Reporting Completeness of Intensity-, Dose-, and Dosage-Related Items in Active Pediatric Upper Limb Neurorehabilitation Trials: A Systematic Review.

OBJECTIVE: To analyze the reporting completeness of the TIDieR items 8-12, in particular intensity, dose, and dosage, in active pediatric upper limb neurorehabilitation trials. DATA SOURCES: We searched PubMed Central, Scopus, CINAHL, OTseeker, and Web of Science for eligible publications. STUDY SELECTION: We included publications analyzing active pediatric upper limb neurorehabilitation interventions and assessed the reporting completeness of 11 items for each intervention and control group. DATA EXTRACTION: Two raters independently screened titles and abstracts and selected the publications using the RYYAN platform. We unblinded the results after the raters had completed their selection and resolved the disagreements by discussion. We used the same procedures to review the full texts. DATA SYNTHESIS: We included 52 randomized controlled trials with 65 intervention and 48 control groups. Authors did not report all 11 items in any of the study groups. The overall reporting completeness varied between 1% (intensity) to 95% (length of the intervention). The reporting completeness of the TIDieR items ranged from 2% (modifications) to 64% (when and how much). We found no significant differences in the reporting completeness between the intervention and control groups. CONCLUSIONS: Information essential for dose-response calculations is often missing in randomized controlled trials of pediatric upper limb neurorehabilitation interventions. Reporting completeness should be improved, and new measures to accurately quantify intensity should be discussed and developed.

A Tailorable Robotic Hand Orthosis to Support Children with Neurological Hand Impairments: a Case Study in a Child's Home.

Neurological disorders such as traumatic brain injuries (TBI) can lead to hand impairments in children, negatively impacting their quality of life. Fully wearable robotic hand orthoses (RHO) have been proposed to actively support children and promote the use of the impaired limb in daily life. Here we report a case study on the feasibility of using the pediatric RHO PEXO for assistance at home in a 13- year-old child with hand impairment after TBI. The size and functionalities of the RHO were first fully tailored to the child's needs. We trained the child and their parent on independently using the RHO before taking it home for a period of two weeks. The use of the RHO improved hand ability. Additionally, the tailoring and training benefited the unimanual capacity (Box and Block Test score +2 after tailoring) and bimanual performance (Assisting Hand Assessment score +4) of the child with PEXO. Further, it increased device acceptance by the child and the parent. The child used PEXO at home for 76 minutes distributed over three days during eating and drinking tasks. Personal and environmental factors caused the moderate use. No adverse events or safety-related issues occurred. This study highlights the value of tailoring an assistive RHO and, for the first time, demonstrates the feasibility of home use of a pediatric RHO by children with neurological hand impairments.

Defining, quantifying, and reporting intensity, dose, and dosage of neurorehabilitative interventions focusing on motor outcomes.

Introduction: Determining the minimal amount of therapy needed for positive neurorehabilitative outcomes is important for optimizing active treatment interventions to improve motor outcomes. However, there are various challenges when quantifying these relationships: first, several consensuses on the definition and usage of the terms intensity, dose, and dosage of motor interventions have been proposed, but there seems to be no agreement, and the terms are still used inconsistently. Second, randomized controlled trials frequently underreport items relevant to determining the intensity, dose, and dosage of the interventions. Third, there is no universal measure to quantify therapy intensity accurately. This "perspectives" paper aims to increase awareness of these topics among neurorehabilitation specialists. Defining quantifying and reporting: We searched the literature for definitions of intensity, dose, and dosage and adapted the ones we considered the most appropriate to fit the needs of neurorehabilitative interventions. Furthermore, we suggest refining the template for intervention description and replication (TIDieR) to enhance the reporting of randomized controlled trials. Finally, we performed a systematic literature search to provide a list of intensity measures and complemented these with some novel candidate measures. Discussion: The proposed definitions of intensity, dose, and dosage could improve the communication between neurorehabilitation specialists and the reporting of dose and dosage in interventional studies. Quantifying intensity is necessary to improve our understanding of the minimal intensity, dose, and dosage of therapy needed to improve motor outcomes in neurorehabilitation. We consider the lack of appropriate intensity measures a significant gap in knowledge requiring future research.

Obesity, blood pressure and retinal microvascular phenotype in a bi-ethnic cohort of young children.

BACKGROUND AND AIMS: Childhood obesity and high blood pressure (BP) are main determinants for cardiovascular disease development with regional and ethnic differences. Narrower arteriolar (CRAE) and wider venular (CRVE) retinal vessel diameters are sensitive markers of early vascular compromise in children. We aimed to compare retinal vessel diameters and investigate associations and odds ratios with body mass index (BMI) and BP in a multi-national/ethnic childhood study. METHODS: BMI, systolic (SBP) and diastolic BP (DBP) were screened in 929 black and white South African (SA) and 1171 Swiss children (aged 5-9 years). Retinal assessments were performed using a retinal vessel analyzer to determine CRAE and CRVE. RESULTS: Black SA children had wider CRVE compared to white SA and Swiss children (all p < 0.001). However, BMI or BP was not associated with CRVE in black SA children. Higher BMI and BP associated with narrower CRAE in all children, except for BMI in black SA children, in whom narrower CRAE was found for every unit increase in SBP (ß = -0.199 µm, p = 0.001) and DBP (ß = -0.312 µm, p < 0.001). Obesity (OR:1.38[1.01; 1.89]), hypertension (OR:1.90[1.53; 2.36]) and black ethnicity (OR:1.50[1.18; 1.92]) increased the likelihood for arteriolar narrowing. CONCLUSIONS: Black SA children presented with wider retinal venules compared to their white SA and Swiss peers, which was unexplained by conventional risk factors. The overall risk of arteriolar narrowing was driven by obesity, hypertension and ethnicity. Our findings indicate the importance to differentiate cardiovascular risk by microvascular phenotype in different populations and ethnicity early in life.