An interventional study of Virtual Eggs Test (VET) in Cerebral Palsy (CP) and Developmental Coordination Disorder (DCD), sponsored by IRCCS Fondazione Stella Maris. Not yet recruiting at 1 site in Italy. Open to participants aged 6 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by IRCCS Fondazione Stella Maris · Not applicable, Interventional, and Other
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 130 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →IRCCS Fondazione Stella Maris is the lead sponsor of 46 studies on the registry; 27 are open to participants now.
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Inclusion Criteria:
Inclusion Criteria - Cerebral Palsy Group
Inclusion Criteria - Developmental Coordination Disorder Group
Inclusion Criteria - Control Group
Exclusion Criteria:
Exclusion Criteria - Cerebral Palsy and Developmental Coordination Disorder Groups
Exclusion Criteria - Control Group
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A total of 80 participants aged 6-21 years with typical development will be recruited. Participants will be stratified by age and sex, with at least five females and five males recruited for each of the following age groups: 6-7, 8-9, 10-11, 12-13, 14-15, 16-17, 18-19, and 20-21 years. All participants will perform the Virtual Egg Test (VET) during two testing sessions, scheduled 3 or 5 days apart.
Device: Virtual Eggs Test (VET)
A total of 50 participants aged 6-21 years with Cerebral Palsy or Developmental Coordination Disorder will be recruited. Participants will be distributed across the following age groups, irrespective of sex: 6-7, 8-9, 10-11, 12-13, 14-15, 16-17, 18-19, and 20-21 years. Participants will perform the Virtual Egg Test (VET) during two testing sessions, scheduled 3 or 5 days apart.
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.
Score of Virtual Eggs Test (VET)
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.
Time frame: Baseline (VET test) and 3-5 days after baseline (VET retest)
Score of Box and Blocks Test (BBT)
The Box and Block Test (BBT) measures unilateral manual dexterity. The BBT consists of a wooden box divided into two compartments by a barrier and 150 blocks. The test involves asking the patient to move, one by one, the maximum number of blocks from one compartment of the box to the other, within 60 seconds. Higher scores on the test indicate better gross manual dexterity. This standardized test has also been validated for pediatric use and is used widely in clinical practice among assessment tests for upper limb performance in children with neurodevelopmental disorders and disabilities, such as CP.
Time frame: At baseline
Score of Tyneside Pegboard Test (TPT)
The Tyneside Pegboard Test (TPT) is a test for measuring fine manual dexterity in children with unilateral CP. During the test, participants are asked to insert nine pegs into a pegboard as quickly as possible. Based on the tests available in the literature for assessing manual dexterity, the TPT can quantitatively measure, in terms of time, manual dexterity in children with hand motor impairment, such as children with unilateral CP. A faster execution time indicates greater fine motor skills.
Time frame: At baseline
Score of ABILHAND-Kids (only for children with CP)
Is a brief questionnaire that measures 21 key bimanual daily activities. The score is assigned by a parent based on the difficulty the child has in performing the requested activity on a daily basis, using a 3-point scale (impossible, difficult, easy). The response scores are entered into a Rasch model to obtain a continuous score representing the child's level of manual ability. A higher score indicates greater manual skill and autonomy. It has been validated in children with Cerebral Palsy aged 6 to 15 years, showing good validity (R=0.94) and good reproducibility over time (R=0.91). Only participants of CP group will be tested with ABILHAND-Kids.
Time frame: At baseline
Score of Semmes Weinstein monofilament test
Sensory perception is evaluated with the Semmes-Weinstein monofilaments which are designed to exert specific amounts of force when applied to the skin. They come in various sizes, each representing a different level of force or pressure. During the examination, the therapist will apply the monofilaments to the distal phalanx index of each hand and the participant will be asked to indicate whether they can feel the monofilament, with vision occluded. The score is based on the three correct trials of the last monofilament applied. A lower monofilament stimulus intensity indicates better sensory perception. This measure was introduced to assess tactile perception of children with CP, as it is often associated with the motor impairment typical of children with this diagnostic profile.
Time frame: At baseline
Score of Motor Coordination Questionnaire (DCDQ'07) (for children with DCD)
The Motor Coordination Questionnaire (DCDQ) is a measurement tool for parents, developed to help identify Motor Coordination Disorder (DCD) in children, aged 5 to 15 years. Parents are asked to compare their child's motor performance with that of their peers, using a 5-point Likert scale. The questionnaire provides a standardized method for measuring a child's motor coordination in daily activities. The internal consistency of the DCDQ is high and the results from discriminant function analyses were appropriately strong for a screening tool. Only participants of DCD group will be tested with DCDQ.
Time frame: At baseline
Score of Strength and Difficulties Questionnaire (SDQ) (only for children with DCD)
This is a rather concise instrument that provides a wealth of information about a child's behavior. It contains 25 items that refer to positive or negative attributes of the child's behavior. The items are divided into 5 subscales: hyperactivity, conduct problems, emotional difficulties, prosocial behavior, and peer relationships. The same questionnaire can be completed by both teachers and parents, to assess children between the ages of 4 and 16. The evaluator uses a 3-point Likert scale to indicate how descriptive a given attribute is of the child's behavior. On the four scales describing negative behaviors, a higher score corresponds to more severe difficulties. On the Prosocial Behavior scale, a higher score indicates more positive behaviors Only participants of DCD group will be tested with SDQ.
Time frame: At baseline
Score of Conners 3- Self-Report Scale (only for children with DCD)
An assessment tool used to identify and analyze behaviors and symptoms associated with behavior and attention disorders in children. Being a self-completed questionnaire, it provides important information about how the child behaves in all situations, not just at home or at school. The questionnaire consists of both content and syndrome subscales, with raw scores transformed to age- and gender-normed T-scores (mean = 50, SD = 10). Higher scores are indicative of greater problems, with scores between 60 and 69 considered "elevated" and scores above 70 "very elevated." Only participants of DCD group will be tested with Conners 3- Self-Report Scale.
Time frame: At baseline
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IRCCS Fondazione Stella Maris