Trial reportBMC pediatrics2016
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.
Trial report in BMC pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Small-step Program for Development of New Treatment Principles for Children With Cerebral Palsy and Other Neurodevelopmental Disorders
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Parent-mediated communication interventions for improving the communication skills of preschool children with non-progressive motor disorders.The Cochrane database of systematic reviews · 2018Pooled it
- The Small Step Early Intervention Program for Infants at High Risk of Cerebral Palsy: A Single-Subject Research Design Study.Journal of clinical medicine · 2024Article
- Factors influencing caregiver buy-in to early intervention physical therapy.Journal of pediatric rehabilitation medicine · 2024Article
- Engaging the Lower Extremity via Active Therapy Early (ELEVATE) Is Feasible and May Improve Gross Motor Function in Children with Spastic Bilateral Cerebral Palsy: A Case Series.Physiotherapy Canada. Physiotherapie Canada · 2023Article
- Parental Coping, Representations, and Interactions with Their Infants at High Risk of Cerebral Palsy.Journal of clinical medicine · 2022Article
- Parental engagement in early intervention for infants with cerebral palsy-A realist synthesis.Child: care, health and development · 2022Review
- Do Infants at Risk of Developing Cerebral Palsy or Other Neurodevelopmental Disorders Learn What They Practice?Journal of clinical medicine · 2020Article
- Efficacy of the Small Step Program in a Randomized Controlled Trial for Infants under 12 Months Old at Risk of Cerebral Palsy (CP) and Other Neurological Disorders.Journal of clinical medicine · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
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. DISCUSSION: 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.
trial registrationClinicalTrials.gov Identifier NCT02166801 . Registered June 12, 2014.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.