Main
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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:
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ISRCTN |
Last refreshed on:
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2 August 2023 |
Main ID: |
ISRCTN23701994 |
Date of registration:
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13/10/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Can we improve children's motor skills in preschool?
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Scientific title:
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Effectiveness of a structured intervention for improving Motor skills in Danish PreSchool children: a randomised controlled trial |
Date of first enrolment:
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01/08/2016 |
Target sample size:
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800 |
Recruitment status: |
Ongoing |
URL:
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https://www.isrctn.com/ISRCTN23701994 |
Study type:
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Interventional |
Study design:
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Multi-centre cluster randomised controlled trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Lise
Hestbaek |
Address:
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University of Southern Denmark
Campusvej 55
DK-5230
Odense M
Denmark |
Telephone:
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+45 (0)65 50 45 30 |
Email:
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lhestbaek@kiroviden.sdu.dk |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Motor skills Musculoskeletal Diseases Motor skills
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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TrygFonden, The Danish Chiropractors' Foundation
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; The Regional Committees on Health Research Ethics for Southern Denmark, 13/01/2016, ref: S-20150178
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Results
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Results available:
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Date Posted:
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Date Completed:
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01/07/2029 |
URL:
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