Tracking General Movements

NCT04241445 | Unknown

• 1 other identifier: 30-261 ex 17/18
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Clinical Reasoning; Cerebral Palsy; General Movement Assessment

Outcome Measures

Primary Outcomes (3)

• Spotlight on the very early motor repertoire: writhing general movements (WMs); GMA experts only

  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"

  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

  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

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

MUGraz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: April 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)