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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 2 August 2023
Main ID:  ISRCTN23701994
Date of registration: 13/10/2016
Prospective Registration: No
Primary sponsor: University of Southern Denmark
Public title: Can we improve children's motor skills in preschool?
Scientific title: Effectiveness of a structured intervention for improving Motor skills in Danish PreSchool children: a randomised controlled trial
Date of first enrolment: 01/08/2016
Target sample size: 800
Recruitment status: Ongoing
URL:  https://www.isrctn.com/ISRCTN23701994
Study type:  Interventional
Study design:  Multi-centre cluster randomised controlled trial (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Denmark
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Lise    Hestbaek
Address:  University of Southern Denmark Campusvej 55 DK-5230 Odense M Denmark
Telephone: +45 (0)65 50 45 30
Email: lhestbaek@kiroviden.sdu.dk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: All children attending kindergarten in the municipality of Svendborg, Denmark
Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Motor skills
Musculoskeletal Diseases
Motor skills
Intervention(s)

Participating preschools are randomized, stratified by socioeconomic background (family-type (single parent, both parents etc.) and household income of the up-take area) to one of two groups

Intervention: At least four days a week (preferably five) participants take part in a minimum of 45-minutes of adult-initiated and adult-led activities, where all children participate. These activities challenge:
1. Motor function: This involves gross motor challenges such as creeping, crawling, running, jumping, hopscotch, jumping, climbing; fine motor challenges such as holding a pencil, handling small objects like beads and construction toys or catching insects; coordination exercises such as crawling exercises, cross-body movements, "Angels in the Snow", jumping jack and throwing, gripping and kicking exercises; and different dynamic and static balance exercises such as walking on a line and standing on one leg.
2. Sensing: The vestibular sense is stimulated for example by rolling, turning around, doing somersaults and swinging. The tactile sense is stimulated by touch from others, for example, in the form of massage and by touching various materials and objects of different size, shape and temperature. The kinaesthetic sense is stimulated by challenging the body's joints, muscles and tendons in different ways, for example, by bending, stretching and pushing, lifting objects of different weights and by fast and slow movements.
3. Relaxation: The children will also experience other types of physical stimulus, namely relaxation and unwinding. It can, for example, be through massage, children’s yoga or similar.
All pedagogues in the intervention pre-schools will go through a comprehen
Primary Outcome(s)
Gross and fine motor skills are measured using Movement Assessment Battery for Children (shuttle-run, 20m fast run and one-leg stance) at baseline, 6, 18 and 30 months
Secondary Outcome(s)

1. Perceived motor competence is measured using the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children at age six (last test before leaving pre-school)
2. Musculoskeletal disorder rate is measured through parent interviews via SMS every two weeks from baseline until study end. Additionally, ICD-10 diagnoses of persistent complaints (four weeks or more) will be made at an orthopaedic department as they occur throughout the study period
3. Physical activity is measured using axivity AX3 accelerometers (http://axivity.com/produdts/ax3) for six days at baseline, 6 months, 18 months and 30 months
4. General well-being is measured using the Strength and Difficulties Questionnaire, filled in electronically by both parents and teachers every six months from baseline
5. Language development is measured using Language assessment 3-6 which is administered by the preschool teachers at baseline and at school-start. The assessment battery consists of measures within two domains of language, i.e. oral language (Vocabulary, Comprehension, Communication strategies) and pre-literacy measures (Rhyme detection, Print awareness, Deletion and Letter identification)
6. Executive function is measured using three elements from Preschool Self-Regulation Assessment (balance beam, pencil tap and snack delay) at baseline, 6, 18 and 30 months
Secondary ID(s)
N/A
Source(s) of Monetary Support
TrygFonden, The Danish Chiropractors' Foundation
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Old ethics approval format; The Regional Committees on Health Research Ethics for Southern Denmark, 13/01/2016, ref: S-20150178
Results
Results available:
Date Posted:
Date Completed: 01/07/2029
URL:
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