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

Study acronym: VET-PED
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07793032
Lead Sponsor IRCCS Fondazione Stella Maris
Collaborators: Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento
Conditions
(from sponsor)
Cerebral Palsy (CP), Developmental Coordination Disorder (DCD)
Related terms Cerebral Palsy, Motor Skills Disorders
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov