- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05079490
Motor Intervention for Preschooler With Motor Coordination Deficits
October 3, 2021 updated by: Fooyin University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kaohsiung, Taiwan
- Fooyin University
-
Contact:
- Li-Chiou Chen, PhD
- Phone Number: 7045 886-7-7811151
- Email: lichiou@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 4 to 6 years
- motor coordination competence < 15%ile comparing to norms for motor-deficit group or > 30%ile for healthy group
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Baseline
All children will receive outcome measures.
|
|
|
Experimental: Intervention phase
Children in the experimental group will receive intervention for 12 weeks while children in the control group remain their regular activities.
|
gross motor skill intervention combined with fitness training
|
|
No Intervention: Follow up phase
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
|
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
|
6 months
|
|
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
|
9 months
|
|
weight- post
Time Frame: 3 months
|
body weight (kg)
|
3 months
|
|
weight- follow1
Time Frame: 6 months
|
body weight (kg)
|
6 months
|
|
weight- follow2
Time Frame: 9 months
|
body weight (kg)
|
9 months
|
|
height- post
Time Frame: 3 months
|
body height (m)
|
3 months
|
|
height- follow1
Time Frame: 6 months
|
body height (m)
|
6 months
|
|
height- follow2
Time Frame: 9 months
|
body height (m)
|
9 months
|
|
flexibility- post
Time Frame: 3 months
|
sit-and-reach (cm)
|
3 months
|
|
flexibility- follow1
Time Frame: 6 months
|
sit-and-reach (cm)
|
6 months
|
|
flexibility- follow2
Time Frame: 9 months
|
sit-and-reach (cm)
|
9 months
|
|
strength- post
Time Frame: 3 months
|
long jump (cm)
|
3 months
|
|
strength- follow1
Time Frame: 6 months
|
long jump (cm)
|
6 months
|
|
strength- follow2
Time Frame: 9 months
|
long jump (cm)
|
9 months
|
|
aerobic fitness- post
Time Frame: 3 months
|
10 meter shuttle walk test (lap)
|
3 months
|
|
aerobic fitness- follow1
Time Frame: 6 months
|
10 meter shuttle walk test (lap)
|
6 months
|
|
aerobic fitness- follow2
Time Frame: 9 months
|
10 meter shuttle walk test (lap)
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-perceived motor competence- post
Time Frame: 3 months
|
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
|
3 months
|
|
self-perceived motor competence- follow1
Time Frame: 6 months
|
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
|
6 months
|
|
self-perceived motor competence- follow2
Time Frame: 9 months
|
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
|
9 months
|
|
daily time spent in physical activities- post
Time Frame: 3 months
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7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
|
3 months
|
|
daily time spent in physical activities- follow1
Time Frame: 6 months
|
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
|
6 months
|
|
daily time spent in physical activities- follow2
Time Frame: 9 months
|
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 15, 2021
Primary Completion (Anticipated)
August 31, 2024
Study Completion (Anticipated)
August 31, 2024
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
October 3, 2021
First Posted (Actual)
October 15, 2021
Study Record Updates
Last Update Posted (Actual)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSVGH20-CT5-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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