Influence of Hawthorne Effect and Dual-tasks on Gait in CP
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-16
SponsorRoessingh Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Minimal knee flexion during the single support phase
Minimal knee flexion during the single support phase
Time frame
Day 1Secondary outcomes
1
Foot to floor angle at initial contact
Time frame
Day 12
Knee flexion at initial contact
Time frame
Day 13
Foot to floor angle at moment of minimal knee flexion in single support phase
Time frame
Day 14
Variation of knee kinematics in stance phase
Calculated with the Winters-Waveform Coefficient of variation
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov