Cerebral PalsyNCT05417399
Influence of Hawthorne Effect and Dual-tasks on Gait in CP
An observational study of Cerebral Palsy and Gait Disorders, Neurologic, run by Roessingh Research and Development at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy, Gait Disorders, Neurologic, Hawthorne Effect
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All subjects are recruited from the patient base of Roessingh Center for Rehabilitation. Subjects will be included in the study when a clinical 3D gait analysis is due and the inclusion and exclusion criteria as mentioned are met.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Roessingh Research and Development
Enschede, Overijssel, 7522AH
Jos Spoelstra, Hoofd I&A, 003188 087 5757, fg@rrd.nl
Martin Oude Alink, Msc
About this study
Official title: Ecological Validity of Clinical Gait Analysis in Children With Cerebral Palsy: Influence of the Hawthorne Effect and Dual-tasks. A Pilot Study
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.
Read the 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:
- 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
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal knee flexion during the single support phase
Minimal knee flexion during the single support phase
Measured: Day 1
Secondary outcomes (8)
Foot to floor angle at initial contact
Measured: Day 1
Knee flexion at initial contact
Measured: Day 1
Foot to floor angle at moment of minimal knee flexion in single support phase
Measured: Day 1
Variation of knee kinematics in stance phase
Calculated with the Winters-Waveform Coefficient of variation
Measured: Day 1
Variation of ankle kinematics in stance phase
Calculated with the Winters-Waveform Coefficient of variation
Measured: Day 1
Walking speed
Measured: Day 1
Cadence
Measured: Day 1
Step length
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roessingh Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Rietman, Professor, Study chair, Roessingh Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417399
- Sponsor's protocol ID
- 2022-13822
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Validity of Clinical Gait Analysis in Children With Cerebral Palsy: Influence of the Hawthorne Effect and Dual-tasks. A Pilot Study
- ClinicalTrials.gov ID
- NCT05417399
- Acronym / sponsor ID
- 2022-13822
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Roessingh Research and DevelopmentUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All subjects are recruited from the patient base of Roessingh Center for Rehabilitation. Subjects will be included in the study when a clinical 3D gait analysis is due and the inclusion and exclusion criteria as mentioned are met.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Minimal knee flexion during the single support phase
Time frame: Day 1
Minimal knee flexion during the single support phase
8 secondary outcomes
Foot to floor angle at initial contact
Time frame: Day 1
Knee flexion at initial contact
Time frame: Day 1
Foot to floor angle at moment of minimal knee flexion in single support phase
Time frame: Day 1
Variation of knee kinematics in stance phase
Time frame: Day 1
Variation of ankle kinematics in stance phase
Time frame: Day 1
Walking speed
Time frame: Day 1
Cadence
Time frame: Day 1
Step length
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hans Rietman, Professor study chair
Roessingh Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Gait Disorders, Neurologic, run by Roessingh Research and Development at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Oude Alink, Msc (0031534875454, m.oudealink@roessingh.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal knee flexion during the single support phase (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.