Vestibular DisorderKG-REHABNCT04353115
A Serious Game to Rehabilitate Gaze Stability in Children with Vestibular Deficit
An observational study of Vestibular Disorder, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Training with Serious game
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2021to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with vestibular disorde
Who may be able to join
- 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
Who cannot join
- Associated visual sensorineural deficit
- Orthopedic or muscular disorder in the cervical spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vestibular Disorder
- Being tested
- Training with Serious game
- Keywords
- Vestibular Disorder, serious game, vestibular rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Training with Serious Game | Trained group, 5 weeks training with the serious game; patients have a vestibular impairment. Receives: Device: Training with Serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 5
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start29 Sep 2021
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353115
- Sponsor's protocol ID
- 69HCL19_0692
- Acronym
- KG-REHAB
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2020
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37752531
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of a Serious Game to Rehabilitate Gaze Stability in Children with Vestibular Deficit: "Kids Gaze Rehabilitation"
- ClinicalTrials.gov ID
- NCT04353115
- Acronym / sponsor ID
- KG-REHAB / 69HCL19_0692
- Conditions
- Vestibular Disorder
- Keywords
- Vestibular Disorder, serious game, vestibular rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training with Serious Game | – | Device: Training with Serious gameTrained group, 5 weeks training with the serious game; patients have a vestibular impairment. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with vestibular disorde
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Associated visual sensorineural deficit
- Orthopedic or muscular disorder in the cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with Serious gametraining 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. | Device | Training with Serious Game |
Primary outcome
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.
6 secondary outcomes
side effects after the 5 weeks of intervention
Time frame: Week 5
Patient satisfaction
Time frame: week 5
Satisfaction of the patient's parents
Time frame: Week 5
Alouette test
Time frame: Week 5
Posturo-motor control
Time frame: Week 5
Visual acuity
Time frame: Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 37752531Ortega 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Disorder, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of patients able to use the serious game without side effects (time frame: Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.