KG-REHAB: A Serious Game to Rehabilitate Gaze Stability in Children With Vestibular Deficit

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04353115
Collaborator
(none)
30
1
24
1.3

Study Details

Study Description

Brief Summary

Since the early 2000s, vestibular rehabilitation has been proposed as a therapeutic tool to improve the balancing function and the various motor skills in children, in particular in children with hearing loss suffering from concomitant vestibular deficit. It has been demonstrated in adults with vestibular deficit that the fact of adding to the classic exercises on the control of balance per se and habituation, specific exercises of adaptation and substitution of the vestibulo-ocular reflex brought therapeutic benefit. These exercises, which are started in the presence of the physiotherapist and then continued by the patient himself at his home, aim to improve the stabilization of the gaze during head movements. In pediatrics, however, performing them is more difficult than conventional exercises, since their immediate interest is not well understood by the child, who may be reluctant to perform them. The present project aims to enrich the therapeutic offer by a pediatric rehabilitation method of eye stabilization sufficiently playful to win adherence to treatment, including in the absence of the physiotherapist when the child is at home.

Condition or Disease Intervention/Treatment Phase
  • Device: Training with Serious game

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Usability of a Serious Game to Rehabilitate Gaze Stability in Children With Vestibular Deficit: "Kids Gaze Rehabilitation"
Actual Study Start Date :
Sep 29, 2021
Anticipated Primary Completion Date :
Sep 29, 2023
Anticipated Study Completion Date :
Sep 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Training with Serious Game

Trained group, 5 weeks training with the serious game; patients have a vestibular impairment.

Device: Training with Serious game
training the gaze stability with a serious game, 20 minutes a day, 2 days a week for 5 weeks in the presence of a doctor or physiotherapist, at the hospital to avoid addiction at home.

Outcome Measures

Primary Outcome Measures

  1. Numbers of patients able to use the serious game without side effects [Week 5]

    the purpose is to defined the proportion of patients able to use the serious game without side effects for 20 minutes a day, 2 days a week for 5 weeks in the presence of a doctor or physiotherapist at the hospital in addition to the usual rehabilitation.

Secondary Outcome Measures

  1. side effects after the 5 weeks of intervention [Week 5]

    The side effects collected after the 5 weeks of intervention or at the end of the intervention if it is interrupted before the end are: Intolerance to the screen sickness technique, motion sickness type (dizziness, headache, nausea, vomiting, eyestrain, visual disturbances, inability to stand after a session) By means of an adapted questionnaire SSQ (Child Simulator Sickness Questionnaire), adapted and translated into French. Values from 0 to 70 : 70 means that childs feel sick

  2. Patient satisfaction [week 5]

    Description: will be defined using a Likert scale of faces after each session (5 questions, from 1 to 5 points). 1 being not at all satisfied with the game and 5 being completely satisfied with the game after each session. Suggestions for modifying the game will also be collected

  3. Satisfaction of the patient's parents [Week 5]

    Satisfaction of the patient's parents will be defined using a Likert scale of 5 questions out of 5 points, 1 being not at all satisfied with the game and 5 being completely satisfied with the game after each session. Game modification suggestions will also collected

  4. Alouette test [Week 5]

    The Alouette test which assesses the fluency in reading questionnaires. The interest of the serious game at the end of the 5 weeks will be evaluated using the comparison between the initial and 5 week evaluation.

  5. Posturo-motor control [Week 5]

    The Posturo-motor control with the movement evaluation battery in children M-ABC 2. The interest of the serious game at the end of the 5 weeks will be evaluated using the comparison between the initial and 5 week evaluation.

  6. Visual acuity [Week 5]

    The interest of the serious game at the end of the 5 weeks will be evaluated using the comparison between the initial and 5 week evaluation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosed with a vestibular disorder by the batteries of tests used in clinical routine.

  • Supported by the multidisciplinary team of the Audiology and Otoneurological Exploration Department at the HFME

  • Patient or parents able to understand the ins and outs of the study

  • No opposition from children and parents

Exclusion Criteria:
  • Associated visual sensorineural deficit

  • Orthopedic or muscular disorder in the cervical spine

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pr THAI VAN Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04353115
Other Study ID Numbers:
  • 69HCL19_0692
First Posted:
Apr 20, 2020
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
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 Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022