Tracking General Movements

Sponsor
Medical University of Graz (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04241445
Collaborator
(none)
140
1
48
2.9

Study Details

Study Description

Brief Summary

Background: General movements (GMs) are endogenously generated movements of the entire body observable from the 9th week postmenstrual age to at least 20 weeks postterm age. The assessment of GMs, the GMA, is a method to differentiate between spontaneous normal vs. abnormal motor patterns based on visual Gestalt perception, and has proven to be a reliable tool to evaluate the integrity of the nervous system in early infancy. Trained GMA observers achieve an excellent inter-observer agreement, but this accuracy is known to decline when GMA is applied infrequently. Although specific changes in the quality of GMs are highly predictive for atypical neurodevelopmental trajectories, one pattern of GMs, the poor-repertoire, is still of low predictive power.

Objectives: Tracking GMA observers' intrinsic and unconsciously applied analytic strategies may unravel hitherto unknown characteristics of GMs and Gestalt perception in clinical reasoning. We specifically aim to: detect parameters during the writhing movements period which differentiate normalising and deteriorating developmental trajectories (Aim 1); evaluate different strategies/modalities of expert guidance for clinical reasoning and develop novel didactical approaches for remote GMA training (remote visual and verbal guidance; Aim 2); create a database to provide expert-guided tutorials for remote clinical training, observer re-calibration, and self-evaluation for certified observers (Aim 3).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Approach / methods: Based on our expertise in GMA and eye tracking, and a successful proof of principle (pilot experiment), we will conduct a series of experiments: GMA experts' eye movement patterns during clinical reasoning will be assessed to better understand the diagnostic category of poor-repertoire GMs (Experiment 1); benefits and potential difficulties of different modes of "seeing through the eyes of an expert"-approaches for GMA-training will be explored (Experiment 2); we shall evaluate enhancement of clinical reasoning as a result of intensive remote GMA training (Experiment 3).

    Level of originality / innovation: "Tracking general movements" will (1) contribute to better understand poor-repertoire GMs adding to the clinical necessity to closely follow infants in need for continuous or close-meshed clinical surveillance; (2) define the benefits of different modes/modalities of expert guidance for GMA, which will form the basis for innovative remote clinical GMA training; and (3) create a globally accessible database for remote clinical GMA refreshment-training and re-calibration.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Tracking General Movements: An Observing-the-Observer Approach to Enhance Clinical Reasoning
    Anticipated Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Mar 31, 2023
    Anticipated Study Completion Date :
    Mar 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    novice observers

    who have practiced GMA sporadically (def.: < = 2 GMA/week for < = 2 years), have limited experience, and do not use GMA in clinical settings

    GMA experts

    GMA tutors and individuals who have applied GMA regularly (def.: > 2 GMA/week for > 2 years)

    Outcome Measures

    Primary Outcome Measures

    1. Spotlight on the very early motor repertoire: writhing general movements (WMs); GMA experts only [1st - 16th month]

      Detect parameters during the WMs period which differentiate normalising and deteriorating GM traits by experts

    2. Expert-guided clinical reasoning - "seeing through the eyes of an expert" [21st - 32rd month]

      Develop and provide expert-guided video recordings to complement GMA trainings with three modes of visual expert guidance (i: verbal; ii: visual; iii: verbal+visual) to enhance clinical reasoning in novice observers

    3. Implementation of a database and intensive remote GMA training [17th - 48th month]

      Create the prototype of a password-protected database for clinical GMA training. The database will cover three distinct aspects of GMA training: (i) expert-guided remote training, (ii) re-calibration, and (iii) self-evaluation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Observers have to provide written informed consent to the study protocol, data analysis and data storage guidelines, as well as the publication of study results.

    Observers have to complete the experimental data acquisition. Apart from their lack of GMA training, naïve observers have to be of the same gender, of comparable age and educational level as GMA-trained observers.

    Novice observers and GMA experts have to be certified for GMA. Observers must have normal or corrected-to-normal vision (only individuals wearing soft contact lenses can be included in the eye tracking experiments).

    Exclusion Criteria:

    Observers did not adhere to the study protocol, data analysis, data storage guidelines, or the publication of study results.

    Observers did not complete the experimental data acquisition. Observers have uncorrected visual impairments or visual impairments corrected with glasses/hard contact lenses.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MUGraz Graz Styria Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT04241445
    Other Study ID Numbers:
    • 30-261 ex 17/18
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    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 Jan 27, 2020