Efficacy of the small step program in a randomised controlled trial for infants below age 12 months with clinical signs of CP; a study protocol

BMC Pediatrics

Study Protocol

Kristina Löwing¹  Kristina Tedroff¹  Hans Forssberg¹  Lena Sjöstrand¹  Linda Holmström¹  Ann-Louise Weiland¹  Ann-Christin Eliasson¹  Päivikki Aarne²  Cecilia Nakeva von Mentzer³ 

[1] Department of Women’s and Children’s Health, Karolinska Institutet, 171 76, Stockholm, Sweden;Division of Speech and Language Pathology, Department of CLINTEC, Karolinska Institutet, Stockholm, Sweden;Department of Speech and Language Pathology, Karolinska University Hospital, Stockholm, Sweden;Unit for Speech Language Pathology, Department of Neuroscience, Uppsala University, Uppsala, Sweden;

关键词: Cerebral palsy;    Infant;    Early intervention;    Fine motor function;    Gross motor function;    Communication;   

DOI  :  10.1186/s12887-016-0711-x

 received in 2015-12-24, accepted in 2016-10-18,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundChildren with cerebral palsy (CP) have life-long motor disorders, and they are typically subjected to extensive treatment throughout their childhood. Despite this, there is a lack of evidence supporting the effectiveness of early interventions aiming at improving motor function, activity, and participation in daily life. The study will evaluate the effectiveness of the newly developed Small Step Program, which is introduced to children at risk of developing CP during their first year of life. The intervention is based upon theories of early learning-induced brain plasticity and comprises important components of evidence-based intervention approaches used with older children with CP.Method and designA two-group randomised control trial will be conducted. Invited infants at risk of developing CP due to a neonatal event affecting the brain will be randomised to either the Small Step Program or to usual care. They will be recruited from Astrid Lindgren Children’s Hospital at regular check-up and included at age 3–8 months. The Small Step Program was designed to provide individualized, goal directed, and intensive intervention focusing on hand use, mobility, and communication in the child’s own home environment and carried out by their parents who have been trained and coached by therapists. The primary endpoint will be approximately 35 weeks after the start of the intervention, and the secondary endpoint will be at 2 years of age. The primary outcome measure will be the Peabody Developmental Motor Scale (second edition). Secondary assessments will measure and describe the children’s general and specific development and brain pathology. In addition, the parents’ perspective of the program will be evaluated. General linear models will be used to compare outcomes between groups.DiscussionThis paper presents the background and rationale for developing the Small-Step Program and the design and protocol of a randomized controlled trial. The aim of the Small Step Program is to influence development by enabling children to function on a higher level than if not treated by the program and to evaluate whether the program will affect parent’s ability to cope with stress and anxiety related to having a child at risk of developing CP.Trial registrationClinicalTrials.gov Identifier NCT02166801. Registered June 12, 2014.

【 授权许可】

CC BY   
© The Author(s). 2016