Trial document




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  DRKS00009794

Trial Description

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Title

Effects of the Physiotherapeitic Intervention "Coping with and Caring for Infants with Special Needs - a Family-Centred Program" (COPCA) on the Development of Preterm Infants: a two-arm Randomized Trial

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Trial Acronym

COPCA

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URL of the Trial

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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.

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009794
  •   2015/12/18
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  •   yes
  •   Approved
  •   Leit EK KEK-ZH-Nr.2015_0229, Kantonale Ethikkommission Kanton Zürich Stampfenbachstrasse 121 CH-8090 Zürich
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G80 -  Cerebral palsy
  •   Neuromotor disorder
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Interventions/Observational Groups

  •   The therapeutic actions in COPCA consist of coaching the caregiver, informing the family on how they can stimulate the motor behaviour of the infant to the limit of its capability and challenging the infant to try to find its own motor solutions. COPCA promotes the infant’s active exploration and it’s learning by trial and error in varied conditions, allowing the infant to optimally probe its motor potential. COPCA emphasises that the caregiver acts as a decision-maker; the caregiver is an active participant in the process of early intervention. Therefore, COPCA is always provided at the infant’s home in the context of family life. The intervention will be carried out once a week for 45 minutes over a period of six months. The responsible paediatrician can prescribe more sessions if required.
  •   The physiotherapeutic actions of traditional infant physiotherapy (TIP) consist of training the caregiver handling and pressure techniques, provision of sensory experience and challenging the infant to move while handling techniques are integrated. This treatment usually takes place at an outpatient clinic or physiotherapy practice. Frequency, duration of treatment and series are the same as in the intervention group, i.e. one weekly treatment of 45 minutes for a period of 6 months.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is motor performance as measured by the Infant Motor profile (IMP) , a video-based assessment providing information on the child’s motor repertoire and its ability to adapt motor behaviour to the specifics of its situation. The instrument is designed for infants aged 3 -18 months. It will be carried out trough the infant’s paediatric physiotherapist. The IMP videos will be analysed by an assessor, masked with respect to the group allocation. The IMP has good reliability and validity. Specific measurement variables are: variation, adaptability, symmetry, fluency performance and total IMP Score. All subscales scores and the total IMP score are expressed as percentages, with a maximum score of 100%. Infants ≥ 3-months CA will be assessed at inclusion (T0), all infants during the intervention (after 3 months of intervention: T1), immediately after the intervention of 6 months (T2) and at the corrected age of 18 months (T3). The IMP is used for developmental evaluation in infants at high risk of developmental motor disorders. Children with prenatally acquired brain damage show more stereotypical motor behaviour with considerably less variation. During development, infants learn to select adaptive motor strategies out of their motor repertoire and to adapt their motor behaviour to the environment. Children with developmental motor disorders often have problems in selecting adaptive motor strategies.

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Secondary Outcome

Secondary child-related outcomes
Paediatric Evaluation Disability Inventory (PEDI), utilised to assess adaption to and participation in activities of daily life in children aged 6 months to 7 years, is a reliable and valid assessment. PEDI measures functional skills in the domains of self-care, mobility and social function, as well as caregiver assistance and modifications in complex activities. For this study, functional activities in the domain of mobility are the most meaningful. All scores of the PEDI are expressed as scale scores, with a maximum score of 100. Infants ≥ 6-months CA will be assessed during the intervention (after 3 months of intervention, T1), all infants immediately after the intervention of 6 months (T2) and at the corrected age of 18 months (T3). The PEDI has been adapted and validated for the German-speaking region by the Institute of Occupational Therapy at the Zurich University of Applied Sciences [27]. The PEDI is to be carried out by the paediatric physiotherapists in the context of a structured interview with the caregiver.

Secondary family-related outcomes
1.Family empowerment will be measured by the Family Empowerment Scale (FES). FES a questionnaire providing information on family-life, services for the child and the community of the family. It has sufficient reliability and validity. For this study, only the subscale “family” will be used in the German translation. FES will be assessed at inclusion (T0), during the intervention (after 3 months of intervention, T1), immediately after the intervention of 6 months (T2) and at the corrected age of 18 months (T3).
2.The Measurement of Process of Care (MPOC) is a parental questionnaire used to quantify the extent to which they experience family-centeredness in the care of their child. It has sufficient reliability and validity. MPOC will be assessed during the intervention (after 3 months of intervention, T1) and immediately after the intervention of 6 months (T2).

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/02/29
  •   68
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Weeks of pregnancy
  •   4   Months
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Additional Inclusion Criteria

Preterm infants with gestational age below 32 weeks at birth are recruited between age 35 weeks and 4 months corrected age (CA), based on the presence of one of the following characteristics:
•From a medical viewpoint, indication for paediatric physiotherapy
•Participation at the SwissNeoNet register

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Exclusion Criteria

•An additional severe congenital disorder, such as serious congenital heart disorder
•Known genetic syndrome, e.g. Down’s syndrome, exclusive club foot, plagiocephaly or cystic fibrosis
•Participation in the Epo-Repair Study
•Insufficient understanding of the German language by the caregiver

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Addresses

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    • Zürcher Hochschule für Angewandte Wissenschaften, Departement Gesundheit, Institut für Physiotherapie
    • Ms.  Msc  Schirin  Akhbari Ziegler 
    • Technikumstrasse 71
    • 8401  Winterthur
    • Switzerland
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    • KER-Zentrum, Ostschweizer Kinderspital St. Gallen
    • Mr.  Dr. med.  Oliver  Maier 
    • Claudiusstrasse 6
    • 9006  St. Gallen
    • Switzerland
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    • Zürcher Hochschule für Angewandte Wissenschaften, Depatement Gesundheit, Institut für Physiotherapie
    • Ms.  MSc  Schirin  Akhbari Ziegler 
    • Technikumstrasse71
    • 8401  Winterthur
    • Switzerland
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    • Zürcher Hochschule für Angewandte Wissenschaften, Depatement Gesundheit, Institut für Physiotherapie
    • Ms.  MSc  Schirin  Akhbari Ziegler 
    • Technikumstrasse71
    • 8401  Winterthur
    • Switzerland
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Sources of Monetary or Material Support

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    • Anna Müller Grocholsky-Stiftung
    • Freigutstrasse 27
    • 8002  Zürich
    • Switzerland
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    • Zürcher Hochschule für Angewandte Wissenschaften, Depatement Gesundheit, Institut für Physiotherapie
    • Ms.  MSc  Schirin  Akhbari Ziegler 
    • Technikumstrasse71
    • 8401  Winterthur
    • Switzerland
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    • Schweizerische Stiftung für das cerebral gelähmte Kind
    • Erlachstrasse 14
    • 3001  Bern
    • Switzerland
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    • Jubiläumsstiftung der Schweizerischen Mobiliar Genossenschaft
    • Bundesgasse 35
    • 30001  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2019/07/02
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* This entry means the parameter is not applicable or has not been set.