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Résztvevőt keres itt: OlaszországFázis nélkül

Interactive Mirroring Games wIth sOcial Robot (IOGIOCO) and Robotic System Adapted Into a Clinical Scale (RISCALE)

A legfontosabb adatok

Ki végzi
Fondazione Don Carlo Gnocchi ETS
Hol
Milan (Olaszország)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
40 fő, tervezett
Kezdés
2023. júl. 14.
Tervezett befejezés
2025. máj.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Intervention with social robot NAO
  • Treatment as usual
A regiszteradat frissítve
2025. március 3.

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.

A vizsgálat autizmus spektrum zavarral élő kisgyermekeket keres. A szokásos terápia mellett NAO nevű szociális robottal gyakorolnának.

Életkor
18 hónapos kortól 72 hónapos korig.
Nem
Nemtől függetlenül bárki részt vehet.
A betegség stádiuma
Autizmus spektrum zavar diagnózisa szükséges.

A részvétel fő kizáró okai

  • Ismert genetikai vagy anyagcsere-betegség

A regiszter feltételei, szó szerint

Mind a 2 feltétel megnézéseKevesebb

Ki vehet részt

  • Autism Spectrum Disorder diagnosis

Ki nem vehet részt

  • known genetic or metabolic diseases

Helyszínek itt: Olaszország

  • Santa Maria Nascente, Milano, Italy 20148Milan, OlaszországContact: Anna CavalliniRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

Background: The importance of early intervention in Autism Spectrum Disorders (ASD) has been widely demonstrated, and developmental trajectories in ASD highlight the importance of nonverbal communication, such as intransitive gesture production, as a possible positive prognostic factor for language development. The use of technological tools in the therapy of individuals with ASD has also become increasingly important due to their increased engagement and responsiveness to technological objects, such as robots.

A teljes eredeti leírásKevesebb

Materials and methods: We developed a training protocol using the humanoid robot NAO, called IOGIOCO (Interactive mirroring Games wIth sOCial rObot), based on the use of intransitive gestures embedded in naturalistic dialogues, stimulating a triadic interaction between child, robot and therapist. The training is divided into six levels; the first 2 levels were called "familiarization levels," and the other 4 were "training levels". The technological setup includes different complexity levels, from mirroring tasks to building spontaneous interactions. We previously tested the protocol on 10 preschool children with ASD (aged 2-6 years) in a pilot study founding promising results (Annunziata et al,2024). We therefore developed a Randomized Controlled Trial to test the efficacy of this intervention.

The project is to be divided into three phases.

1. Establishment, adaptation, and subsequent validation of the video recording setting, accompanied by the identification of the quantitative parameters discernible through technological tools (ECSP-I_rob) on a sample of typically developing children aged between 18 and 24 months. 2. Setting, adaptation, and and subsequently validate the video recording setting with the measurement of the quantitative parameters detectable through technological tools (ECSP-I_rob) on a sample of children with Autism Spectrum Disorder under the age of 72 months.

3) Initiate training with NAO on a group of children with ASD aged 24-72 months with pre- and post-treatment ECSP-I administration

Objectives

1. Evaluate the effectiveness of the robot-based intervention on social-communicative skills and in the acquisition of intransitive gestures used for communicative purposes using the ECSP-I and the MacArthur questionnaire as outcome measures. 2. Identify and describe measurable parameters of "social" interaction within the rehabilitation session with NAO and the operator. Furthermore, it is essential to verify their evolution and differences at the beginning and end of treatment and between the different social partners.

We aim to enroll 20 typical children aged 18-24 months to validate the ECSP-I robot.

For the phase 2 and 3 we aim to enroll 20 ASD preschool children with an ASD diagnosis according to DSM-5 criteria (confirmed by ADOS-2). We will test them at T0 (Griffiths-III, ABAS-II, MacArthur-Bates number of gestures) and randomly assign them to two groups, G1 and G2, according to a cross-over design. After T0 assessment, Group 1 will undergo to a 12-weekly-session training with the social robot NAO, while G2 will continue the therapy as usual. We will assess again at T1 (after 12 sessions, through ABAS-II and MacArthur-Bates), subsequently G1 will be included in a follow-up group, while the G2 will undergo to the social robot intervention. We will assess all the participants at T2; we will moreover administrate a satisfaction questionnaire to parents.

A vizsgálat 2 csoportja

  • Group 1A vizsgált kezelés

    The group 1 will be assessed at T0, will undergo to control period of 12 weeks, continuing treatment as usual, at T1 will be re-assessed and will undergo to treatment with robot NAO + treatment as usual for 12 weeks, then will undergo to re-assessment at T2

    Kezelés: Intervention with social robot NAO és Treatment as usual

  • Group 2A vizsgált kezelés

    The group 2 will be assessed at T0, will undergo to treatment with robot NAO + treatment as usual for 12 weeks, at T1 will be re-assessed and then will undergo to follow-up period of 12 weeks, continuing treatment as usual, then will undergo to re-assessment at T2

    Kezelés: Intervention with social robot NAO és Treatment as usual

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.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
A regiszteradat frissítve
2025. március 3.