Experimental Validation of the Virtual Eggs Test (VET) in the Pediatric Population

NCT07793032 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-08-28

No results posted yet for this study

Summary

This study aims to investigate the validity of the Virtual Egg Test (VET) for the assessment of manual dexterity in children and adolescents with cerebral palsy and developmental coordination disorder (experimental group), including a typically developing group for the collection and establishment of normative values (control group).

The clinical site where the study procedures for the experimental group will be conducted is the IRCCS Fondazione Stella Maris in Calambrone (Pisa), Italy. Participants of both sexes and of any ethnicity, aged between 6 and 21 years at the time of recruitment, will be selected according to specific inclusion criteria.

The study protocol consists of two assessment sessions scheduled at an interval of at least 3 days and no more than 5 days.

During the first assessment session (T0), standardized and non-standardized assessment procedures will be administered. First, the Virtual Egg Test (VET) will be administered using the Virtual Egg (VE). The VE is a parallelepiped-shaped device equipped with an internal magnetic mechanism that maintains the walls of the object in a predefined, non-collapsed position. When the grip force exceeds the attractive force between the two magnets, the external walls move closer together, causing the "VE to break" reversibly.

The sensorized platform comprises three distinct sensitive areas: the starting position and two target areas for placing the VEs. The areas are separated by a 6-cm-high barrier.

Subsequently, standardized clinical assessment tests will be administered. During the second assessment session (T1), the Virtual Egg Test (VET) will be administered, followed by a feasibility questionnaire specifically developed for this study regarding its use. The questionnaire will be completed by both the participant and the clinical staff.

Conditions

  • Cerebral Palsy (CP)
  • Developmental Coordination Disorder (DCD)

Interventions

DEVICE

Virtual Eggs Test (VET)

The clinical study consists of one enrollment session and two testing sessions, scheduled 3-5 days apart for both the control group and participants with Cerebral Palsy or Developmental Coordination Disorder. During enrollment, eligibility is assessed and informed consent is obtained, and participant profiling data are collected. The first testing session varies by population. Control participants perform the Virtual Eggs Test (VET) with both dominant and non-dominant hands. Participants with Cerebral Palsy undergo the VET, Box and Block Test, Tyneside Pegboard Test, ABILHAND-Kids, and Monofilament Test. Participants with Developmental Coordination Disorder undergo the VET, Box and Block Test, Tyneside Pegboard Test, DCDQ'07, SDQ, Conners 3 Self-Report Scale, and Monofilament Test. The VET is always administered first. The second testing session consists exclusively of the VET with both hands, following the same administration order as the first session.

Sponsors & Collaborators

  • Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento

    collaborator OTHER
  • IRCCS Fondazione Stella Maris

    lead OTHER

Principal Investigators

  • Giuseppina Sgandurra, PhD, MD · IRCCS Fondazione Stella Maris

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793032 on ClinicalTrials.gov