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Motor Intervention for Preschooler With Motor Coordination Deficits

Primary Purpose

Developmental Coordination Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
motor intervention
Sponsored by
Fooyin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Coordination Disorder

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fooyin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Baseline

Intervention phase

Follow up phase

Arm Description

All children will receive outcome measures.

Children in the experimental group will receive intervention for 12 weeks while children in the control group remain their regular activities.

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.

Outcomes

Primary Outcome Measures

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
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
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
weight- post
body weight (kg)
weight- follow1
body weight (kg)
weight- follow2
body weight (kg)
height- post
body height (m)
height- follow1
body height (m)
height- follow2
body height (m)
flexibility- post
sit-and-reach (cm)
flexibility- follow1
sit-and-reach (cm)
flexibility- follow2
sit-and-reach (cm)
strength- post
long jump (cm)
strength- follow1
long jump (cm)
strength- follow2
long jump (cm)
aerobic fitness- post
10 meter shuttle walk test (lap)
aerobic fitness- follow1
10 meter shuttle walk test (lap)
aerobic fitness- follow2
10 meter shuttle walk test (lap)

Secondary Outcome Measures

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
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
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
daily time spent in physical activities- post
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
daily time spent in physical activities- follow1
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
daily time spent in physical activities- follow2
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)

Full Information

First Posted
August 31, 2021
Last Updated
October 3, 2021
Sponsor
Fooyin University
Collaborators
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT05079490
Brief Title
Motor Intervention for Preschooler With Motor Coordination Deficits
Official Title
Impact of Motor Coordination Deficits in Preschool Children: Effects of Motor Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2021 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fooyin University
Collaborators
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
All children will receive outcome measures.
Arm Title
Intervention phase
Arm Type
Experimental
Arm Description
Children in the experimental group will receive intervention for 12 weeks while children in the control group remain their regular activities.
Arm Title
Follow up phase
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
motor intervention
Intervention Description
gross motor skill intervention combined with fitness training
Primary Outcome Measure Information:
Title
motor coordination competence- post
Description
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
Time Frame
3 months
Title
motor coordination competence- follow1
Description
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
Time Frame
6 months
Title
motor coordination competence- follow2
Description
percentile scores of Movement Assessment Battery for Children, Second Edition; score range 1~99, a higher score indicates a better outcome
Time Frame
9 months
Title
weight- post
Description
body weight (kg)
Time Frame
3 months
Title
weight- follow1
Description
body weight (kg)
Time Frame
6 months
Title
weight- follow2
Description
body weight (kg)
Time Frame
9 months
Title
height- post
Description
body height (m)
Time Frame
3 months
Title
height- follow1
Description
body height (m)
Time Frame
6 months
Title
height- follow2
Description
body height (m)
Time Frame
9 months
Title
flexibility- post
Description
sit-and-reach (cm)
Time Frame
3 months
Title
flexibility- follow1
Description
sit-and-reach (cm)
Time Frame
6 months
Title
flexibility- follow2
Description
sit-and-reach (cm)
Time Frame
9 months
Title
strength- post
Description
long jump (cm)
Time Frame
3 months
Title
strength- follow1
Description
long jump (cm)
Time Frame
6 months
Title
strength- follow2
Description
long jump (cm)
Time Frame
9 months
Title
aerobic fitness- post
Description
10 meter shuttle walk test (lap)
Time Frame
3 months
Title
aerobic fitness- follow1
Description
10 meter shuttle walk test (lap)
Time Frame
6 months
Title
aerobic fitness- follow2
Description
10 meter shuttle walk test (lap)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
self-perceived motor competence- post
Description
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
Time Frame
3 months
Title
self-perceived motor competence- follow1
Description
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
Time Frame
6 months
Title
self-perceived motor competence- follow2
Description
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
Time Frame
9 months
Title
daily time spent in physical activities- post
Description
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
Time Frame
3 months
Title
daily time spent in physical activities- follow1
Description
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
Time Frame
6 months
Title
daily time spent in physical activities- follow2
Description
7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fooyin University
City
Kaohsiung
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Chiou Chen, PhD
Phone
886-7-7811151
Ext
7045
Email
lichiou@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Motor Intervention for Preschooler With Motor Coordination Deficits

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