Deaf ChildrenNCT06390514
The Benefits of Vibrating Floors for Deaf Children
A study testing vibrating floor and No vibrating floor in people with Deaf Children, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
In view of the difficulties observed in the oral language development of deaf children, it is essential to offer them appropriate and effective care as early as possible. One of the modalities frequently used clinically to stimulate this perception of language in the deaf child is to use the tactile sense via… Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Deaf Children
- What is being tested?
- vibrating floor and No vibrating floor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jan 2024to 15 Jan 2025
- Phase
- Interventional
- 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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Deaf children whose project is to develop oral French language skills
- Deaf children with cochlear implants or hearing aids
- Children with previous experience of the vibrating floor
Who cannot join
- intellectual disability
- impairment
Trial locations and contacts
1 site in 1 country.
About this study
In view of the difficulties observed in the oral language development of deaf children, it is essential to offer them appropriate and effective care as early as possible. One of the modalities frequently used clinically to stimulate this perception of language in the deaf child is to use the tactile sense via vibrations. One such tactile tool used by speech therapists is the vibrating floor, which enables the child to feel sounds through the vibrations perceived by his or her body. Although used in many institutions, there is very little scientific evidence to date of the effectiveness of using the vibrating floor with deaf children.
- Conditions
- Deaf Children
- Being tested
- vibrating floor, No vibrating floor
- Keywords
- vibrating floor benefits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrating floorOther
activities with vibrating floor
No vibrating floorOther
activities without vibrating floor
| Study group | Role | What they receive |
|---|---|---|
| with the vibrating floor | Experimental | Not described Receives: Other: vibrating floor; Other: No vibrating floor |
| without the vibrating floor | Active comparator | Not described Receives: Other: vibrating floor; Other: No vibrating floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language assessment
sound detection, discrimination and repetition
Measured: Throughout the entire study, approximately during 24 months
Secondary outcomes (1)
Questionnaire on feelings and well-being
feelings about vibrating floor
Measured: Throughout the entire study, approximately during 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start8 Jan 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deaf ChildrenStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Bragard, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390514
- Sponsor's protocol ID
- PLANCHER
- Status last verified
- May 2025
- First submitted
- 8 Jan 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Vibrating Floors for Deaf Children
- ClinicalTrials.gov ID
- NCT06390514
- Acronym / sponsor ID
- PLANCHER
- Conditions
- Deaf Children
- Keywords
- vibrating floor benefits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 30 Apr 2024 (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.
In view of the difficulties observed in the oral language development of deaf children, it is essential to offer them appropriate and effective care as early as possible. One of the modalities frequently used clinically to stimulate this perception of language in the deaf child is to use the tactile sense via vibrations. One such tactile tool used by speech therapists is the vibrating floor, which enables the child to feel sounds through the vibrations perceived by his or her body. Although used in many institutions, there is very little scientific evidence to date of the effectiveness of using the vibrating floor with deaf children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with the vibrating floor | Experimental | Other: vibrating floor, Other: No vibrating floor |
| without the vibrating floor | Active comparator | Other: vibrating floor, Other: No vibrating floor |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Deaf children whose project is to develop oral French language skills
- Deaf children with cochlear implants or hearing aids
- Children with previous experience of the vibrating floor
Key exclusion criteria (2 listed)
- intellectual disability
- impairment
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 |
|---|---|---|
| vibrating flooractivities with vibrating floor | Other | with the vibrating floor, without the vibrating floor |
| No vibrating flooractivities without vibrating floor | Other | with the vibrating floor, without the vibrating floor |
Primary outcome
Language assessment
Time frame: Throughout the entire study, approximately during 24 months
sound detection, discrimination and repetition
1 secondary outcome
Questionnaire on feelings and well-being
Time frame: Throughout the entire study, approximately during 24 months
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 May 2025.
- 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.
Anne Bragard, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibrating floor and No vibrating floor in people with Deaf Children, run by Université Catholique de Louvain at 1 site in Belgium.
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 3 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 May 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 Belgium. 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?
Language assessment (time frame: Throughout the entire study, approximately during 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.