- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03632629
Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder
Treatment Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder and Developmental Delay
연구 개요
상세 설명
A total of 30 children with attention deficit hyperactivity disorder and developmental delays who are receiving traditional rehabilitation programs will be enrolled.
The participants will be randomized into two groups, including study group (traditional rehabilitation program with additional cognitive training: 2 times per week, 15 min per session, a total of 24 sessions) and control group (traditional rehabilitation program without additional cognitive training).
Memory related functions, quality of life, and physical function evaluations will be performed at baseline, 3 months and 6 months later, respectively.
Evaluator will be blinded to the group's classification during the whole course of study.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Taipei, 대만, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- children diagnosed with attention deficit hyperactivity disorder with developmental delay receiving regular rehabilitation programs intelligence quotient 70 or greater
Exclusion Criteria:
- age less than 4 years or elder than 8 years children diagnosed with attention deficit hyperactivity disorder receiving regular rehabilitation programs intelligence quotient less than 70
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: study group
3 months of individualized interactive cognitive training, 2 times per week, 15 min per session, a total of 24 sessions, in addition to traditional rehabilitation programs.
|
Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay
|
간섭 없음: control group
3 months of traditional rehabilitation programs, without individualized interactive cognitive training.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
change of attention
기간: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Swanson, Nolan and Pelham questionnaire
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
change of visual motor integration
기간: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Beery-Buktenica Visual Motor Integration Test
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
change of sensory integration
기간: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Sensory Profile questionnaire
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
change of intelligence
기간: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Wechsler Intelligence Scale for Children, including verbal, performance and total scores, the average score is 100, with higher scores indicating higher than average intelligence and lower scores indicating lower levels of intelligence
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
change of functional performance
기간: changes from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Pediatric Outcome Data Collection Instrument
|
changes from baseline to 3 months of treatment, and 3 months after treatment
|
change of health-related quality of life
기간: changes from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Pediatric Quality of Life Inventory-Generic Core Scales, including physical, psychosocial, and total scores, with higher scores representing better health-related quality of life
|
changes from baseline to 3 months of treatment, and 3 months after treatment
|
공동 작업자 및 조사자
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. .
interactive cognitive training에 대한 임상 시험
-
Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention완전한
-
Dartmouth-Hitchcock Medical CenterCenters for Disease Control and Prevention모병
-
Guy's and St Thomas' NHS Foundation Trust모병
-
Dokuz Eylul UniversityThe Scientific and Technological Research Council of Turkey완전한
-
Seattle Children's HospitalLouisiana State University Health Sciences Center in New Orleans완전한
-
Douglas Mental Health University Institute모병