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LEARN2MOVE 0 and 2 years, a randomized early intervention trial for infants at very high risk of cerebral palsy: family outcome and infant's functional outcome [with consumer summary]
Hielkema T, Boxum AG, Hamer EG, la Bastide-Van Gemert S, Dirks T, Reinders-Messelink HA, Maathuis CGB, Verheijden J, Geertzen JHB, Hadders-Algra M
Disability and Rehabilitation 2020;42(26):3762-3770
clinical trial
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE: To compare family and functional outcome in infants at very high risk of cerebral palsy, after receiving the family centred programme "coping with and caring for infants with special needs (COPCA)" or typical infant physiotherapy. MATERIALS AND METHODS: Forty-three infants at very high risk were included before 9 months corrected age and randomly assigned to one year COPCA (n = 23) or typical infant physiotherapy (n = 20). Family and infant outcome were assessed before and during the intervention. Physiotherapy intervention sessions were analysed quantitatively for process analysis. Outcome was evaluated with non-parametric tests and linear mixed-effect models. RESULTS: Between-group comparisons revealed no differences in family and infant outcomes. Within-group analysis showed that family's quality of life improved over time in the COPCA-group. Family empowerment was positively associated with intervention elements, including "caregiver coaching". CONCLUSIONS: One year of COPCA or typical infant physiotherapy resulted in similar family and functional outcomes. Yet, specific intervention elements, eg, coaching, may increase empowerment of families of very high risk infants and may influence quality of life, which emphasizes the importance of family centred services.

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