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

A legfontosabb adatok

Ki végzi
IRCCS Fondazione Stella Maris
Hol
Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
130 fő, tervezett
Kezdés
2026. szept. 1.
Várható befejezés
2026. nov. 30.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Virtual Eggs Test (VET)
A regiszteradat frissítve
2026. augusztus 28.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for children and young people with cerebral palsy or developmental coordination disorder, and typically developing young people as a control group. It tests the Virtual Egg Test, a tool to measure hand skills.

Életkor
6 to 21 years
Nem
All sexes
A betegség stádiuma
Cerebral palsy group: MACS Level I-III, BFMF Level I-IV, House Functional Classification Level 4-8, and at least one cognitive index score >70 on the WISC-IV, WISC-V, or WAIS-IV. Developmental coordination disorder group: total mABC-2 score below the 15th percentile, and at least one thinking-skills score not lower than 2 standard deviations below the average, tested in the previous 12 months. Control group: Green zone on the mABC-2 Checklist, and enough thinking and language skills to follow instructions.

A részvétel fő kizáró okai

  • Clear problems with sight or eye movement
  • Other illnesses or disabilities that could affect understanding or doing the tests, such as multiple sclerosis, Parkinson's disease, muscle tone disorders or cancer
  • Heart or lung disease, or heart and blood vessel disease
  • Pregnancy or breastfeeding
  • Not enough cooperation; in the control group, also mental health conditions

A regiszter feltételei, szó szerint

Mind a 27 feltétel megnézéseKevesebb

Ki vehet részt

  • 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
  • Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet

Ki nem vehet részt

  • 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
  • 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
  • Presence of pathological cardiopulmonary or cardiovascular conditions
  • Presence of psychiatric comorbidities
  • Participants with evident visual or oculomotor impairments
  • Pregnancy or breastfeeding
  • Insufficient level of cooperation
  • Participants with evident visual or oculomotor impairments
  • Pregnancy or breastfeeding
  • Insufficient level of cooperation

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 6 és 21 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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).

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Arm 1: Typically Developing ParticipantsA vizsgált kezelés

    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.

    Kezelés: Virtual Eggs Test (VET)

  • Arm 2: Participants with Cerebral Palsy or Developmental Coordination DisorderA vizsgált kezelés

    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.

    Kezelés: Virtual Eggs Test (VET)

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Experimental Validation of the Virtual Eggs Test (VET) in Children and Young Adults With Cerebral Palsy and Developmental Coordination Disorder
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
Illeszkedési kérdések
Forrás: NCT07793032: ki vehet részt
A regiszteradat frissítve
2026. augusztus 28.