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Completed

NCT Number: NCT04353115

A Serious Game to Rehabilitate Gaze Stability in Children with Vestibular Deficit

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.

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Key information

Conditions

Vestibular Disorder Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases Vestibular Diseases

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pr THAI VAN

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training with Serious game

Device

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.

Primary outcomes

  1. Numbers of patients able to use the serious game without side effects

    Time frame: 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 outcomes

  1. side effects after the 5 weeks of intervention

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Usability of a Serious Game to Rehabilitate Gaze Stability in Children with Vestibular Deficit: "Kids Gaze Rehabilitation"

Acronym: KG-REHAB

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2020
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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