NCT06390514

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

January 8, 2024

Last Update Submit

May 7, 2025

Conditions

Deaf Children

Keywords

vibrating floor benefits

Outcome Measures

Primary Outcomes (1)

  • Language assessment

    sound detection, discrimination and repetition

    Throughout the entire study, approximately during 24 months

Secondary Outcomes (1)

  • Questionnaire on feelings and well-being

    Throughout the entire study, approximately during 24 months

Study Arms (2)

with the vibrating floor

EXPERIMENTAL
Other: vibrating floorOther: No vibrating floor

without the vibrating floor

ACTIVE COMPARATOR
Other: vibrating floorOther: No vibrating floor

Interventions

vibrating floorOTHER

activities with vibrating floor

with the vibrating floorwithout the vibrating floor
No vibrating floorOTHER

activities without vibrating floor

with the vibrating floorwithout the vibrating floor

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • intellectual disability
  • impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bragard Anne

Louvain-la-Neuve, Brabant, 1348, Belgium

Location

Study Officials

  • Anne Bragard, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

April 30, 2024

Study Start

January 8, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)