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

NCT07793032 | Not Yet Recruiting

• 1 other identifier: VET-PED
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

VET; Cerebral Palsy; developmental coordination disorder; manual dexterity

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Score of Box and Blocks Test (BBT)

  At baseline

• Score of Tyneside Pegboard Test (TPT)

  At baseline

• Score of ABILHAND-Kids (only for children with CP)

  At baseline

• Score of Semmes Weinstein monofilament test

  At baseline

• Score of Motor Coordination Questionnaire (DCDQ'07) (for children with DCD)

  At baseline

Study Arms (2)

Arm 1: Typically Developing Participants

EXPERIMENTAL

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)

Arm 2: Participants with Cerebral Palsy or Developmental Coordination Disorder

EXPERIMENTAL

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)

Interventions

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.

Arm 1: Typically Developing Participants; Arm 2: Participants with Cerebral Palsy or Developmental Coordination Disorder

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento: collaborator

Study Sites (1)

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56128, Italy

Location

Related Publications (9)

• 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.

  PMID: 3160243 BACKGROUND

• 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.

  PMID: 37624995 BACKGROUND

• 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.

  PMID: 22309074 BACKGROUND

• 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.

  PMID: 12227615 BACKGROUND

• 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.

  PMID: 23597689 BACKGROUND

• 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.

  PMID: 29247458 BACKGROUND

• 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.

  PMID: 15452296 BACKGROUND

• 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.

  PMID: 40030773 BACKGROUND

• 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.

  PMID: 26584497 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Motor Skills Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Giuseppina Sgandurra, PhD, MD

  IRCCS Fondazione Stella Maris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppina Sgandurra, PhD, MD

CONTACT

+39 050886284; giuseppina.sgandurra@fsm.unipi.it

Marco Controzzi

CONTACT

+39 050883460; marco.controzzi@santannapisa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

IT (1)