- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07771959
Play-Based Motor Training in Children Aged 7-10 Years (PBMT-DC)
Effects of an 8-Week Play-Based Motor Training Program on Motor Competence, Cognitive Test Performance, and Parent-Rated Executive Function in Children Aged 7-10 Years: A Randomized Controlled Trial
This randomized controlled study evaluated the effects of an 8-week structured play-based motor training program on motor competence in children (boys and girls) aged 7-10 years. Eighty eligible participants (40 boys and 40 girls) were individually randomized in a 1:1 ratio to an intervention group or a usual physical-education control group. The intervention consisted of 24 play-based motor-training sessions delivered three times per week for 60 minutes, whereas the control group continued usual physical education twice per week for 40 minutes. The primary outcome was motor competence assessed using the MABC-2 total score. Cognitive test performance measured using the Kay Cognitive-Diagnostic Test and parent-rated executive-function difficulties measured using the BRIEF Parent Form were exploratory secondary outcomes. Posttest outcomes were compared between groups using ANCOVA with the corresponding baseline score as a covariate. This study record was created retrospectively after completion of the study.
연구 개요
상태
상세 설명
The study was conducted during the 2025-2026 academic year in Dongchuan District, Yunnan Province, China. The sampling frame comprised approximately 100 children (50 boys and 50 girls) from four eligible classes across two primary schools. One hundred children were randomly selected by lottery for eligibility assessment. Twenty children were excluded before allocation: twelve because of physical or motor conditions that did not meet eligibility requirements, six because parental consent was not provided, and two because child assent was not obtained.
The remaining 80 eligible participants (40 boys and 40 girls) were individually randomized in a 1:1 ratio to the intervention or control group using a computer-generated random allocation sequence. Allocation was concealed using sequentially numbered, opaque, sealed envelopes prepared independently and opened after completion of baseline assessments.
The intervention group received an 8-week structured play-based motor-training program comprising 24 sessions, with three 60-minute sessions per week. Sessions included social interaction, warm-up, play-based motor activities, cool-down, and feedback. Main activities included coordinated movement with children's rhymes, animal-imitation games, running, jumping, throwing, rolling, and ball activities. The control group continued usual physical education twice weekly for approximately 40 minutes per session.
MABC-2 and Kay assessments were conducted by an independent trained assessor blinded to group allocation. Parents completing the BRIEF were not blinded. The primary outcome was the MABC-2 total score. Kay total score and BRIEF mean item score were treated as exploratory secondary outcomes. All 80 randomized participants completed posttest assessment. No serious or intervention-related adverse events were reported.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Yunnan
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Dongchuan, Yunnan, 중국, 654100
- Dongchuan, Yunnan, China
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children aged 7-10 years
- Enrolled in one of the eligible primary-school classes included in the study sampling frame
- Able to participate in regular school physical-education and play-based motor activities
- Written informed consent provided by a parent or legal guardian Child assent provided
Exclusion Criteria:
- A physical or motor condition that prevented safe or effective participation in the intervention or assessments
- Parental or guardian consent not provided
- Child assent not provided
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Structured Play-Based Motor Training
Participants received an 8-week structured play-based motor-training program consisting of three 60-minute sessions per week (24 sessions; 1,440 planned minutes). Each session included 5 minutes of social/introductory activity, 5 minutes of warm-up, 40 minutes of play-based motor activities, 5 minutes of cool-down, and 5 minutes of feedback. |
Participants in the intervention arm received an 8-week structured play-based motor training program delivered three times per week for 60 minutes per session, for a total of 24 sessions. Each session followed a standardized 60-minute format consisting of 5 minutes of social/introductory interaction, 5 minutes of warm-up activities, 40 minutes of structured play-based motor activities, 5 minutes of cool-down, and 5 minutes of feedback. The main activity component included coordinated movements accompanied by children's rhymes, animal-imitation games, and fundamental motor activities such as running, jumping, throwing, rolling, and simple ball-handling tasks. Activities were delivered in a game-based format and emphasized active participation, movement exploration, coordination, and repeated practice of fundamental movement skills. The intervention replaced the participants' usual physical-education sessions during the study period. |
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활성 비교기: Usual Physical Education
Participants continued their usual school physical-education program consisting of two approximately 40-minute sessions per week, including general fitness activities, running, stretching, and simple recreational games, without the structured play-based motor-training protocol. |
Participants in the control arm continued their usual school physical-education program throughout the 8-week study period. Usual physical education was delivered twice per week for approximately 40 minutes per session and included general fitness activities, running, stretching, and simple recreational games. The control program did not include the structured play-based motor training protocol, the standardized 5+5+40+5+5 session format, or the systematic motor-practice activities used in the intervention arm. Control sessions were scheduled separately from the intervention sessions, and control participants did not observe the structured intervention activities. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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MABC-2 Total Score
기간: Baseline and approximately 9 weeks after baseline (one week after completion of the 8-week intervention)
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Motor competence was assessed using the Movement Assessment Battery for Children, Second Edition (MABC-2), using the age-appropriate Age Band 2 procedures. The MABC-2 total score was used as the primary motor-performance outcome. Higher scores indicate better motor performance. The primary statistical comparison used posttest scores adjusted for the corresponding baseline score using ANCOVA. |
Baseline and approximately 9 weeks after baseline (one week after completion of the 8-week intervention)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Kay Cognitive-Diagnostic Test Total Score
기간: Baseline and approximately 9 weeks after baseline
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Cognitive test performance was assessed using the Kay Cognitive-Diagnostic Test. Five subtests assessed concept formation, symbolic thinking, socialization of thought, visual-motor perception, and short-term attention/psychomotor speed. The total score ranges theoretically from 0 to 100, with higher scores indicating better performance. A translated Chinese version was used without formal age-specific validation; therefore, this outcome was considered exploratory. |
Baseline and approximately 9 weeks after baseline
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BRIEF Parent-Form Mean Item Score
기간: Baseline and approximately 9 weeks after baseline
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Executive-function difficulties were assessed using the 86-item Chinese parent form of the Behavior Rating Inventory of Executive Function (BRIEF). Items were rated from 1 (never) to 3 (often), and the mean item score was calculated across the 86 items. Higher scores indicate greater parent-rated executive-function difficulties. The same parent or caregiver completed the questionnaire at baseline and posttest. This was an exploratory secondary outcome. |
Baseline and approximately 9 weeks after baseline
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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
기타 연구 ID 번호
- PBMT-DONGCHUAN-2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data are not publicly available because of ethical and confidentiality restrictions. Requests for access to de-identified data may be considered on a case-by-case basis by the corresponding author, subject to approval by the relevant institutional and ethics authorities and applicable confidentiality requirements.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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