Developmental Coordination DisorderNCT05079490
Motor Intervention for Preschooler With Motor Coordination Deficits
A study testing motor intervention in people with Developmental Coordination Disorder, run by Fooyin University at 1 site in Taiwan.
Trial summary
This research project aims to examine the impact of motor coordination deficits and the effects of motor intervention on preschool-aged children's perceived competence, health-related physical fitness, activity participation and physical activity. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- motor intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2021to 31 Aug 2024
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 4 to 6 years
- motor coordination competence < 15%ile comparing to norms for motor-deficit group or > 30%ile for healthy group
Who cannot join
- genetic and chromosome deficits
- neurological or neuromuscular disorders
- congenital musculoskeletal disorders
- fracture in the past 6 months
- other conditions that affect the child's participation in physical activities
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fooyin University
Kaohsiung City
Li-Chiou Chen, PhD, 886-7-7811151 ext. 7045, lichiou@gmail.com
About this study
Official title: Impact of Motor Coordination Deficits in Preschool Children: Effects of Motor Intervention
This research project aims to examine the impact of motor coordination deficits and the effects of motor intervention on preschool-aged children's perceived competence, health-related physical fitness, activity participation and physical activity. Eighty children, aged 4-6 years,with or without motor coordination deficits will be recruited and assigned to to motor intervention (DCD-t), control 1 (DCD-c) or control 2 (TD) group. Children in the intervention group will receive motor intervention for 12 weeks. All children will be assessed at baseline, 0-, 3- and 6-month post-intervention.
Read the detailed description
This research project aims to examine the impact of motor coordination deficits on preschool-aged children's perceived competence, health-related physical fitness, activity participation and physical activity. Furthermore, the investigators are to investigate the effects of motor intervention on children's competence and participation during preschool age. This study plans to recruit 40 children with motor coordination deficits, aged 4-6 years, and 40 age- and gender-matched typically developing children. Children with motor coordination deficits will further be randomly assigned to motor intervention (DCD-t) or control (DCD-c) group. At baseline assessment, all children will be assessed for motor coordination competence, self-perception of competence, health-related physical fitness and daily activity participation. Physical activity will also be quantitatively measured using accelerometry. During the intervention phase, children in the DCD-t group will receive task-oriented motor intervention combined with fitness training three times per week while children in the DCD-c group remain usual activities. All children will be re-assessed at 0-, 3- and 6-month post-intervention. Repeated Measures ANOVA will be applied to examine the differences of motor competence, self-perception, fitness and activity participation among the 3 groups of children and over the 9-month period. The effects of motor intervention on DCD children's competence and participation will also be examined.
- Conditions
- Developmental Coordination Disorder
- Being tested
- motor intervention
- 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.
motor interventionBehavioural
gross motor skill intervention combined with fitness training
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | All children will receive outcome measures. |
| Intervention phase | Experimental | Children in the experimental group will receive intervention for 12 weeks while children in the control group remain their regular activities. Receives: Behavioral: motor intervention |
| Follow up phase | No intervention | All children will be followed after the end of intervention phase and receive outcome measures at 3- and 6-month after the completion of intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor coordination competence- post
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
Measured: 3 months
motor coordination competence- follow1
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
Measured: 6 months
motor coordination competence- follow2
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
Measured: 9 months
weight- post
body weight (kg)
Measured: 3 months
weight- follow1
body weight (kg)
Measured: 6 months
weight- follow2
body weight (kg)
Measured: 9 months
height- post
body height (m)
Measured: 3 months
height- follow1
body height (m)
Measured: 6 months
height- follow2
body height (m)
Measured: 9 months
flexibility- post
sit-and-reach (cm)
Measured: 3 months
flexibility- follow1
sit-and-reach (cm)
Measured: 6 months
flexibility- follow2
sit-and-reach (cm)
Measured: 9 months
strength- post
long jump (cm)
Measured: 3 months
strength- follow1
long jump (cm)
Measured: 6 months
strength- follow2
long jump (cm)
Measured: 9 months
aerobic fitness- post
10 meter shuttle walk test (lap)
Measured: 3 months
aerobic fitness- follow1
10 meter shuttle walk test (lap)
Measured: 6 months
aerobic fitness- follow2
10 meter shuttle walk test (lap)
Measured: 9 months
Secondary outcomes (6)
self-perceived motor competence- post
scores of Physical Competence Subscale of the The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children; score range 6~24, a higher score indicates a better outcome
Measured: 3 months
self-perceived motor competence- follow1
scores of Physical Competence Subscale of the The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children; score range 6~24, a higher score indicates a better outcome
Measured: 6 months
self-perceived motor competence- follow2
scores of Physical Competence Subscale of the The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children; score range 6~24, a higher score indicates a better outcome
Measured: 9 months
daily time spent in physical activities- post
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
Measured: 3 months
daily time spent in physical activities- follow1
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
Measured: 6 months
daily time spent in physical activities- follow2
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079490
- Sponsor's protocol ID
- KSVGH20-CT5-37
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Motor Coordination Deficits in Preschool Children: Effects of Motor Intervention
- ClinicalTrials.gov ID
- NCT05079490
- Acronym / sponsor ID
- KSVGH20-CT5-37
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital.
