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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Gait Disorders, Neurologic; Kinematics; Hawthorne Effect; Dual-tasks

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

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Martin Oude Alink, Msc; Phone Number: 0031534875454; Email: m.oudealink@roessingh.nl

Study Locations

• Netherlands
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7522AH
      • Recruiting
      • Roessingh Research and Development
      • Contact: Jos Spoelstra, Hoofd I&A; Phone Number: 003188 087 5757; Email: fg@rrd.nl
      • Principal Investigator: Martin Oude Alink, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal knee flexion during the single support phase	Minimal knee flexion during the single support phase	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot to floor angle at initial contact		Day 1
Knee flexion at initial contact		Day 1
Foot to floor angle at moment of minimal knee flexion in single support phase		Day 1
Variation of knee kinematics in stance phase	Calculated with the Winters-Waveform Coefficient of variation	Day 1
Variation of ankle kinematics in stance phase	Calculated with the Winters-Waveform Coefficient of variation	Day 1
Walking speed		Day 1
Cadence		Day 1
Step length		Day 1

Collaborators and Investigators

• Sponsor: Roessingh Research and Development
• Investigators: Study Chair: Hans Rietman, Professor, Roessingh Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 2022-13822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No