Clinical trial NCT06544317: Motor Intervention for Children With Developmental Coordination Disorder
Official title: Motor Intervention for Children With Developmental Coordination Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Developmental Coordination Disorder
Lead sponsor: Shanghai University of Medicine and Health Sciences
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study focuses on the effects of physical activity in schools on the cognitive function and physical fitness of children with and without developmental coordination disorder (DCD). Methods: 58 children with DCD participated in an 8-week exercise program. Children's standing broad jump (SBJ), 50m dash, 50m\*8 shuttle run, mental rotation and executive functions were assessed before and after training. A mixed-design analysis of variance (ANOVA) was conducted separately for each performance variable.

Detailed description: Potential children were identified from elementary schools in three districts of Shanghai. The study protocol was approved by the Ethics Committee of Shanghai Uni-versity of Medicine and Health Sciences. In order to select the research sample, recruitment letters were sent to the parents of all children; these letters detailed the purpose, significance and research process of the study, and a consent form was attached. If parents were willing to participate in the study, they were asked to sign the consent form and scan the QR code to fill in the questionnaire, including DCDQ, the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-VI and other personal information. All questionnaire contents were only accessible to research team members, and the researcher's name and telephone number were provided in case parents had questions. A total of 2,761 children and their parents volunteered to participate in this study. Children were screed using the Developmental Coordination Disorder Questionnaire (DCDQ) . Teachers selected those children with probable DCD but without any intellectual or cognitive impairment. These children were then tested using the Movement Assessment Battery for Children, 2nd edition. Finally, 116 pDCD children were randomly divided into a training group (TG, mean age 10.67 ± 1.25 years, 50 boys and 8 girls) and a control group (CG, mean age 10.27 ± 1.04 years, 48 boys and 10 girls) and gender matched typically developing (TD, mean age 10.35 ± 1.87 years; 48 boys and 12 girls) controls were included in the study. TG and TD will receive an additional 8 weeks of physical training intervention, while CG will not participate in the physical training intervention.

Eligibility criteria: Inclusion Criteria:

* DCDQ scores as follows: (8-9 years: \< 56 points; 10-12 years: \< 58 points)
* one subitem of the MABC-2 rank below 15%
* age 9 to 11 years old (elementary school age)

Exclusion Criteria:

* Children with other mental illness who are unable to exercise
* IQ \>90
* ADHD

Primary outcomes:
measure: Reaction time (RT) of mental rotation tasks
timeFrame: 8 weeks
measure: Reaction time (RT) of modified Stroop task
timeFrame: 8 weeks
measure: Standing broad jump
timeFrame: 8 weeks
measure: 50m sprint
timeFrame: 8 weeks
measure: 50m*8 shuttle run
timeFrame: 8 weeks
measure: Safety and Tolerability
timeFrame: 8 weeks
Secondary outcomes:
measure: Height
timeFrame: 8 weeks
measure: Weight
timeFrame: 8 weeks
Other outcomes:
measure: Safety and Tolerability
timeFrame: From enrollment until at least 12 weeks after completion of study treatment
Locations:
city: Shanghai
country: China
facility: Shanghai University of Medicine and Health Sciences
state: Pudong
Study officials:
References: