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Tracking General Movements

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ClinicalTrials.gov Identifier: NCT04241445
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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
Clinical Reasoning Cerebral Palsy General Movement Assessment

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.

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

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)



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241445


Locations
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Austria
MUGraz
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04241445    
Other Study ID Numbers: 30-261 ex 17/18
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases