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NCT Number: NCT05417399

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

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.

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roessingh Research and Development

Enschede, Overijssel, 7522AH, Netherlands

Location status: Recruiting

Location contact

Jos Spoelstra, Hoofd I&A

CONTACT

[email protected]

003188 087 5757

Martin Oude Alink, Msc

PRINCIPAL_INVESTIGATOR

About this study

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:

  • 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?
  • 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:

  • With awareness of observation + without Dual-task
  • With awareness of observation + with Dual-task
  • Without awareness of observation + without Dual-task
  • Without awareness of observation + with Dual-task

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Minimal knee flexion during the single support phase

    Time frame: Day 1

    Minimal knee flexion during the single support phase

Secondary outcomes

  1. Foot to floor angle at initial contact

    Time frame: Day 1

  2. Knee flexion at initial contact

    Time frame: Day 1

  3. Foot to floor angle at moment of minimal knee flexion in single support phase

    Time frame: Day 1

  4. Variation of knee kinematics in stance phase

    Time frame: Day 1

    Calculated with the Winters-Waveform Coefficient of variation

  5. Variation of ankle kinematics in stance phase

    Time frame: Day 1

    Calculated with the Winters-Waveform Coefficient of variation

  6. Walking speed

    Time frame: Day 1

  7. Cadence

    Time frame: Day 1

  8. Step length

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Oude Alink, Msc

CONTACT

[email protected]

0031534875454

Sponsors and collaborators

Lead sponsor

Roessingh Research and Development

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 14, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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