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Clinical Trials/NCT05417399
NCT05417399
Recruiting
Not Applicable

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

Roessingh Research and Development1 site in 1 country15 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Roessingh Research and Development
Enrollment
15
Locations
1
Primary Endpoint
Minimal knee flexion during the single support phase
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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. 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

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
January 1, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Roessingh Research and Development
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Minimal knee flexion during the single support phase

Time Frame: Day 1

Minimal knee flexion during the single support phase

Secondary Outcomes

  • Foot to floor angle at initial contact(Day 1)
  • Variation of ankle kinematics in stance phase(Day 1)
  • Foot to floor angle at moment of minimal knee flexion in single support phase(Day 1)
  • Walking speed(Day 1)
  • Cadence(Day 1)
  • Variation of knee kinematics in stance phase(Day 1)
  • Knee flexion at initial contact(Day 1)
  • Step length(Day 1)

Study Sites (1)

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