Robert Debré Hospital
Paris, 75019, France
Location contact
Amandine TISSIER
CONTACT
Audrey MAUDOUX, MD
CONTACT
NCT Number: NCT06909266
This non-interventional study aims to assess the impact of vestibular impairments on the daily life activities of deaf children aged 0 to 2 years old. Three groups of participants will be included: deaf children with vestibular impairment, deaf children without vestibular impairment, and hearing children without vestibular dysfunction (control group).
Children's daily activities will be evaluated through the OT Hope 0-5 years tool, a parent-administered questionnaire designed to measure competencies in different areas: personal care, play, and social interactions. This study also includes qualitative interviews with parents to further explore how vestibular impairments affect children's daily routines.
It is hypothesized that:
* Deaf children with vestibular impairments will show lower scores in daily life activities compared to the other two groups. * Deaf children without vestibular impairments will demonstrate scores closer to those of hearing children but may show some differences due to their hearing status.
The research is conducted at the Robert Debré Hospital, in Paris, and aims to enroll 105 children over a three-year period. The data collected will provide insights into the specific needs of children with vestibular impairments and lay the groundwork for targeted early interventions.
Trial opening soon.
Get Notified1 day–2 year
All sexes
Observational
Paris, 75019, France
Amandine TISSIER
CONTACT
Audrey MAUDOUX, MD
CONTACT
This non-interventional, observational, case-control study aims to evaluate the impact of vestibular impairments on the daily life activities and functional development of deaf children aged 0 to 2 years. The study focuses on understanding how vestibular dysfunction, a condition affecting balance, posture, and motor skills, influences children's ability to perform essential daily tasks such as walking, sitting, and interacting with their environment from a occupational therapist point of view.
Study Design:
Participants will be divided into three distinct groups:
Methods and Data Collection:
Children's daily life activities will be assessed using the OT Hope 0-5 years questionnaire, which is completed by parents with assistance from an occupational therapist. This tool measures children's competences across key domains, including personal care, play, and social interactions. Responses are categorized into four levels:
It will be proposed to some parents to participate in qualitative interviews designed to explore their experiences, challenges, and strategies related to their child's daily routines and motor development. These interviews will provide insights on the impact of vestibular impairments on family life and the child's autonomy.
Hypotheses:
The study is based on the following hypotheses:
Outcomes:
Study Duration:
Ethical and Regulatory Considerations:
The study complies with ethical standards for human research and data confidentiality regulations. Parents' non-opposition will be documented, and all collected data will be anonymized and securely stored.
By exploring both quantitative and qualitative dimensions, this study aims to provide a comprehensive understanding of how vestibular impairments affect the functional development and autonomy of young children, with the ultimate goal of guiding early interventions and improving clinical practices.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group 1: Deaf children with confirmed vestibular impairment. Group 2: Deaf children without vestibular impairment. Group 3: Hearing children without vestibular impairment (control group).
Exclusion criteria
Presence of neuromotor or orthopedic disorders. Presence of pervasive developmental disorders that could interfere with daily activity assessments."
OT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy
qualitative interviews to understand how vestibular impairments affect their child's daily life activities, challenges encountered, and strategies used to support participation.
Time frame: 15 minutes
Assessment of daily life activities in children aged 0-2 years using the OT Hope 0-5 tool. Parents rate their child's performance in personal care, play, and social interactions. Scores associated will be compared across three groups to evaluate the impact of vestibular impairments.
Time frame: 45 minutes
Exploration of parents' perspectives through qualitative interviews to understand how vestibular impairments affect their child's daily life activities, challenges encountered, and strategies used to support participation.
Contact information is provided by the study sponsor or research team.
Amandine TISSIER, MD
CONTACT
Audrey MAUDOUX, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: IVANS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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