- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04375059
Effects of Attention Training on Children
Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder
연구 개요
상세 설명
A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.
The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.
Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.
The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater
Exclusion Criteria:
- age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Study group
3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs
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using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
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간섭 없음: Control group
3 months of conventional rehabilitation programs without interactive attention training programs
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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changes of symptoms of attention deficit hyperactivity disorder
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
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score assessed by Swanson, Nolan and Pelham questionnaire
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
changes of sensory integration
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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score assessed by Sensory Profile
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of visual motor integration
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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score assessed by Beery-Buktenica Visual Motor Integration Test
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of intelligence
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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score assessed by Wechsler Intelligence Scale for Children
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of functional performance
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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score assessed by Pediatric Outcome Data Collection Instrument
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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|
changes of health-related quality of life
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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score assessed by Pediatric Quality of Life Inventory
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of family impact
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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Child Health Questionnaire, parent form 28
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of walking speed
기간: time change from baseline to 3 months of treatment, and 3 months after treatment
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walking speed
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of chair climbing speed
기간: time change from baseline to 3 months of treatment, and 3 months after treatment
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stairs climbing speed
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of balance
기간: time change from baseline to 3 months of treatment, and 3 months after treatment
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one leg standing time
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of coordination
기간: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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Berg Balance Scale
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of balance and coordination
기간: time change from baseline to 3 months of treatment, and 3 months after treatment
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timed up and go test
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of physical performance
기간: time change from baseline to 3 months of treatment, and 3 months after treatment
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5 time sit to stand test
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time change from baseline to 3 months of treatment, and 3 months after treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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 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. .