German Clinical Trials Register

Acronym/abbreviation of the study

COPCA

URL of the study

No Entry

Brief summary in lay language

Purpose of this study is the examination and comparison of two different intervention concepts in paediatric physical therapy for infants. Preterm infants with gestational age below 32 weeks are at high risk of movement disorders. These infants usually receive paediatric physiotherapy based on Neuro-Developmental Treatment. There is limited evidence on the effectiveness of traditional infant physiotherapy, such as Neuro-Developmental Treatment or Vojta therapy, and its benefit is therefore disputed. Family-centred interventions have a positive effect on cognitive development. The effect on motor development of these infants is inconsistent. In a first Dutch study, the novel programme “Coping with and Caring for Infants with Special Needs “, a programme which focuses on family-centred intervention, caregiver coaching, self-produced motor behaviour and trial-and-error experiences by means of play, was associated with a positive effect on motor development. Sixty-eight preterm infants will be randomly assigned to one of the two intervention groups. The intervention starts after discharge at home, when the infant is aged 35 weeks to 4 months corrected age and lasts for six months. The intervention is applied once a week for 45 minutes, or according to the paediatrician’s prescription. The family-centred intervention is carried out at the infant’s home. The infants who receive traditional infant physiotherapy are treated as usual, i.e. in an outpatient clinic, a specific paediatric physiotherapy setting or at the infant’s home. A follow-up assessment will be carried out at 18 months corrected age of the infants. Potential participants in the study are preterm infants with gestational age bellow 32 weeks at birth and with signs of movement disorders. The objective of this study is to identify differences, as a result of six months intervention with traditional ore family-centred therapy, in motor development of the preterm infants, in empowerment of the caregivers of these infants and in experience of the physiotherapy for there infant through the caregivers. Differences in these areas will be assessed after three moths of intervention, after six months of intervention and at the corrected age of 18 months of the infants. We presume that differences in motor development will be seen only at the corrected age of 18 months of the infants. Infants of the family-centred therapy group will show better competences in the ability to select the most appropriate movement in a certain situation. Caregivers of infants in the family-centred therapy group feel more empowered to deal with demands of an infant with special needs. Physiotherapy will be experienced as helpful of caregivers of both intervention groups. According to an amendment of the study protocol in June 016, following modifications has been executed: - Changes according to the inclusion- and exclusion criteria - Elongation of the recruitment time (12 months) The amendment has been authorized by the Ethics Committees KEK-ZH-Nr.2015-0229, EK NZ 2015-381, EK SG 15/153 (ProjectID PB_2016-01753) on June 29th 2016.

Brief summary in scientific language

Purpose of this study is the examination and comparison of two different intervention concepts in paediatric physical therapy for infants. Preterm infants with gestational age below 32 weeks are at high risk of neurodevelopmental disorders, such as cerebral palsy. These infants are in need of early physiotherapeutic intervention and usually receive paediatric physiotherapy based on Neuro-Developmental Treatment (NDT). However, there is limited evidence on the effectiveness of traditional infant physiotherapy, such as NDT or Vojta therapy, and its benefit is therefore disputed. Family-centred interventions have a positive effect on cognitive development. However, the effect on motor development of infants with neurodevelopmental disorders is inconsistent. In a first Dutch study, the novel programme “Coping with and Caring for Infants with Special Needs “ (COPCA), a programme which focuses on family-centred intervention, caregiver coaching, self-produced motor behaviour and trial-and-error experiences by means of play, was associated with a positive effect on motor development. 68 preterm infants will be recruited with the assistance of neonatal intensive care units in cantons Basle, Saint Gallen and Zurich. Infants will be randomly assigned to one of the two intervention groups. The intervention starts after discharge at home, when the infant is aged 35 weeks to 4 months corrected age and lasts for six months. The intervention is applied once a week for 45 minutes, or according to the paediatrician’s prescription. The COPCA intervention is carried out at the infant’s home. The infants who receive traditional infant physiotherapy are treated as usual, i.e. in an outpatient clinic, a specific paediatric physiotherapy setting or at the infant’s home. A follow-up assessment will be carried out at 18 months corrected age of the infants. Potential participants in the study are preterm infants with gestational age bellow 32 weeks at birth and with neurological dysfunction suggestive of neurodevelopmental disorders. The objective of this study is to identify differences, as a result of six months intervention with traditional ore family-centred therapy, in motor development of the preterm infants, in empowerment of the caregivers of these infants and in experience of the physiotherapy for there infant through the caregivers. Differences in these areas will be assessed after three moths of intervention, after six months of intervention and at the corrected age of 18 months of the infants. We presume that differences in motor development will be seen only at the corrected age of 18 months of the infants. Infants of the family-centred therapy group will show better competences in the ability to select the most appropriate movement in a certain situation. Caregivers of infants in the family-centred therapy group feel more empowered to deal with demands of an infant with special needs. Physiotherapy will be experienced as helpful of caregivers of both intervention groups.