Cerebral Palsy (CP), Developmental Coordination Disorder (DCD)
Conditions
Keywords
VET, Cerebral Palsy, developmental coordination disorder, manual dexterity
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.
Interventions
DEVICEVirtual 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.
Sponsors
IRCCS Fondazione Stella Maris
Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of Box and Blocks Test (BBT) | At baseline | 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. |
| Score of Tyneside Pegboard Test (TPT) | At baseline | 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. |
| Score of ABILHAND-Kids (only for children with CP) | At baseline | 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. |
| Score of Semmes Weinstein monofilament test | At baseline | 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. |
| Score of Motor Coordination Questionnaire (DCDQ'07) (for children with DCD) | At baseline | 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. |
| Score of Strength and Difficulties Questionnaire (SDQ) (only for children with DCD) | At baseline | 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. |
| Score of Conners 3- Self-Report Scale (only for children with DCD) | At baseline | 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. |
Countries
Italy
Contacts
CONTACTGiuseppina Sgandurra, PhD, MD
CONTACTMarco Controzzi
PRINCIPAL_INVESTIGATORGiuseppina Sgandurra, PhD, MD
IRCCS Fondazione Stella Maris
Outcome results
None listed