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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

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 - COPCA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009794
Enrollment
68
Registered
2015-12-18
Start date
2016-02-29
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromotor disorder G80

Interventions

Group 1: 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 challen
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 ou

Sponsors

Zürcher Hochschule für Angewandte Wissenschaften, Departement Gesundheit, Institut für Physiotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 4 Months

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Switzerland

Contacts

Public ContactSchirin Akhbari Ziegler

Zürcher Hochschule für Angewandte Wissenschaften, Depatement Gesundheit, Institut für Physiotherapie

akhb@zhaw.ch+41 58 934 69 87

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026