To investigate whether a computerized, motor intervention program, titled *Timocco* yields significant and clinically reliable improvements in motor function in very preterm children at five years corrected age (CA).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ontwikkelingsstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total score on the MABC-II-NL.
Secondary outcome
Secondary study parameters include visual-motor performance, attentional
functioning, school performance, and behavior of the child.
Visual-motor performance
- Balance board for balance skills
- Caterpillar Tracing task
- Beery Visual-Motor Integration test for visual-motor integration skills
Attentional functioning
- Stop signal task for inhibitory control, processing speed and variability in
speed
- Nutley visual working memory task for visual working memory
School performance
- Dutch Pupil Monitoring system scores
Behavior questionnaires parents
- Child Behavior Checklist (CBCL)
- Behavior Rating Inventory of Executive Function - preschool
- Early Language Scales
Behavior questionnaires teachers
- Teacher Report Form (TRF)
Background summary
At early school age, motor problems occur frequently in children born very
preterm Existing effective interventions, such as physical therapy, yield
short term benefits only and require parents and child to visit health care
institutions. Home-based, child-friendly computer training to remediate motor
problems in this population may be more easily accessible and longer lasting,
however, is efficacy is unknown.
Study objective
To investigate whether a computerized, motor intervention program, titled
*Timocco* yields significant and clinically reliable improvements in motor
function in very preterm children at five years corrected age (CA).
Study design
Randomized waitlist-controlled intervention study.
Intervention
Timocco® home-based computerized motor training program (www.Timocco.com).
Study burden and risks
Children whose parents provided informed consent will be assessed three times:
at FU (visit outpatient clinic for follow-up assessment at five years CA), at
home before start of the first trainingsession and at T1 (within one week after
the last training session). Both assessments include administration of tests
motor function, visual-motor function, attentional functioning, and behavior.
For the latter, parents and teachers will be asked to complete a questionnaire.
The Timocco home-based motor training program will entail a 12 week period with
three training sessions (±30 minutes each) per week. During a session, children
have to move a colourful gaming ball in order to successfully accomplish game
levels of various attractive games that are displayed on a computer screen.
The study examines an intervention that we hope yields positive effects for
children and parents. There is no risk related to participation and all study
and Timocco related activities are non-invasive. The risk of participation is
negligible.
*
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
Intervention and waitlist group: a standard score of <8 (<-1.0 SD) on the total
scale or one of the subscales of the M-ABC-II-NL
Reference group 1 (children born premature without motor problems): children
<32wk and/or <1500 grams, at 5 years CA with a standard score *8 on all the
scales of the Movement Assessment Battery for Children-II-NL (MABC-II-NL)
Reference group 2 (children born at term): children born at term (>37wk) and
with a birth weight of >2500 grams at the age of 5
Exclusion criteria
- severe vision problems
- diagnosis cerebral paresis, GMFCS II or higher
- IQ-score <70
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58428.018.16 |
| Other | Trial NL7568 |