NCT04353115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

March 2, 2020

Last Update Submit

March 10, 2025

Conditions

Vestibular Disorder

Keywords

Vestibular Disorderserious gamevestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • side effects after the 5 weeks of intervention

    Week 5

  • Patient satisfaction

    week 5

  • Satisfaction of the patient's parents

    Week 5

  • Alouette test

    Week 5

  • Posturo-motor control

    Week 5

  • +1 more secondary outcomes

Study Arms (1)

Training with Serious Game

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

Device: Training with Serious game

Interventions

Training with Serious gameDEVICE

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.

Training with Serious Game

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with vestibular disorde

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pr THAI VAN

Bron, Bron, 69500, France

Location

Related Publications (1)

  • Ortega Solis J, Reynard P, Spruyt K, Becaud C, Ionescu E, Thai-Van H. Developing a serious game for gaze stability rehabilitation in children with vestibular hypofunction. J Neuroeng Rehabil. 2023 Sep 26;20(1):128. doi: 10.1186/s12984-023-01249-x.

    PMID: 37752531DERIVED

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

April 20, 2020

Study Start

September 29, 2021

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)