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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vestibular Disorder
• Intervention / Treatment: Device: Training with Serious game

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Hung THAI-VAN, PR; Phone Number: +33 (0)4 72 11 05 03; Email: hung.thai-van@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Pr THAI VAN
    • Contact: THAI VAN Hung, Pr; Phone Number: +33 4 27 85 54 90; Email: hung.thai-van@chu-lyon.fr
    • Contact: REYNARD Pierre, Dr; Phone Number: +33 4 72 11 05 03; Email: pierre.reynard@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with vestibular disorde

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of patients able to use the serious game without side effects	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.	Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects after the 5 weeks of intervention	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	Week 5
Patient satisfaction	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	week 5
Satisfaction of the patient's parents	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	Week 5
Alouette test	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.	Week 5
Posturo-motor control	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.	Week 5
Visual acuity	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.	Week 5

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Estimated): September 29, 2025
• Study Completion (Estimated): September 29, 2025

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: serious game; vestibular rehabilitation; Vestibular Disorder
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: 69HCL19_0692

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