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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05079490
Other study ID # KSVGH20-CT5-37
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2021
Est. completion date August 31, 2024

Study information

Verified date August 2021
Source Fooyin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
motor intervention
gross motor skill intervention combined with fitness training

Locations

Country Name City State
Taiwan Fooyin University Kaohsiung

Sponsors (2)

Lead Sponsor Collaborator
Fooyin University Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary weight- post body weight (kg) 3 months
Primary weight- follow1 body weight (kg) 6 months
Primary weight- follow2 body weight (kg) 9 months
Primary height- post body height (m) 3 months
Primary height- follow1 body height (m) 6 months
Primary height- follow2 body height (m) 9 months
Primary flexibility- post sit-and-reach (cm) 3 months
Primary flexibility- follow1 sit-and-reach (cm) 6 months
Primary flexibility- follow2 sit-and-reach (cm) 9 months
Primary strength- post long jump (cm) 3 months
Primary strength- follow1 long jump (cm) 6 months
Primary strength- follow2 long jump (cm) 9 months
Primary aerobic fitness- post 10 meter shuttle walk test (lap) 3 months
Primary aerobic fitness- follow1 10 meter shuttle walk test (lap) 6 months
Primary aerobic fitness- follow2 10 meter shuttle walk test (lap) 9 months
Secondary 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 3 months
Secondary 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 6 months
Secondary 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 9 months
Secondary daily time spent in physical activities- post 7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day) 3 months
Secondary daily time spent in physical activities- follow1 7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day) 6 months
Secondary daily time spent in physical activities- follow2 7-day averaged time spent in physical activities, recorded by activity monitor (minutes per day) 9 months
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