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 15 Oct 2021 (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 research project aims to examine the impact of motor coordination deficits and the effects of motor intervention on preschool-aged children's perceived competence, health-related physical fitness, activity participation and physical activity. Eighty children, aged 4-6 years,with or without motor coordination deficits will be recruited and assigned to to motor intervention (DCD-t), control 1 (DCD-c) or control 2 (TD) group. Children in the intervention group will receive motor intervention for 12 weeks. All children will be assessed at baseline, 0-, 3- and 6-month post-intervention.
Detailed description
This research project aims to examine the impact of motor coordination deficits on preschool-aged children's perceived competence, health-related physical fitness, activity participation and physical activity. Furthermore, the investigators are to investigate the effects of motor intervention on children's competence and participation during preschool age. This study plans to recruit 40 children with motor coordination deficits, aged 4-6 years, and 40 age- and gender-matched typically developing children. Children with motor coordination deficits will further be randomly assigned to motor intervention (DCD-t) or control (DCD-c) group. At baseline assessment, all children will be assessed for motor coordination competence, self-perception of competence, health-related physical fitness and daily activity participation. Physical activity will also be quantitatively measured using accelerometry. During the intervention phase, children in the DCD-t group will receive task-oriented motor intervention combined with fitness training three times per week while children in the DCD-c group remain usual activities. All children will be re-assessed at 0-, 3- and 6-month post-intervention. Repeated Measures ANOVA will be applied to examine the differences of motor competence, self-perception, fitness and activity participation among the 3 groups of children and over the 9-month period. The effects of motor intervention on DCD children's competence and participation will also be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –All children will receive outcome measures. |
| Intervention phase | Experimental | Behavioral: motor interventionChildren in the experimental group will receive intervention for 12 weeks while children in the control group remain their regular activities. |
| Follow up phase | No intervention | –All children will be followed after the end of intervention phase and receive outcome measures at 3- and 6-month after the completion of intervention. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 4 to 6 years
- motor coordination competence < 15%ile comparing to norms for motor-deficit group or > 30%ile for healthy group
Key exclusion criteria (5 listed)
- genetic and chromosome deficits
- neurological or neuromuscular disorders
- congenital musculoskeletal disorders
- fracture in the past 6 months
- other conditions that affect the child's participation in physical activities
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 |
|---|---|---|
| motor interventiongross motor skill intervention combined with fitness training | Behavioural | Intervention phase |
Primary outcome
motor coordination competence- post
Time frame: 3 months
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
motor coordination competence- follow1
Time frame: 6 months
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
motor coordination competence- follow2
Time frame: 9 months
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
weight- post
Time frame: 3 months
body weight (kg)
weight- follow1
Time frame: 6 months
body weight (kg)
weight- follow2
Time frame: 9 months
body weight (kg)
height- post
Time frame: 3 months
body height (m)
height- follow1
Time frame: 6 months
body height (m)
height- follow2
Time frame: 9 months
body height (m)
flexibility- post
Time frame: 3 months
sit-and-reach (cm)
flexibility- follow1
Time frame: 6 months
sit-and-reach (cm)
flexibility- follow2
Time frame: 9 months
sit-and-reach (cm)
strength- post
Time frame: 3 months
long jump (cm)
strength- follow1
Time frame: 6 months
long jump (cm)
strength- follow2
Time frame: 9 months
long jump (cm)
aerobic fitness- post
Time frame: 3 months
10 meter shuttle walk test (lap)
aerobic fitness- follow1
Time frame: 6 months
10 meter shuttle walk test (lap)
aerobic fitness- follow2
Time frame: 9 months
10 meter shuttle walk test (lap)
6 secondary outcomes
self-perceived motor competence- post
Time frame: 3 months
self-perceived motor competence- follow1
Time frame: 6 months
self-perceived motor competence- follow2
Time frame: 9 months
daily time spent in physical activities- post
Time frame: 3 months
daily time spent in physical activities- follow1
Time frame: 6 months
daily time spent in physical activities- follow2
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor intervention in people with Developmental Coordination Disorder, run by Fooyin University at 1 site in Taiwan.
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 2 inclusion and 5 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 15 Oct 2021. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor coordination competence- post (time frame: 3 months). The study lists 18 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 15 Oct 2021.