months ago)

You may not qualify if:

• Not able to walk 50 meters without resting.
• Not able to understand instructions given by the researcher.

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

Location

MeSH Terms

Conditions

Stroke

Interventions

No-Observed-Adverse-Effect Level

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Toxicity Tests; Investigative Techniques; Toxicological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Noël LW Keijsers, PhD

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants are masked to existence of different conditions, not to the measurement of their data.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, repeated measures model.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: January 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)