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ID
Source
Brief title
Health condition
motor problems after very preterm birth
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total score on the M-ABC-II-NL
Secondary outcome
Secondary study parameters include visual-motor performance, executive and attentional functioning, language skills, school performance, and behavior of the child
Background summary
Rationale: 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 at least as effective.
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.
Study population: Children <320wk and/or <15000 grams, at 5 years CA with a standard score <8 (i.e. <1.0 SD) on the total scale or one of the subscales of the Movement Assessment Battery for Children-II-NL (MABC-II-NL).
Participating Centers: Academic Medical Centre Amsterdam, The Netherlands; VU University Medical Centre Amsterdam and University Medical Center Groningen
Intervention (if applicable): Timocco® home-based computerized motor training program.
Main study parameters/endpoints: Total score on the M-ABC-II-NL.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Children whose parents provided informed consent will be assessed three times: at follow-up (FU) at the outpatient clinic for follow-up assessment at five years CA, at home before start of the first training session (T1) and within one week after the last training session (T2). Both assessments include administration of tests for 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 colorful gaming ball in order to successfully accomplish game levels of various attractive games that are displayed on a computer screen. As a parent is required to support the child during the playful training session, this program is family-integrated.
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.
Study objective
Motor training with Timocco Training Program significantly improves motor function assessed by the M-ABC.
Study design
T0, T1
Intervention
Timocco® home-based computerized motor training program.
Cornelieke Aarnoudse-Moens
0031205661088
c.aarnoudse-moens@amc.uva.nl
Cornelieke Aarnoudse-Moens
0031205661088
c.aarnoudse-moens@amc.uva.nl
Inclusion criteria
- a standard score of <8 (i.e.,<1.0 SD) on the total scale or one of the subscales of the M-ABC-II-NL (a standard score of <8 on the M-ABC-II-NL indicates difficulties with handwriting, aiming and catching, and poor balance skills. Children with severe motor impairments such as CP are not assessed with the M-ABC-II).
Exclusion criteria
- severe vision problems
- diagnosis cerebral paresis, GMFCS II or higher
- IQ-score <70
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL7568 |
Other | TIMOCCO Tel: 1-330-968-2879 526 South Main St. Suite 709A Akron, OH 44311 : METC 2016_259 |