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.
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
21 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Inclusion Criteria - Cerebral Palsy Group
* Diagnosis of Cerebral Palsy;
* Participants of either sex and of any ethnicity, aged between 6 and 21 years at the time of recruitment;
* MACS Level I-III (for participants with Cerebral Palsy);
* BFMF Level I-IV (for participants with Cerebral Palsy);
* House Functional Classification Level 4-8;
* At least one cognitive index score \>70 on the WISC-IV, WISC-V, or WAIS-IV;
* Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet.
Inclusion Criteria - Developmental Coordination Disorder Group
* Diagnosis of Developmental Coordination Disorder;
* Participants of either sex and of any ethnicity, aged between 6 and 21 years at the time of recruitment;
* Total mABC-2 score below the 15th percentile;
* At least one cognitive functioning index score not lower than 2 standard deviations below the population mean, assessed using standardized tests performed within the previous 12 months, in order to ensure sufficient ability to understand and cooperate with the proposed activities;
* Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet.
Inclusion Criteria - Control Group
* Participants of either sex and of any ethnicity, aged between 6 and 21 years;
* Green zone on the mABC-2 Checklist;
* Participants with cognitive and language abilities adequate to understand the experiment and follow instructions;
* Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet.
Exclusion Criteria:
Exclusion Criteria - Cerebral Palsy and Developmental Coordination Disorder Groups
* Participants with evident visual or oculomotor impairments;
* Concomitant general or localized comorbidities/disabilities (e.g., multiple sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.) that may interfere with the ability to understand and perform the study protocol;
* Presence of pathological cardiopulmonary or cardiovascular conditions;
* Pregnancy or breastfeeding;
* Insufficient level of cooperation.
Exclusion Criteria - Control Group
* Participants with evident visual or oculomotor impairments;
* Concomitant general or localized comorbidities/disabilities (e.g., multiple sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.) that may interfere with the ability to understand and perform the study protocol;
* Presence of pathological cardiopulmonary or cardiovascular conditions;
* Pregnancy or breastfeeding;
* Presence of psychiatric comorbidities;
* Insufficient level of cooperation.
Primary outcome measure(s)
Score of Virtual Eggs Test (VET) — Baseline (VET test) and 3-5 days after baseline (VET retest) The Virtual Eggs Test (VET) is a medical device for assessing fine and gross dexterity by analyzing the participant's ability to carry fragile objects.
The main components of the VET are a set of fragile objects, called Virtual Eggs (VEs), a sensorized platform used to guide task execution, and software developed to support the therapist in data acquisition.
The VET execution protocol includes two phases: a familiarization phase and a testing phase. The goal of the first phase is to make the participant familiar with the movements to be performed. During the testing phase, participants are asked to carry the selected VEs from one point on the platform to another (passing the barrier) without breaking them and as quickly as possible. At the end of the test, the VET provides a fine dexterity index and a gross dexterity index by combining information regarding the speed of transport of the VEs and the accuracy of grip force regulation.
Trial sites (1)
Facility
City
Region
Status
IRCCS Fondazione Stella Maris
Calambrone
Pisa
More IRCCS Fondazione Stella Maris trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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