Cerebral Palsy Clinical Trial
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Roessingh Research and Development | Enschede | Overijssel |
Lead Sponsor | Collaborator |
---|---|
Roessingh Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minimal knee flexion during the single support phase | Minimal knee flexion during the single support phase | Day 1 | |
Secondary | Foot to floor angle at initial contact | Day 1 | ||
Secondary | Knee flexion at initial contact | Day 1 | ||
Secondary | Foot to floor angle at moment of minimal knee flexion in single support phase | Day 1 | ||
Secondary | Variation of knee kinematics in stance phase | Calculated with the Winters-Waveform Coefficient of variation | Day 1 | |
Secondary | Variation of ankle kinematics in stance phase | Calculated with the Winters-Waveform Coefficient of variation | Day 1 | |
Secondary | Walking speed | Day 1 | ||
Secondary | Cadence | Day 1 | ||
Secondary | Step length | Day 1 |
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