Tracking General Movements

January 22, 2020 updated by: Medical University of Graz

Tracking General Movements: An Observing-the-Observer Approach to Enhance Clinical Reasoning

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).

Study Overview

Status

Enrolling by invitation

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 Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Styria
      • Graz, Styria, Austria, 8036
        • MUGRAZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For the proposed experiments, observers will be divided into three groups. One group will consist of (a) naïve observers, that is, individuals who are not familiar with GMs, have not received any GMA training and are not medically educated. The two other groups will consist of (b) GMA-trained and certified observers: (b1) novice observers who have practiced GMA sporadically (def.: <= 2 GMA/week for <= 2 years) and have only little experience; and (b2) GMA experts, i.e. GMA tutors and individuals who have applied GMA regularly (def.: > 2 GMA/week for > 2 years).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spotlight on the very early motor repertoire: writhing general movements (WMs); GMA experts only
Time Frame: 1st - 16th month
Detect parameters during the WMs period which differentiate normalising and deteriorating GM traits by experts
1st - 16th month
Expert-guided clinical reasoning - "seeing through the eyes of an expert"
Time Frame: 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
21st - 32rd month
Implementation of a database and intensive remote GMA training
Time Frame: 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
17th - 48th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 30-261 ex 17/18

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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