NCT05079490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 15, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

August 31, 2021

Last Update Submit

October 3, 2021

Conditions

Developmental Coordination Disorder

Outcome Measures

Primary Outcomes (18)

  • 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

    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

    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

    9 months

  • weight- post

    body weight (kg)

    3 months

  • weight- follow1

    body weight (kg)

    6 months

  • weight- follow2

    body weight (kg)

    9 months

  • height- post

    body height (m)

    3 months

  • height- follow1

    body height (m)

    6 months

  • height- follow2

    body height (m)

    9 months

  • flexibility- post

    sit-and-reach (cm)

    3 months

  • flexibility- follow1

    sit-and-reach (cm)

    6 months

  • flexibility- follow2

    sit-and-reach (cm)

    9 months

  • strength- post

    long jump (cm)

    3 months

  • strength- follow1

    long jump (cm)

    6 months

  • strength- follow2

    long jump (cm)

    9 months

  • aerobic fitness- post

    10 meter shuttle walk test (lap)

    3 months

  • aerobic fitness- follow1

    10 meter shuttle walk test (lap)

    6 months

  • aerobic fitness- follow2

    10 meter shuttle walk test (lap)

    9 months

Secondary Outcomes (6)

  • self-perceived motor competence- post

    3 months

  • self-perceived motor competence- follow1

    6 months

  • self-perceived motor competence- follow2

    9 months

  • daily time spent in physical activities- post

    3 months

  • daily time spent in physical activities- follow1

    6 months

  • +1 more secondary outcomes

Study Arms (3)

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.

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.

Interventions

motor interventionBEHAVIORAL

gross motor skill intervention combined with fitness training

Intervention phase

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged 4 to 6 years
  • motor coordination competence \< 15%ile comparing to norms for motor-deficit group or \> 30%ile for healthy group

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fooyin University

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

October 15, 2021

Study Start

October 15, 2021

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

October 15, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)