NCT04832373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 17, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
Last Updated

December 5, 2025

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

March 31, 2021

Last Update Submit

November 27, 2025

Conditions

Keywords

cochlear implantationhumanoid robot

Outcome Measures

Primary Outcomes (1)

  • Acceptability of a humanoid robot

    assess by the number of weekly hours during which the child uses the robot.

    month 1

Secondary Outcomes (8)

  • Relationship to technology

    month 1

  • Intention of use

    month 1

  • Relationship with the robot

    month 1

  • User experience

    Month 1

  • participants' expectations

    Month 1

  • +3 more secondary outcomes

Study Arms (1)

Humanoid Robot

OTHER
Device: Interaction with humanoid robot

Interventions

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.

Humanoid Robot

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse - Service d'ORL, ORL pédiatrique et Otoneurologie

Toulouse, 31059, France

Location

Related Publications (2)

  • 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.

    PMID: 37327230BACKGROUND
  • 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.

    PMID: 22125579BACKGROUND

Study Officials

  • Olivier DEGUINE, PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

September 17, 2021

Primary Completion

March 29, 2023

Study Completion

March 29, 2023

Last Updated

December 5, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations