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

Recruiting

• Conditions: Vestibular Disorder
• Interventions: Device: Training with Serious game

• Registration Number: NCT04353115
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-20
• Study Start: 2021-09-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-09-29
• Study Completion: 2025-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Associated visual sensorineural deficit
• Orthopedic or muscular disorder in the cervical spine

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training with Serious Game	Training with Serious game	Trained group, 5 weeks training with the serious game; patients have a vestibular impairment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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.
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
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.
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.

Trial Locations

Locations (1)

Pr THAI VAN; 🇫🇷 Bron, France