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

Vestibular Disorder Clinical Trial

— KG-REHAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04353115
• Other study ID #: 69HCL19_0692
• Status: Recruiting
• Start date: September 29, 2021
• Est. completion date: September 29, 2025

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Hung THAI-VAN, PR
• Phone: (0)4 72 11 05 03
• Email: hung.thai-van[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 29, 2025
• Est. primary completion date: September 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Diseases
• Vestibular Disorder

Intervention

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.

Locations

Country	Name	City	State
France	Pr THAI VAN	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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