- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06909266
일상 생활의 청각 장애인의 활동에 대한 전정 기능의 영향 (IVANS)
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
상태
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:
- Group 1: Deaf children with confirmed vestibular impairment.
- Group 2: Deaf children without vestibular impairment.
- 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.""
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""Yes, we can do this with help.""
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""We can't do this very well.""
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""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:
- 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.
- 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.
- 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
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Audrey MAUDOUX, MD
- 전화번호: +33140032449
- 이메일: audrey.maudoux@aphp.fr
연구 연락처 백업
- 이름: Amandine TISSIER, MD
- 전화번호: +33140032449
- 이메일: amandine_tissier@hotmail.fr
연구 장소
-
-
-
Paris, 프랑스, 75019
- 모병
- Robert Debré Hospital
-
연락하다:
- Audrey MAUDOUX, MD
- 전화번호: +33140032449
- 이메일: audrey.maudoux@aphp.fr
-
연락하다:
- Amandine TISSIER
- 전화번호: 0140032449
- 이메일: amandine_tissier@hotmail.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
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
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
수사관
- 수석 연구원: Audrey MAUDOUX, MD, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- APHP250135
- IDRCB: 2025-A00243-46 (레지스트리 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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