LEARN 2 MOVE 0-2 years

The study

In LEARN 2 MOVE 0-2 years (L2M0-2) the effect of the novel intervention program COPCA (Coping with and caring for infants with special needs – a family centered program, Dirks & Hadders-Algra) in infants at high risk for cerebral palsy (CP) is compared to that of traditional paediatric physical therapy. We assess the effect on function of the infant and the family. The previous VIP project (Dutch: Vroegtijdig Interventie Project) in another group high risk infants indicated that COPCA may contribute to beneficial outcome (see VIP-project).


Design of the study

Participants:

40 infants, corrected age at start of the study 1-9 months and at high risk for CP

Inclusion criteria:
  • Cystic periventricular leukomalacia (cPVL)
  • Uni- of bilateral parenchymal haemorrhage
  • Uni- of bilateral parenchymal infarction
  • Severe perinatal asphyxia (Sarnat 2-3) with indications for brain damage on MRI
  • Neurological dysfunction indicating development of CP
Exclusion criteria
  • Severe congenital abnormalities
  • Parents with insufficient mastery of the Dutch language

Recruitment area: Groningen, Friesland, Drenthe, Overijssel and area around Amsterdam

Intervention:

Random assignment to COPCA or traditional infant physiotherapy. Assignment is carried out by Tineke Dirks, developmental physiotherapist; Ms. Dirks coordinates the communication between therapists, parents and paediatricians. She is the only person in the research team who knows group membership of the participants.

In each area some physiotherapists have been taught principles of COPCA. The contents of the COPCA program is not generally available, as its efficacy is still under review.

Duration of the intervention: 1 year.

Frequency of intervention: once a week for infants receiving COPCA. We aim to have a similar frequency of intervention in the control group.

Evaluation:

  • By means of an extensive test battery, evaluation of function of the child (motor function, cognition) family function, parent-infant interaction and the way in which physiotherapy is implemented (video-recording of therapy sessions).
  • Evaluation is carried out at baseline and after 3, 6 and 12 months after the onset of intervention and – when this did not coincide with the evaluation after 12 months) – at the corrected age of 21 months.
  • Long term follow-up at school age started in January 2018.

Current status:

Developmental outcome in both groups was similar – just as in the VIP-project. Yet, the COPCA approach was associated with a better family empowerment.
Meanwhile we learned about development of infants at very high risk for cerebral palsy. This resulted in the following:

  • a proposal for adaptation of the Gross Motor Function Measure (GMFM) for children below the age of 2 years;
  • the discovery that a slow pupillary reaction in response to light in very high risk infants is associated with specific lesions of the brain and with a less favorable developmental outcome;
  • the finding that young infants at very high risk of cerebral palsy more often than typically developing infants show a tonic reaction in response to the knee jerk. The presence of tonic responses is associated with abnormal GMs and an increased risk of cerebral palsy.
  • Infants at very high risk of cerebral palsy who are later diagnosed with cerebral palsy show from early age onwards worse kinematic reaching quality and head stability than very high risk infants who are not diagnosed with cerebral palsy.
  • In contrast to typically developing infants, infants at very high risk of cerebral palsy do not show an increase in direction-specific postural adjustments during the first 1.5 years post term.

Collaborators

Mijna Hadders-Algra, MD, PhD
Developmental Neurology

Arend F Bos, MD, PhD
Neonatology, UMCG

Anke Boxum, MD,PhD
Developmental Neurology

Tineke Dirks, PT
Developmental Neurology

Linze J. Dijkstra
Developmental Neurology

Jan Geertzen, MD, PhD
Centre for Rehabilitation, UMCG

Elisa G. Hamer, MD, PhD
Developmental Neurology

Tjitske Hielkema, MD, PhD
Centre for Rehabilitation & Developmental Neurology

Karel G.B. Maathuis, MD, PhD
Centre for Rehabilitation, UMCG

Heleen A. Reinders-Messelink, PhD
Centre for Rehabilitation, UMCG / Rehabilitation Friesland
Lilian Straathof, MD, MD/PhD student
Developmental Neurology

