Influence of Hawthorne Effect and Dual-tasks on Gait in CP
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Gait Disorders, Neurologic, Hawthorne Effect, Dual-tasks. Basic parameters: 4 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ecological Validity of Clinical Gait Analysis in Children With Cerebral Palsy: Influence of the Hawthorne Effect and Dual-tasks. A Pilot Study
Overview
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
Primary outcome measures
- Minimal knee flexion during the single support phase [Time frame: Day 1]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Roessingh Research and Development — Enschede
Identifiers
NCT: NCT05417399 · 2022-13822