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聴覚障害者の日常生活の活動に対する前庭機能の影響 (IVANS)

2026年11月5日 更新者:Assistance Publique - Hôpitaux de Paris

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.

調査の概要

詳細な説明

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:

  1. Group 1: Deaf children with confirmed vestibular impairment.
  2. Group 2: Deaf children without vestibular impairment.
  3. Group 3 (Control Group): Hearing children without vestibular deficits. A total of 105 children (35 per group) will be enrolled over a three-year period during their consultations at the ENT departement.

Methods and Data Collection:

• Quantitative Evaluation:

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:

  • ""Yes, we can do this.""

  • ""Yes, we can do this with help.""

  • ""We can't do this very well.""

  • ""No, we can't do this."" Scores will be assigned to each response, and the overall scores will be compared between the three groups to identify differences in competences and daily activity performance.

    • Qualitative Evaluation:

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:

  1. Deaf children with vestibular impairments will have lower scores in daily life activities, especially in motor-related tasks such as walking, compared to the other two groups.
  2. Deaf children without vestibular impairments may show slight differences compared to hearing children due to their hearing loss but will perform better than children with both hearing and vestibular impairments.
  3. The qualitative interviews will reveal specific challenges faced by families of children with vestibular dysfunction and highlight adaptive strategies.

Outcomes:

  • Primary Outcome: Comparison of daily life activity scores between the three groups using the OT Hope 0-5 years tool.
  • Secondary Outcomes: Analysis of qualitative interview data to explore themes related to motor challenges, family adaptation, and participation in daily routines.

Study Duration:

  • Inclusion period: 3 years.
  • Patient participation: Approximately 1 hour (including questionnaire completion and, for some, qualitative interviews).

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.

研究の種類

観察的

入学 (推定)

105

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1日~2年 (子)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Children coming in consultations in the ENT department

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:CASE_CONTROL
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
deaf children with vestibular disorder

Children aged 0 to 2 years old

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.

deaf children without vestibular disorder

Children aged 0 to 2 years old

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.

hearing children without vestibular disorder

Children aged 0 to 2 years old

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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
OT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy
時間枠: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.

15 minutes

二次結果の測定

結果測定
メジャーの説明
時間枠
Qualitative interviews with parents
時間枠: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.

45 minutes

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Audrey MAUDOUX, MD、Assistance Publique - Hôpitaux de Paris

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年3月27日

一次修了 (推定)

2028年4月1日

研究の完了 (推定)

2028年4月1日

試験登録日

最初に提出

2025年3月27日

QC基準を満たした最初の提出物

2025年3月27日

最初の投稿 (実際)

2025年4月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • APHP250135
  • IDRCB: 2025-A00243-46 (レジストリ識別子:ANSM)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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