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.
Children 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.



A 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.



This 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.



ClinicalTrials.gov Identifier NCT02166801 . Registered June 12, 2014.
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden. ann-christin.eliasson@ki.se.
Ann-Christin
AC
Eliasson
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden.
Linda
L
Holmström
Division of Speech and Language Pathology, Department of CLINTEC, Karolinska Institutet, Stockholm, Sweden.|Department of Speech and Language Pathology, Karolinska University Hospital, Stockholm, Sweden.
Päivikki
P
Aarne
Unit for Speech Language Pathology, Department of Neuroscience, Uppsala University, Uppsala, Sweden.
Cecilia
C
Nakeva von Mentzer
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden.
Ann-Louise
AL
Weiland
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden.
Lena
L
Sjöstrand
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden.
Hans
H
Forssberg
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden.
Kristina
K
Tedroff
Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden.
Kristina
K
Löwing
D002547:Cerebral Palsy / Q000503:physiopathology / Q000523:psychology / Q000534:rehabilitation*; D002675:Child, Preschool; D002985:Clinical Protocols; D003142:Communication; D018479:Early Intervention, Educational / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D009048:Motor Skills; D009788:Occupational Therapy / Q000379:methods*; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
Cerebral palsy; Communication; Early intervention; Fine motor function; Gross motor function; Infant