Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2

Cochlear Implantation Clinical Trial

— H2R2  

Official title:

Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832373
• Other study ID #: RC31/20/0250
• Secondary ID: 2020-A01989-30.
• Status: Completed
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: March 29, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implantation

Intervention

Device:
• Interaction with humanoid robot
A humanoid robot will be installed for 30 days in children. It has a touchscreen tablet, allowing manual interaction complementing the voice interaction. The robot speaks, hears, and has facial and voice identification.

Locations

Country	Name	City	State
France	University Hospital Toulouse - Service d'ORL, ORL pédiatrique et Otoneurologie	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of a humanoid robot	assess by the number of weekly hours during which the child uses the robot.	month 1
Secondary	Relationship to technology	Assessment by a set of questionnaires and standardized scales validated by the scientific community	month 1
Secondary	Intention of use	Assessment by a set of questionnaires and standardized scales validated by the scientific community	month 1
Secondary	Relationship with the robot	Assessment by a set of questionnaires and standardized scales validated by the scientific community	month 1
Secondary	User experience	Assessment by a set of questionnaires and standardized scales validated by the scientific community	Month 1
Secondary	participants' expectations	Measurement by sentence completion which consists of giving the beginning of a sentence and letting the user complete the rest of the sentence	Month 1
Secondary	3Emethod	Evaluation of emotions in the form of a drawing with a speech bubble and a thought bubble.	Month 1
Secondary	classification of activities	classification according to various criteria (good functioning, fun, ease of use)	Month 1
Secondary	Feedback	with a Semi-structured interview on the use of the robot	Month 1