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

Abstract

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.

Do Infants at Risk of Developing Cerebral Palsy or Other Neurodevelopmental Disorders Learn What They Practice?

“…The therapists who collected the data were not involved in the intervention and were blinded with respect to previous assessments of the children. Further details are presented elsewhere [ 12 ].…”

“…The rationale for dividing the intervention program into hand use, mobility, and communication was to help the families to optimize the training within each foci of training. Training was conducted daily and, as mentioned earlier, in the home, by the parents, who received weekly coaching and supervision from either physiotherapists or occupational therapists responsible for the specific foci (a more detailed description is provided in the study protocol) [ 12 ].…”

“…For the youngest children and/or those with the lowest ability, actions as simple as reaching out to touch their mother’s nose could be meaningful; meanwhile, as the child’s awareness and fine motor development improve, the task had to become more complex. With all children, it was necessary to continuously vary objects in order to maintain attention and to optimize the conditions for development (for a more detailed description of hand use, see [ 12 ].…”

“…The current investigation extends the findings of a recent Randomized Controlled Trial (RCT) [ 11 ] that evaluated the effects of the Small Step Program on young children. This program is based on principles of motor learning, including a combination of incorporated intervention elements to provide individualized, goal-directed, and self-initiated activity during an intensive period of training that addresses different foci (mobility, hand use, and communication) within specific time-frames, implemented in the child’s home environment by the their parents (who have been coached by therapists) [ 12 , 13 ]. Similar interventional elements have previously been suggested to be included in other early intervention programs [ 14 , 15 ].…”

Avaliação instrumentalizada do desenvolvimento infantil: nova realidade brasileira

“…This process is based on the knowledge about brain plasticity, which is vulnerable to environmental manipulations, with specific stimuli, opening the path for the treatment of neurological disorders, with the possibility of a favorable prognosis (1,2) . The earlier the diagnosis and initiation of essential stimulation, especially with family involvement to receive guidelines and training, the greater the ability of parents to deal with stress and anxiety related to having a child at risk for delay or already diagnosed with changes in development (3).…”