Physiotherapy-assisted overground exoskeleton use: mixed methods feasibility study protocol quantifying the user experience, as well as functional, neural, and muscular outcomes in children with mobility impairments.

Background: Early phase research suggests that physiotherapy paired with use of robotic walking aids provides a novel opportunity for children with severe mobility challenges to experience active walking. The Trexo Plus is a pediatric lower limb exoskeleton mounted on a wheeled walker frame, and is adjustable to fit a child's positional and gait requirements. It guides and powers the child's leg movements in a way that is individualized to their movement potential and upright support needs, and can provide progressive challenges for walking within a physiotherapy-based motor learning treatment paradigm. Methods: This protocol outlines a single group mixed-methods study that assesses the feasibility of physiotherapy-assisted overground Trexo use in school and outpatient settings during a 6-week physiotherapy block. Children ages 3-6 years (n = 10; cerebral palsy or related disorder, Gross Motor Function Classification System level IV) will be recruited by circle of care invitations to participate. Study indicators/outcomes will focus on evaluation of: (i) clinical feasibility, safety, and acceptability of intervention; (ii) pre-post intervention motor/functional outcomes; (iii) pre-post intervention brain structure characterization and resting state brain connectivity; (iv) muscle activity characterization during Trexo-assisted gait and natural assisted gait; (v) heart rate during Trexo-assisted gait and natural assisted gait; and (vi) user experience and perceptions of physiotherapists, children, and parents. Discussion: This will be the first study to investigate feasibility indicators, outcomes, and experiences of Trexo-based physiotherapy in a school and outpatient context with children who have mobility challenges. It will explore the possibility of experience-dependent neuroplasticity in the context of gait rehabilitation, as well as associated functional and muscular outcomes. Finally, the study will address important questions about clinical utility and future adoption of the device from the physiotherapists' perspective, comfort and engagement from the children's perspective, and the impressions of parents about the value of introducing this technology as an early intervention. Clinical trial registration: https://clinicaltrials.gov, identifier NCT05463211.

Gross Motor Family Report: Refinement and evaluation of psychometric properties.

AIM: To refine the Gross Motor Family Report (GM-FR) using parents' input and to evaluate its psychometric properties. METHOD: In this measurement study, 12 parents of children and adolescents with cerebral palsy (CP), aged 2 to 18 years, classified in all levels of the Gross Motor Function Classification System (GMFCS), were interviewed about their experience completing the GM-FR (content validity). Parents' feedback was used to refine the measure which was then completed by 146 families to evaluate internal consistency, and discriminative and concurrent validity. Forty-six parents completed the GM-FR again, 7 to 30 days later, to evaluate test-retest reliability. RESULTS: GM-FR scoring, pictures, descriptions, and the total number of items were revised based on parents' feedback. The GM-FR version 2.0 demonstrated high internal consistency (Cronbach's α = 0.99), no floor/ceiling effects, and excellent test-retest reliability (intraclass correlation coefficient = 0.99). GM-FR scores discriminated between GMFCS levels (p < 0.05) and were strongly negatively correlated with GMFCS level (r = -0.92; p < 0.001). GM-FR scores correlated positively and strongly with the Gross Motor Function Measure-66 (r = 0.94; p < 0.001) and the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test mobility domain (r = 0.93; p < 0.001). INTERPRETATION: Active participation of families in the GM-FR's development facilitated creation of a family-friendly instrument. This study provides strong evidence of reliability and validity to support GM-FR use in clinical practice and research for assessing gross motor performance of children and adolescents with CP.

Evaluating the impact of movement tracking feedback on engagement with home exercise programmes of children with cerebral palsy using a new therapy app: a protocol for a mixed-methods single-case experimental design with alternating treatments.

INTRODUCTION: Children with cerebral palsy (CP) are prescribed home exercise programmes (HEPs) to increase the frequency of movement practice, yet adherence to HEPs can be low. This paper outlines the protocol for a single-case experimental design (SCED) with alternating treatments, using a new home therapy exercise application, Bootle Boot Camp (BBCamp), offered with and without movement tracking feedback. This study will explore the impact of feedback on engagement, movement quality, lower limb function and family experiences to help understand how technology-supported HEPs should be translated and the added value, if any, of movement tracking technology. METHODS AND ANALYSIS: In this explanatory sequential mixed-methods study using a SCED, 16 children with CP (aged 6-12 years, Gross Motor Function Classification System levels I-II) will set lower limb goals and be prescribed an individualised HEP by their physiotherapist to complete using BBCamp on their home television equipped with a three-dimensional camera-computer system. Children will complete four weekly exercise sessions over 6 weeks. Children will be randomised to 1 of 16 alternating treatment schedules where BBCamp will provide or withhold feedback during the first 4 weeks. The version of BBCamp that results in the most therapeutic benefit will be continued for 2 final weeks. Goals will be re-evaluated and families interviewed. The primary outcome is adherence (proportion of prescribed exercise repetitions attempted) as a measure of behavioural engagement. Secondary outcomes are affective and cognitive engagement (smiley face ratings), exercise fidelity, lower limb function, goal achievement and participant experiences. SCED data will be analysed using visual and statistical methods. Quantitative and qualitative data will be integrated using joint displays. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Research Ethics Boards at Bloorview Research Institute and the University of Toronto. Results will be distributed through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT05998239; pre-results.

Quick, Effective Screening Tasks Identify Children With Medical Conditions or Disabilities Needing Physical Literacy Support.

PURPOSE: This study evaluated screening tasks able to identify children with medical conditions or disabilities who may benefit from physical literacy. METHOD: Children completed ≤20 screening tasks during their clinic visit and then the Canadian Assessment of Physical Literacy (2nd edition) at a separate visit. Total Canadian Assessment of Physical Literacy scores <30th percentile were categorized as potentially needing physical literacy support. Receiver operator characteristic curves identified assessment cut points with 80% sensitivity and 40% specificity relative to total physical literacy scores. RESULTS: 223 children (97 girls; 10.1 [2.6] y) participated. Physical activity adequacy, predilection, and physical competence achieved ≥80% sensitivity and ≥40% specificity in both data sets. Adequacy ≤ 6.5 had 86% to 100% sensitivity and 48% to 49% specificity. Daily screen time >4.9 hours combined with Adequacy ≤6.15 had 88% to 10% sensitivity and 53% to 56% specificity. CONCLUSIONS: Activity adequacy, alone or with screen time, most effectively identified children likely to benefit from physical literacy support. Adequacy and screen time questionnaires are suitable for clinical use. Similar results regardless of diagnosis suggest physical competence deficits are not primary determinants of active lifestyles. Research to enhance screening specificity is required.