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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04832373
Collaborator
Centre National de la Recherche Scientifique, France (Other)
10
Enrollment
1
Location
1
Arm
21
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Interaction with humanoid robot
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability of a humanoid robot [month 1]

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

Secondary Outcome Measures

  1. Relationship to technology [month 1]

    Assessment by a set of questionnaires and standardized scales validated by the scientific community

  2. Intention of use [month 1]

    Assessment by a set of questionnaires and standardized scales validated by the scientific community

  3. Relationship with the robot [month 1]

    Assessment by a set of questionnaires and standardized scales validated by the scientific community

  4. User experience [Month 1]

    Assessment by a set of questionnaires and standardized scales validated by the scientific community

  5. participants' expectations [Month 1]

    Measurement by sentence completion which consists of giving the beginning of a sentence and letting the user complete the rest of the sentence

  6. 3Emethod [Month 1]

    Evaluation of emotions in the form of a drawing with a speech bubble and a thought bubble.

  7. classification of activities [Month 1]

    classification according to various criteria (good functioning, fun, ease of use)

  8. Feedback [Month 1]

    with a Semi-structured interview on the use of the robot

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Toulouse - Service d'ORL, ORL pédiatrique et Otoneurologie Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse
  • Centre National de la Recherche Scientifique, France

Investigators

  • Principal Investigator: Olivier DEGUINE, PH, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04832373
Other Study ID Numbers:
  • RC31/20/0250
  • 2020-A01989-30.
First Posted:
Apr 5, 2021
Last Update Posted:
Apr 5, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
cochlear implantation
humanoid robot

Study Results

No Results Posted as of Apr 5, 2021