Johannes Verheijden
BOSK

Carla Vlaskamp, PhD
Special Education, RUG

Key publications

  • Hielkema T, Hamer EG, Reinders-Messelink HA, Maathuis CGB, Bos AF, Dirks T, Van Doormaal L, Verheijden JMA, Vlaskamp C, Lindeman E, Hadders-Algra M. Learn 2 move 0-2 years: effects controlled trial. BMC Pediatrics, 2010, 10:76
  • Hielkema T, Hamer EG, Ebbers-Dekkers I, Dirks T, Maathuis CGB, Reinders-Messelink HA, of a new intervention program in infants at very high risk for cerebral palsy – a randomized Geertzen JHB, Hadders-Algra M. GMFM in infancy: age-pecific limitations and adaptations. Pediatr Phys Ther 2013; 25:168-76.
  • Boxum AG, Van Balen LC, Dijktra LJ, Hamer EG, Hielkema T, Reinders-Messelink HA, Hadders-Algra M. Postural adjustments in infants at very high risk for cerebral palsy before and after developing the ability to sit independently. Early Hum Dev 2014;90:435-41.
  • Hamer EG, Dijkstra LJ, Hooijsma SJ, Zijdewind I, Hadders-Algra M. Knee jerk responses in infants at high risk for cerebral palsy: an observational EMG study. Pediatr Res. 2016; 80: 363-70.
  • Hamer EG, Vermeulen RJ, Dijkstra LJ, Hielkema T, Kos C, Bos AF, Hadders-Algra M. Slow pupillary light response in infants at high risk for cerebral palsy were associated with periventricular leukomalacia and neurological outcome. Acta Paediatr. 2016; 105: 1493-1501.
  • Hadders-Algra M, Boxum AG, Hielkema T, Hamer EG. Effect of early intervention in infants at very high risk of cerebral palsy – a systematic review. Dev Med Child Neurol 2017;59:246-58.
  • Boxum AG, La Bastide-Van Gemert S, Dijkstra LJ, Hamer EG, Hielkema T, Reinders-Messelink HA, Hadders-Algra M. Development of the quality of reaching in infants with cerebral palsy: a kinematic study. Dev Med Child Neurol. 2017; 59: 1164-1173.
  • Van Balen LC, Boxum AG, Dijkstra LJ, Hamer EG, Hielkema T, Reinders-Messelink HA, Hadders-Algra M. Are postural adjustments during reaching related to walking development in typically developing infants and infants at risk of cerebral palsy? Infant Behav Dev. 2018; 50: 107-115.
  • Hamer E, La Bastide-Van Gemert S, Boxum A, Dijkstra L, Hielkema T, Vermeulen RJ, Hadders-Algra M. The tonic response to the infant knee jerk as an early sign of cerebral palsy. Early Hum Dev. 2018; 119: 38-44.
  • Hielkema T, Toonen RF, Hooijsma SJ, Dirks T, Reinders-Messelink HA, Maathuis CGB, Geertzen JHB, Hadders-Algra M. Changes in the content of pediatric physical therapy for infants: a quantitative, observational study. Phys Occup Ther Pediatr. 2018; 38:457-88.
  • Boxum AG, Dijkstra LJ, la Bastide-van Gemert S, Hamer EG, Hielkema T, Reinders-Messelink HA, Hadders-Algra M. Development of postural control in cerebral palsy and cystic periventricular leukomalacia in infancy. Res Dev Disabil, 2018, 78: 66-77.
  • Hielkema T, Hamer EG, Boxum AG, La Bastide-van Gemert S, Dirks T, Reinders-Messelink HA, Maathuis CGB, Verheijden J, L2M 0-2 Study Group, Geertzen JHB, Hadders-Algra M. LEARN2MOVE 0-2 years, an early intervention trial for infants at very high risk of cerebral palsy: neuromotor, cognitive and behavioral outcome. Disabil Rehabil, accepted for publication.
  • Hielkema T, Hamer EG, Boxum AG, La Bastide-van Gemert S, Dirks T, Reinders-Messelink HA, Maathuis CGB, Verheijden J, L2M 0-2 Study Group, Geertzen JHB, Hadders-Algra M. LEARN2MOVE 0-2 years, an early intervention trial for infants at very high risk of cerebral palsy: family outcome and infant's functional outcome. Disabil Rehabil, accepted for publication.

Sponsors

Adriaanstichting

Johanna Kinderfonds

Nederlandse Vereniging van Revalidatieartsen

Phelps Stichting

Revalidatiefonds

Revalidatie Nederland

Stichting Rotterdams Kinderrevalidatie Fonds

ZonMW

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