- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07720427
COMPARING EFFECTS OF NINTENDO EXERGAMING TO A NO INTERVENTION CONTROL GROUP
Exergaming Intervention Study
연구 개요
상태
개입 / 치료
상세 설명
Parents of each ASD participant completed a screening form and the parent and participant completed an additional screening interview before participating in a pretest visit to confirm study eligibility.
After the motor and cognitive pretests and parent questionnaires were completed and eligibility was confirmed, each participant was randomly assigned to the Nintendo exergaming (NE) intervention or no intervention control group.
Each participant in the NE group received 8 weeks of exergaming intervention for 45-60 minutes per session @2 sessions per week. After the intervention period was completed motor and cognitive posttests and parent questionnaires were completed to assess preliminary outcomes.
We also completed feasibility and acceptability measures using parent, trainer, and child surveys.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Delaware
-
Newark, Delaware, 미국, 19060
- Health Sciences Campus, University of Delaware
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- A school or medical record of holding an autism diagnosis
Exclusion Criteria:
- Did not follow 1 to 2-step instructions at the pretest.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Nintendo Switch Exergaming
This group received 8 weeks of Nintendo Switch Exergaming Intervention @ 2 days per week for 45-60 minutes per session.
Pretests and posttests were completed before and after this period.
|
Each exergaming intervention session included RingFit warm-up, RingFit Adventure Games to target multiple motor domains including body coordination, strength, and endurance and the Nintendo Switch Sports virtual sports targeted body coordination and visuomotor skills.
|
|
간섭 없음: No Intervention Control Group
This group received 8 weeks of business as usual control period.
Pretests and posttests were completed before and after this period.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bruininks Oseretsky Test of Motor Performance
기간: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
The BOT-2 is a standardized motor test that is a reliable and valid motor measure for youth between the ages of 4 to 21 years (Bruininks & Bruininks, 2005).
Participants' gross motor skills were assessed using the balance (BAL), bilateral coordination (BLC), strength (STN), and agility (AGIL) subtests of BOT-2.
Subtests are combined to provide a body coordination (BC, includes BAL and BLC), strength/agility (SA, includes STR and AGIL) and manual coordination (MC, includes MD and ULC) composite standard score at pretest and posttest.
Change in composite standard scores (BC, SA, and MC) were assessed between pretest and posttest performance.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bilateral Motor Coordination Subtest of there Sensory Integration and Praxis Test (SIPT-BMC) Battery
기간: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
The SIPT BMC subtest assesses a youth's ability to imitate 22 novel hand and feet rhythmic actions shown by the tester.
During the test, the tester asks the child to repeat bilateral rhythmic sequences of the hands or feet.
An error occurrs if the youth does correctly imitate the sequence or rhythm of the tester's movements.
A spatial error was scored if the youth's scale or pattern of movement differed from that of the tester.
A temporal error occurred if the youth paused during the motor sequence, or moved slow/fast compared to tester.
Total spatial and temporal errors were calculated across all imitated actions at pretest and posttest.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Developmental Coordination Disorder Questionnaire (DCD-Q)
기간: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
Parents completed the 15-item motor screening tool to report their child's fine- motor, gross-motor, and general coordination abilities compared to their peers.
The total score at pretest and posttest were compared.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Behavior Rating Inventory of Executive Function (BRIEF)
기간: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
Parents completed the BRIEF to assess the youth's executive functioning skills during everyday tasks.
The total score at pretest and posttest was compared.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Computerized Modified Flanker Task
기간: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
All participants completed the Modified Flanker Task to assess the inhibitory control component of executive functioning.
The task consisted of four experimental blocks, with incongruent and congruent conditions presented in random order within each block of 30 trials, with 15 incongruent and 15 congruent trials.
a) Congruent: Five fish facing in the same direction, b) Incongruent: The outer four fish faced the same direction while the center fish faced the opposite direction.
Participants were instructed to click the arrow button on the screen to indicate the direction of the center fish and to respond as quickly and accurately as possible.
We compared the average reaction time at pretest and posttest.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
|
Computerized Modified Stroop Word-Color Task
기간: Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
The Stroop Task assessed the task switching, flexibility, and response inhibition components of executive functioning.
The task consisted of two conditions: Color and Word.
Participants were instructed to press the button on the screen to match the color of the letters shown in the color condition, or to match the spelling of the word shown in the Word condition.
Each block consisted of 40 trials.
Average reaction times at pretest and posttest were compared.
|
Pretest and posttests were conducted within 2 weeks before or after intervention, respectively.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- 1947455
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. .
Autistic Youth, Nintendo Exergaming Group, No Intervention Control Group에 대한 임상 시험
-
Near East University, TurkeyAl-Ahli Hospital, Hebron모집하지 않고 적극적으로DVT 예방 | DVT - 심부 정맥 혈전증 | 심장 온펌프 수술 | DVT 예방 | On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications | 간호 관리 프로토콜키프로스
Nintendo Switch Exergaming에 대한 임상 시험
-
Universidad Rey Juan Carlos완전한
-
Universidad Rey Juan Carlos모병
-
Universidad de AlmeriaEuropean Union; Ministerio de Ciencia e Innovación, Spain모병
-
International Food Policy Research InstituteUNICEF; Kenyatta University모병
-
International Food Policy Research InstituteUNICEF; Ethiopian Public Health Association모병
-
University of South Carolina완전한
-
Centre Hospitalier Universitaire de Saint EtienneFondation de France종료됨