A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a child-oriented goal-setting approach in paediatric rehabilitation (the ENGAGE approach): a study protocol.

BACKGROUND: Child-oriented goal-setting in pediatric rehabilitation may improve child motivation, engagement in therapy, child outcomes related to therapy, and service delivery efficiency. The primary objective of this trial is to determine the effectiveness of a principles-driven, child-focused approach to goal-setting, Enhancing Child Engagement in Goal-Setting (ENGAGE), on pediatric rehabilitation outcomes compared to usual practice. The three secondary objectives are to 1) compare costs and secondary outcomes of the ENGAGE approach to usual practice, 2) determine the influence of child, parent and therapist characteristics on child engagement in therapy and rehabilitation outcomes, and 3) identify barriers and facilitators to the implementation of ENGAGE. METHODS: This research protocol describes a pragmatic, multi-site, cluster, effectiveness-implementation (hybrid type 1 design) randomized controlled trial. Therapists (n = 12 clusters of two therapists) at participating sites (n = 6) will be randomized to 1) the ENGAGE intervention group, or 2) usual care (control) using a computer-generated, permuted-block randomization sequence with site as a stratification variable designed by a statistician (RR). Each therapist will recruit four children 5-12 years old with neurodevelopmental conditions (n = 96), who will receive ENGAGE or usual care, according to therapist group allocation. ENGAGE therapists will be trained to use a 'toolbox' of evidence-driven, theory-informed principles to optimize child and parent motivation, engagement in the goal-setting process, and performance feedback strategies. Outcomes include goal performance (primary outcome), engagement in therapy, functional abilities, participation, and parent and child quality of life. Qualitative interviews with children, parents, ENGAGE therapists, and managers will explore challenges to implementation and potential mitigation strategies. Mixed effects multiple linear regression models will be developed for each outcome to assess group differences adjusted for clustering. A cost-effectiveness analysis will combine cost and a measure of effectiveness into an incremental cost-effectiveness ratio. Qualitative data on implementation will be analyzed inductively (thematic analysis) and deductively using established implementation science frameworks. DISCUSSION: This study will evaluate the effects of collaborative goal-setting in pediatric rehabilitation and inform effective implementation of child-focused goal-setting practices. TRIAL REGISTRATION: NCT05017363 (registered August 23, 2021 on ClinicalTrials.gov).

Parent experience with ankle-foot orthoses for their young children with cerebral palsy: a qualitative study.

PURPOSE: This study explored the experiences of parents of young children with cerebral palsy who used Ankle-Foot Orthoses (AFOs). MATERIALS AND METHODS: Parents of children with cerebral palsy (n = 11; age range 2-6 years) who used solid or hinged AFOs participated. Interpretive Description, a qualitative methodological approach focused on the application of findings to clinical practice, was used. Semi-structured interviews were conducted, and themes were developed using thematic analysis. RESULTS: Four themes described parent experience with their children's AFOs: 1) "Hear what I am saying": Collaborative decision-making with families, 2) "Is my child going to be excluded because of AFOs?": Parent and child adjustment was a journey, 3) AFOs created financial and practical challenges, 4) The perceived benefits of AFO use. CONCLUSIONS: Adjusting to AFOs was a challenging and time-consuming process for parents and children, which may have resulted in lower frequency and duration of use than anticipated by clinicians. Clinicians must be aware of the physical and psychosocial adjustment process as children and families adapt over time and work with families to ensure AFO use is optimized and individualized.

IMPLICATIONS FOR REHABILITATIONClinical practice will be enhanced by understanding  parent experience with their children's receipt and use of Ankle-Foot Orthoses (AFOs).Clinicians should work with families to establish and monitor individualized wear-time schedules that align with family routines.Information about AFOs, including appearance and alternative clothing requirements, should be provided to families in advance of receiving AFOs.

Ankle foot orthoses for young children with cerebral palsy: a scoping review.

AIM: To describe research on outcomes associated with early Ankle Foot Orthosis (AFO) use, AFO use patterns, and parent and clinician perspectives on AFO use among young children with cerebral palsy. METHOD: Arksey and O'Malley's five-stage method was used to conduct a scoping review. MEDLINE (Ovid), PubMed, CINAHL, Cochrane Database of Systematic Reviews, EMBASE, PEDro, Web of Science and Scopus were searched for studies evaluating AFO use with children under the age of six years. Descriptive information was extracted and outcomes categorized according to the International Classification of Functioning, Disability and Health (ICF). Quality assessments were conducted to evaluate methodological rigor. RESULTS: Nineteen articles were included in the review; 14 focused on body functions and structures, seven on activity level outcomes and no studies addressed participation outcomes. Evaluations of the effects of AFOs on gross motor skills other than gait were limited. Overall, the body of evidence is comprised of methodologically weak studies with common threats to validity including inadequate descriptions of study protocols, AFO construction, and comparison interventions. CONCLUSION: Research evaluating the effects of AFOs on age-appropriate, functional outcomes including transitional movements, floor mobility and participation in early childhood settings is needed to inform practice regarding early orthotic prescription. Implications for rehabilitationLack of rigorous evidence about the effects of AFOs in young children limits the ability of research to guide practice in pediatric rehabilitation.More rigorous research that evaluates a broader range of age-appropriate outcomes, including those focused on participation in meaningful activities, could further inform clinical practice.While clinicians often discuss expectations and goals with individual families, qualitative research that provides more insight into the experiences of families could guide AFO prescription and monitoring practices.