Influence of Hawthorne Effect & Dual-tasks on Gait in CP

Status Recruiting

Clinical 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. 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05417399
Study type	Observational
Source	Roessingh Research and Development
Contact	Martin Oude Alink, Msc
Phone	0031534875454
Email	m.oudealink@roessingh.nl
Status	Recruiting
Phase
Start date	September 1, 2022
Completion date	January 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Influence of Hawthorne Effect and Dual-tasks on Gait in CP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms