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일상 생활의 청각 장애인의 활동에 대한 전정 기능의 영향 (IVANS)

2026년 11월 5일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

105

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1일 (어린이)

건강한 자원 봉사자를 받아들입니다

해당 없음

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Children coming in consultations in the ENT department

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: CASE_CONTROL
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
OT Hope 0 - 5 ans Therapeutic tool for self determination of pediatric goals in occupational therapy
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Qualitative interviews with parents
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Audrey MAUDOUX, MD, Assistance Publique - Hôpitaux de Paris

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 3월 27일

기본 완료 (추정된)

2028년 4월 1일

연구 완료 (추정된)

2028년 4월 1일

연구 등록 날짜

최초 제출

2025년 3월 27일

QC 기준을 충족하는 최초 제출

2025년 3월 27일

처음 게시됨 (실제)

2025년 4월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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