Developmental Coordination DisorderNCT06544317
Motor Intervention for Children With Developmental Coordination Disorder
A study testing physical training in people with Developmental Coordination Disorder, run by Zhiguang Ji at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- Children with other mental illness who are unable to exercise
- IQ >90
- ADHD
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Medicine and Health Sciences
Shanghai, Pudong, 201318
About this study
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.
Read the 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.
- Conditions
- Developmental Coordination Disorder
- Being tested
- physical training
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical trainingBehavioural
All children received a series of 90-minute sessions 3 times a week for 8 weeks of after-school physical training. Each session began with a warm-up (20 min), three or four tasks related to the skill to be developed (aerobic training, resistance training, other activities designed to improve motor skills and balance, stretching and flexibility activities and core strength and posture exercises; 60 min) and a cool-down (10 min). Children were divided into six groups, with the number of children in each group ranging from eight to twelve.
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | Not described Receives: Behavioral: physical training |
| control group | No intervention | Not described |
| typically developing | Active comparator | Not described Receives: Behavioral: physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (RT) of mental rotation tasks
The experiment involved simultaneously presenting children with two pictures of "giraffes". The image on the left was fixed as the target, and the image on the right showed angle or mirror differences. The angular disparities were 0°, 60°, 120° or 180°. Through rotation, the children were asked to determine, as quickly and accurately as possible, whether the two images were identical.
Measured: 8 weeks
Reaction time (RT) of modified Stroop task
The computerized modified Stroop task includes the following two conditions: a naming (non-execution) and execution condition. In the naming condition, the screen will display a colored "XXX" and the children need to press the key corresponding to the color. In the execution condition, the stimulus will show a distracting-colored word, similar to the classic Stroop, showing Chinese characters in either blue or red; in this test, the children need to press the key corresponding to the color of the word, rather than the meaning of the Chinese character. When the color of the word is consistent with its meaning, the condition is congruent; when the color of the word is inconsistent with its meaning, it is the condition is incongruent.
Measured: 8 weeks
Standing broad jump
The SBJ test, which is completed on a flat surface, is used to evaluate the explosive strength of the lower limbs.
Measured: 8 weeks
50m sprint
The 50m sprint test requires students to start in a standing position and complete a 50m sprint with all their strength. The test is conducted twice, and the fastest result is recorded.
Measured: 8 weeks
50m*8 shuttle run
children are required to run back and forth between two points as quickly as possible.
Measured: 8 weeks
Safety and Tolerability
There were no safety and adverse events
Measured: 8 weeks
Secondary outcomes (2)
Height
Height was measured to the nearest 0.1 cm (Shanghe SH-200G, China)
Measured: 8 weeks
Weight
weight was measured to the nearest 0.1 kg using a portable stadiometer (Shanghe SH-200G, China).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiguang Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiguang Ji, Shanghai University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544317
- Sponsor's protocol ID
- ShanghaiUMHS
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This experiment is still in progress as other research and can be made public at the appropriate time.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Intervention for Children With Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT06544317
- Acronym / sponsor ID
- ShanghaiUMHS
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhiguang JiUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Behavioral: physical training |
| control group | No intervention | – |
| typically developing | Active comparator | Behavioral: physical training |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Children with other mental illness who are unable to exercise
- IQ >90
- ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical trainingAll children received a series of 90-minute sessions 3 times a week for 8 weeks of after-school physical training. Each session began with a warm-up (20 min), three or four tasks related to the skill to be developed (aerobic training, resistance training, other activities designed to improve motor skills and balance, stretching and flexibility activities and core strength and posture exercises; 60 min) and a cool-down (10 min). Children were divided into six groups, with the number of children in each group ranging from eight to twelve. | Behavioural | training group, typically developing |
Primary outcome
Reaction time (RT) of mental rotation tasks
Time frame: 8 weeks
The experiment involved simultaneously presenting children with two pictures of "giraffes". The image on the left was fixed as the target, and the image on the right showed angle or mirror differences. The angular disparities were 0°, 60°, 120° or 180°. Through rotation, the children were asked to determine, as quickly and accurately as possible, whether the two images were identical.
Reaction time (RT) of modified Stroop task
Time frame: 8 weeks
The computerized modified Stroop task includes the following two conditions: a naming (non-execution) and execution condition. In the naming condition, the screen will display a colored "XXX" and the children need to press the key corresponding to the color. In the execution condition, the stimulus will show a distracting-colored word, similar to the classic Stroop, showing Chinese characters in either blue or red; in this test, the children need to press the key corresponding to the color of the word, rather than the meaning of the Chinese character. When the color of the word is consistent with its meaning, the condition is congruent; when the color of the word is inconsistent with its meaning, it is the condition is incongruent.
Standing broad jump
Time frame: 8 weeks
The SBJ test, which is completed on a flat surface, is used to evaluate the explosive strength of the lower limbs.
50m sprint
Time frame: 8 weeks
The 50m sprint test requires students to start in a standing position and complete a 50m sprint with all their strength. The test is conducted twice, and the fastest result is recorded.
50m*8 shuttle run
Time frame: 8 weeks
children are required to run back and forth between two points as quickly as possible.
Safety and Tolerability
Time frame: 8 weeks
There were no safety and adverse events
2 secondary outcomes
Height
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided. This experiment is still in progress as other research and can be made public at the appropriate time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical training in people with Developmental Coordination Disorder, run by Zhiguang Ji at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (RT) of mental rotation tasks (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.