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Cerebral Palsy (CP)VET-PEDNCT07793032

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

A study testing Virtual Eggs Test (VET) in people with Cerebral Palsy (CP) and Developmental Coordination Disorder (DCD), run by IRCCS Fondazione Stella Maris at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 6 to 21 yearsHealthy volunteers can take part
What is being tested?
Virtual Eggs Test (VET)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteItaly
Study dates
1 Sep 2026to 30 Nov 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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;
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giuseppina Sgandurra, PhD, MD contact

+39 050886284

giuseppina.sgandurra@fsm.unipi.it

Italy1 site
  • IRCCS Fondazione Stella Maris

    Calambrone, Pisa, 56128

    Giuseppina Sgandurra, PhD, MD, 050886284, giuseppina.sgandurra@fsm.unipi.it

Other trials in Italy

About this study

Official title: Experimental Validation of the Virtual Eggs Test (VET) in Children and Young Adults With Cerebral Palsy and Developmental Coordination Disorder

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.

Read more

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.

Being tested
Virtual Eggs Test (VET)
Keywords
VET, Cerebral Palsy, developmental coordination disorder, manual dexterity
Medical subject headings
Cerebral Palsy, Motor Skills Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Eggs Test (VET)Device

    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 groups in NCT07793032
Study groupRoleWhat they receive
Arm 1: Typically Developing ParticipantsExperimentalA 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.
Receives: Device: Virtual Eggs Test (VET)
Arm 2: Participants with Cerebral Palsy or Developmental Coordination DisorderExperimentalA 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.
Receives: Device: Virtual Eggs Test (VET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (VET test) and 3-5 days after baseline (VET retest)

Secondary outcomes (7)
  1. 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.

    Measured: At baseline

  2. 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.

    Measured: At baseline

  3. 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.

    Measured: At baseline

  4. 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.

    Measured: At baseline

  5. 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.

    Measured: At baseline

  6. 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.

    Measured: At baseline

  7. 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.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793032
Sponsor's protocol ID
VET-PED
Acronym
VET-PED
Status last verified
Aug 2026
First submitted
18 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.

    PubMed 3160243
  • Liang KJ, Chen HL, Huang KL, Wang TM, Shieh JY, Wang TN. Assessment for Tactile Perception in Children With Cerebral Palsy. Am J Occup Ther. 2023 Jul 1;77(4):7704205050. doi: 10.5014/ajot.2023.050106.

    PubMed 37624995
  • Auld ML, Ware RS, Boyd RN, Moseley GL, Johnston LM. Reproducibility of tactile assessments for children with unilateral cerebral palsy. Phys Occup Ther Pediatr. 2012 May;32(2):151-66. doi: 10.3109/01942638.2011.652804. Epub 2012 Feb 7.

    PubMed 22309074
  • Krumlinde-Sundholm L, Eliasson AC. Comparing tests of tactile sensibility: aspects relevant to testing children with spastic hemiplegia. Dev Med Child Neurol. 2002 Sep;44(9):604-12. doi: 10.1017/s001216220100264x.

    PubMed 12227615
  • Jongbloed-Pereboom M, Nijhuis-van der Sanden MW, Steenbergen B. Norm scores of the box and block test for children ages 3-10 years. Am J Occup Ther. 2013 May-Jun;67(3):312-8. doi: 10.5014/ajot.2013.006643.

    PubMed 23597689
  • Basu AP, Kirkpatrick EV, Wright B, Pearse JE, Best KE, Eyre JA. The Tyneside Pegboard Test: development, validation, and observations in unilateral cerebral palsy. Dev Med Child Neurol. 2018 Mar;60(3):314-321. doi: 10.1111/dmcn.13645. Epub 2017 Dec 16.

    PubMed 29247458
  • Arnould C, Penta M, Renders A, Thonnard JL. ABILHAND-Kids: a measure of manual ability in children with cerebral palsy. Neurology. 2004 Sep 28;63(6):1045-52. doi: 10.1212/01.wnl.0000138423.77640.37.

    PubMed 15452296
  • Controzzi M, Angelini L, Randi P, Mucci P, Mazzeo A, Ferrari R, Gruppioni E, Cipriani C. Assessing Hand Function in Trans-Radial Amputees Wearing Myoelectric Hands: The Virtual Eggs Test (VET). IEEE Trans Neural Syst Rehabil Eng. 2024 Dec 31;PP. doi: 10.1109/TNSRE.2024.3524791. Online ahead of print.

    PubMed 40030773
  • Clemente F, D'Alonzo M, Controzzi M, Edin BB, Cipriani C. Non-Invasive, Temporally Discrete Feedback of Object Contact and Release Improves Grasp Control of Closed-Loop Myoelectric Transradial Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2016 Dec;24(12):1314-1322. doi: 10.1109/TNSRE.2015.2500586. Epub 2015 Nov 13.

    PubMed 26584497

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