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

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.

Study Overview

• Status: Completed
• Conditions: Cochlear Implantation
• Intervention / Treatment: Device: Interaction with humanoid robot

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier DEGUINE, PU-PH; Phone Number: +33 05 61 77 77 02; Email: deguine.o@chu-toulouse.fr
• Study Contact Backup: Name: Soumia Taoui-Krattar; Phone Number: +33 05 61 77 22 53; Email: taoui.s@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse - Service d'ORL, ORL pédiatrique et Otoneurologie
    • Sub-Investigator: Marie Noelle Calmels, MD
    • Contact: Olivier Deguine, PH; Email: deguine.o@chu-toulouse.fr
    • Principal Investigator: Olivier Deguine, PU-PH
    • Sub-Investigator: Mathieu MARX, PU- PH
    • Sub-Investigator: Blandine Baladi, PH
    • Sub-Investigator: Yohan Gallois, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Humanoid Robot	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of a humanoid robot	assess by the number of weekly hours during which the child uses the robot.	month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship to technology	Assessment by a set of questionnaires and standardized scales validated by the scientific community	month 1
Intention of use	Assessment by a set of questionnaires and standardized scales validated by the scientific community	month 1
Relationship with the robot	Assessment by a set of questionnaires and standardized scales validated by the scientific community	month 1
User experience	Assessment by a set of questionnaires and standardized scales validated by the scientific community	Month 1
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
3Emethod	Evaluation of emotions in the form of a drawing with a speech bubble and a thought bubble.	Month 1
classification of activities	classification according to various criteria (good functioning, fun, ease of use)	Month 1
Feedback	with a Semi-structured interview on the use of the robot	Month 1

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Centre National de la Recherche Scientifique, France
• Investigators: Principal Investigator: Olivier DEGUINE, PH, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cochlear implantation; humanoid robot
• Other Study ID Numbers: RC31/20/0250; 2020-A01989-30. (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No