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Influence of Hawthorne Effect and Dual-tasks on Gait in CP

Ecological Validity of Clinical Gait Analysis in Children With Cerebral Palsy: Influence of the Hawthorne Effect and Dual-tasks. A Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05417399
Enrollment
15
Registered
2022-06-14
Start date
2022-09-01
Completion date
2028-12-01
Last updated
2026-07-13

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

Conditions

Cerebral Palsy, Dual-tasks, Gait Disorders, Neurologic, Hawthorne Effect, Kinematics

Brief summary

It is the clinical experience of the authors that some children with cerebral palsy who walk in crouch gait show sufficient knee extension during the clinical gait analysis, but walk in considerable knee flexion when they leave the gait laboratory. Possible differences between walking in a gait lab and walking in daily life may be caused by the effect of observational awareness in the lab (also known as the Hawthorne effect), and the lack of dual-tasks (DT) during the analysis (which are common during daily life walking). Since so far there is no technique to reliably measure gait kinematics in children with CP outside of the laboratory, the researchers aim to objectify the influence of both the Hawthorne effect and dual-tasks by introducing different conditions during a standard clinical 3D gait analysis.

Detailed description

Study design: Observational study Study population: Patients with cerebral palsy, bilateral spastic, knee flexion gait pattern, GMFCS classification I-III, age 4-16 years. Objective: To determine the effect of observational awareness (the Hawthorne effect) and dual-tasks on spatiotemporal and kinematic variables during a clinical 3D gait analysis. Primary research question: Does reduced observational awareness and/or introduction of a dual-task influence knee flexion in stance phase in children with spastic diplegie cerebral palsy and knee flexion gait? Secondary research questions: 1. Does reduced observational awareness and/or introduction of a dual-task increase toe walking in children with spastic diplegie cerebral palsy and knee flexion gait? 2. In children with spastic diplegic cerebral palsy and knee flexion gait, do spatiotemporal gait parameters change when observational awareness is reduced and/or a dual-task is introduced? Conditions in which gait data will be gathered: 1. With awareness of observation + without Dual-task 2. With awareness of observation + with Dual-task 3. Without awareness of observation + without Dual-task 4. Without awareness of observation + with Dual-task

Interventions

None listed

Sponsors

Roessingh Research and Development
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* Cerebral palsy, bilateral spastic, GMFCS classification I-III * Age \<16 years * Use of bilateral AFO's (rigid or ground reaction AFO's) to improve knee extension in stance

Exclusion criteria

* Behavioural issues or poor instructability which might affect participation in the protocol * Significant visual disorders * Other diagnoses influencing gait * Not willing to sign informed consent before inclusion

Design outcomes

Primary

MeasureTime frameDescription
Minimal knee flexion during the single support phaseDay 1Minimal knee flexion during the single support phase

Secondary

MeasureTime frameDescription
Foot to floor angle at initial contactDay 1
Knee flexion at initial contactDay 1
Foot to floor angle at moment of minimal knee flexion in single support phaseDay 1
Variation of knee kinematics in stance phaseDay 1Calculated with the Winters-Waveform Coefficient of variation
Variation of ankle kinematics in stance phaseDay 1Calculated with the Winters-Waveform Coefficient of variation
Walking speedDay 1
CadenceDay 1
Step lengthDay 1

Countries

Netherlands

Contacts

CONTACTMartin Oude Alink, Msc
m.oudealink@roessingh.nl0031534875454
STUDY_CHAIRHans Rietman, Professor

Roessingh Research and Development

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026