Clinical trial NCT04832373: Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2
Official title: Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implantation
Keywords: cochlear implantation
humanoid robot
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2021-04-05
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The quality of the rehabilitation of deafness in children with cochlear implantation is a major prognostic factor for the outcome on speech comprehension and oral expression. This rehabilitation is carried out cooperatively by the hospital cochlear implantation team, and by a speech therapist located near the child's home. The multi-weekly sessions represent a constraint for the child and his parents. Complementary training work at home would make it possible to balance the equity in the distribution of care in the territory, and should promote the progress of the child, who is more inclined to use a tool available at home.

Detailed description: The humanoid robot should allow an ecological approach to this additional rehabilitation. Before developing this approach, it is necessary to study the acceptability of the humanoid robot at home, both by the parents and by the cochlear implanted child. The main objective of this study is to assess the acceptability by the child and his family, of a humanoid robot installed at home for one month.

The secondary objectives are to describe the acceptability of the child and his family that is the relationship to technology, the intention of use, expectations, perceived utility, perception of the robot and facilitating conditions before then after 1 month of using the robot at home,

- describe the child's acceptability with respect to his experience, his fun and the emotions felt when he uses the robot at home

Eligibility criteria: Inclusion Criteria:

* Child aged 8 to 12, user of his cochlear implant with a favorable family environment,
* Child implanted with at least one cochlear implant undergoing speech therapy rehabilitation, and monitored by the pediatric cochlear implant unit (UPIC) of the Toulouse University Hospital
* Child and his family whose mother tongue is French
* Affiliation to a social security scheme

Exclusion Criteria:

* Cognitive or psychological inability or refusal of the participant to give written consent
* Other sensory or motor deficit that may interfere with the use of the robot
* Unstable psychiatric pathology
* Child with both parents benefiting from a legal protection measure

Primary outcomes:
measure: Acceptability of a humanoid robot
timeFrame: month 1
Secondary outcomes:
measure: Relationship to technology
timeFrame: month 1
measure: Intention of use
timeFrame: month 1
measure: Relationship with the robot
timeFrame: month 1
measure: User experience
timeFrame: Month 1
measure: participants' expectations
timeFrame: Month 1
measure: 3Emethod
timeFrame: Month 1
measure: classification of activities
timeFrame: Month 1
measure: Feedback
timeFrame: Month 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse - Service d'ORL, ORL pédiatrique et Otoneurologie
Study officials:
affiliation: University Hospital, Toulouse
name: Olivier DEGUINE, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diehl JJ, Schmitt LM, Villano M, Crowell CR. The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review. Res Autism Spectr Disord. 2012 Jan;6(1):249-262. doi: 10.1016/j.rasd.2011.05.006.
citation: Stiti S, Caroux L, Gaillard P, Paubel PV, Deguine O. Innovative protocol of an exploratory study evaluating the acceptability of a humanoid robot at home of deaf children with cochlear implants. PLoS One. 2023 Jun 16;18(6):e0285927. doi: 10.1371/journal.pone.0285927. eCollection 2023.