- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06390514
The Benefits of Vibrating Floors for Deaf Children
April 25, 2024 updated by: Université Catholique de Louvain
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anne Bragard, PhD
- Phone Number: 003210474393
- Email: anne.bragard@uclouvain.be
Study Locations
-
-
Brabant
-
Louvain-la-Neuve, Brabant, Belgium, 1348
- Recruiting
- Bragard Anne
-
Contact:
- Anne Bragard
- Email: anne.bragard@uclouvain.be
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- intellectual disability
- impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: with the vibrating floor
|
activities with vibrating floor
|
Active Comparator: without the vibrating floor
|
activities without vibrating floor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Language assessment
Time Frame: Throughout the entire study, approximately during 24 months
|
sound detection, discrimination and repetition
|
Throughout the entire study, approximately during 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire on feelings and well-being
Time Frame: Throughout the entire study, approximately during 24 months
|
feelings about vibrating floor
|
Throughout the entire study, approximately during 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne Bragard, PhD, Université Catholique de Louvain
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2024
Primary Completion (Estimated)
January 15, 2025
Study Completion (Estimated)
January 15, 2026
Study Registration Dates
First Submitted
January 8, 2024
First Submitted That Met QC Criteria
April 25, 2024
First Posted (Actual)
April 30, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PLANCHER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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