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

Sponsor
Roessingh Research and Development (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05417399
Collaborator
(none)
15
1
16
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Ecological Validity of Clinical Gait Analysis in Children With Cerebral Palsy: Influence of the Hawthorne Effect and Dual-tasks. A Pilot Study
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Minimal knee flexion during the single support phase [Day 1]

      Minimal knee flexion during the single support phase

    Secondary Outcome Measures

    1. Foot to floor angle at initial contact [Day 1]

    2. Knee flexion at initial contact [Day 1]

    3. Foot to floor angle at moment of minimal knee flexion in single support phase [Day 1]

    4. Variation of knee kinematics in stance phase [Day 1]

      Calculated with the Winters-Waveform Coefficient of variation

    5. Variation of ankle kinematics in stance phase [Day 1]

      Calculated with the Winters-Waveform Coefficient of variation

    6. Walking speed [Day 1]

    7. Cadence [Day 1]

    8. Step length [Day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roessingh Research and Development Enschede Overijssel Netherlands 7522AH

    Sponsors and Collaborators

    • Roessingh Research and Development

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roessingh Research and Development
    ClinicalTrials.gov Identifier:
    NCT05417399
    Other Study ID Numbers:
    • 2022-13822
    First Posted:
    Jun 14, 2022
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 22, 2022