주의력 결핍 과잉 행동 장애 아동의 실행 기능 재활에 대한 가상 현실. (VREALFUN-ADHD)
어린이 실행 기능 재활의 가상 현실(VREALFUN)
Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.
The major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.
Researchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Merja Nikula, M.Psych.
- 전화번호: +3588315 5218
- 이메일: merja.nikula@pohde.fi
연구 연락처 백업
- 이름: Johanna Uusimaa, MD, PhD
- 이메일: johanna.uusimaa@pohde.fi
연구 장소
-
-
-
Oulu, 핀란드, 90029
- 모병
- Oulu University Hospital
-
연락하다:
- Johanna Uusimaa, MD, PhD
- 이메일: johanna.uusimaa@pohde.fi
-
연락하다:
- Merja Nikula, M.Psych.
- 이메일: merja.nikula@pohde.fi
-
수석 연구원:
- Merja Nikula, M.Psych.
-
부수사관:
- Johanna Uusimaa, MD, PhD
-
부수사관:
- Mirjami Mäntymaa, MD, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of ADHD (ICD-10 F90.0) and
- Methylphenidate medication and
- Age 8-12 years and
- Finnish as a native language
Exclusion Criteria:
- Sensitivity to flashing light,
- Epilepsy (ICD-10 G40),
- Mental retardation (ICD-10 F70-F79),
- Pervasive developmental disorders (ICD-10 F84),
- Inflammatory diseases of the central nervous system (ICD-10 G00-G09),
- Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),
- Traumatic brain injury ((ICD-10 S06),
- Brain tumour, and
- Multiple pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 부모 지도+가상 현실 게임
|
Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma) .
다른 이름들:
Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home. |
|
실험적: 부모 지도
|
Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma) .
다른 이름들:
|
|
실험적: 가상 현실 게임
|
Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home. |
|
간섭 없음: Control Group
This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual). |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Epeli (Executive Performance in Everyday LIving) task
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
A virtual reality task for attention, executive function, and prospective memory. Change in total score, task efficacy, navigation efficacy, controller motion, and total action. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
ADHD-rating scale IV (ADHD-RS) (parent report)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
The ADHD-RS (parent report) is an assessment of a child's ADHD symptoms with 18 items based on the child's behaviour over the past 6 months. 4-point Likert scale. The total score ranges 0-54, scores in inattention subscale and hyperactivity/impulsivity subscale range 0-27. Change in the total score, inattention subscale score, and hyperactivity/impulsivity subscale score on a parent-rated ADHD-RS. A lower score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
Epeli Questionnaire (parent report)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on parent-rated Epeli- questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
Epeli Questionnaire (child report)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on child-rated Epeli- questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the parent. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on parent-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the teacher. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on teacher-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
Concentration questionnaire (in Finnish: Keskittymiskysely)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
An assessment of attention and executive function difficulties in school-aged children with 55 items. 3-point Likert Scale, Total score range 0-110. Change in Total score, Distractibility score (range 0-8), sum of Impulsivity and Motor hyperactivity subscales scores (range 0-32), sum of Directing, Sustaining and Shifting Attention subscales scores (range 0-30), and sum of Initiative, Planning, Execution and Evaluation of Action subscales scores (range 0-40) on teacher-rated Concentration questionnaire. In case the data in the Distractibility subscale, Impulsivity and Motor hyperactivity subscales, Attention subscales and Executive subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on Concentration questionnaire Total score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score implies a worse outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on parent-rated questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on child-rated questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
N-back test
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
A test for a working memory. Change in 2-back and 1-back hitrate and reaction time. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
|
The Conners Continuous Performance Test 3rd Edition (Conners CPT3)
기간: Baseline, 4-6 weeks, 6 months and 12 months.
|
A computerized attention task validated in individuals aged 8 years and older. Change in scores on Conners Continuous Performance Test (CPT-3). |
Baseline, 4-6 weeks, 6 months and 12 months.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 의자: Johanna Uusimaa, MD, PhD, Oulu University Hospital
- 수석 연구원: Merja Nikula, M.Psych., Oulu University Hospital
- 연구 책임자: Mirjami Mäntymaa, MD, PhD, Oulu University Hospital
- 연구 책임자: Juha Salmitaival, PhD, University of Oulu, Finland
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 206/2021
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
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. .