Guy Letellier

Aim: To assess the effects of pressure garment therapy (PGT) using a compressive Lycra sleeve on bimanual function in a large sample of children with unilateral cerebral palsy (CP). Methods: This multicentre, randomized, double‐blind placebo‐controlled clinical trial was conducted over 6 months. Children with unilateral CP were recruited across seven French rehabilitation centres between 2013 and 2020. Children were randomly assigned to receive either the active PGT sleeve or a placebo PGT sleeve. The primary outcome was bimanual function, assessed by the Assisting Hand Assessment (AHA) score at 6 months. Secondary outcomes included the Quality of Upper Extremity Skills Test score, quality of life, neuro‐orthopaedic examination results, and somatosensory evoked potentials (SEPs). Results: A total of 101 children were randomized (mean age [standard deviation] 7 years 1 month [1 year 6 months]). At 6 months, the AHA scores did not differ between groups (PGT 57.62 [0.97] vs placebo 57.63 [0.87]; mean difference − 0.01 AHA units [ p = 0.99]). There were no significant differences in any of the SEP parameters measuring upper arm nerve function between the two groups. For example, the mean difference in interside latency/amplitude for N9 SEPs was PGT 0.50 (0.09) versus placebo 0.50 (0.10); mean difference − 0.01 ( p = 0.96). Interpretation: These findings suggest that this form of PGT using a compressive dynamic Lycra sleeve (4 hours/day over 6 months at 15–25 mmHg) does not provide clinically meaningful improvements in bimanual function or neurophysiological outcomes in children with unilateral CP. This suggests limited clinical use for this intervention in routine rehabilitation practice.

1. Enteral nutrition (EN) is the preferred route of nutritional support for children who are unable to meet their nutritional requirements orally with a functioning gastrointestinal (GI) tract [1]....

Purpose: This study aimed to test a robotic supine gait training (RSGT) device's safety when treating children and adolescents with a variety of diagnoses, to ensure their safety and the standardization of clinical practices. Methods: This retrospective observational study included 280 patients who underwent one or more treatment sessions with a RSGT device (DPA Med ^® ) at the Nantes Regional Children's and Adolescent Health Care Center. These patients’ medical files, indexed in the digital medical file manager program, were examined in search of evidence of adverse events presumably associated with the treatment. The search also included when the adverse events took place, their severity, the required treatment, and the clinical outcomes. Results: From January 2, 2019, to June 1, 2021 (a 2.5-year period), no adverse events were logged, presumed, or definitively linked to the treatment, for any of the 280 patients included in this study (100% of the sample). Patients underwent an average of 5.71 (standard deviation = 7.06) treatment sessions, for a total of 1598 sessions during that period. Conclusion: No adverse events linked to RSGT were registered for the children and adolescents treated with the device in this preliminary study.

Aims: To test the long‐term efficacy, safety, and impact on quality of life (QoL) of an oral paediatric formulation of 320 μg/mL glycopyrronium in the 36‐week SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial.Method: In the initial 12‐week blinded period, 87 children with neurodisabilities and severe sialorrhoea were randomized to 320 μg/mL glycopyrronium versus placebo. In the subsequent 24‐week open‐label study extension, 74 children received 320 μg/mL glycopyrronium (37 continued glycopyrronium, 37 switched from placebo).Results: The open‐label study extension population included 39 males and 35 females. The median age was 10 years 2 months (quartile 1, quartile 3: 7 years 5 months, 14 years 7 months; range: 3 years 5 months–17 years 8 months). Over 36 weeks, continued 320 μg/mL glycopyrronium resulted in a median 39‐point reduction in Drooling Impact Scale (DIS) score from baseline (quartile 1, quartile 3: −51, −21; p < 0.001), with an 81.1% response rate (DIS improvement ≥ 13.6 points) and a 70.3% good response rate (≥ 28 points). Improvements in the impact of drooling on QoL seen in the blinded period were sustained with continued glycopyrronium. Treatment‐related adverse events occurred most frequently during titration (0–4 weeks: 40.9%; 5–20 weeks: 32.4% in those who switched). Constipation was the most common adverse event.Interpretation: Long‐term treatment with 320 μg/mL glycopyrronium resulted in significant sustained improvements in drooling and QoL, with fewer adverse events after initial titration and overall good tolerability.

Aim: To investigate the efficacy, safety, and impact on quality of life (QoL) of an oral formulation of 320 μg/mL glycopyrronium designed for children.Method: A double‐blind, placebo‐controlled SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial was conducted. Children (3–17 years) with neurodisabilities and severe sialorrhoea (modified Teachers Drooling Scale ≥6) were randomized to 320 μg/mL glycopyrronium or placebo, in addition to non‐pharmacological standard care.Results: Of 87 participants, 44 were aged 10 years or under and 43 had cerebral palsy. The primary endpoint, change in total Drooling Impact Scale (DIS) score from baseline to day 84, was significantly greater (improved) with 320 μg/mL glycopyrronium versus placebo (median [quartile 1, quartile 3] –29.5 [−44.5, 0] vs −1 [−16, 5]; p < 0.001), an effect also observed at day 28 (median − 25 vs −2; p < 0.01). Significant reduction in bibs/clothes used per day was seen with glycopyrronium versus placebo at day 84 (median − 2 vs 0; p < 0.01). Glycopyrronium significantly improved DIS items 9 and 10 related to the extent that drooling affects the child's and family's life (p ≤ 0.03). Adverse events were reported by 77.3% and 69.8% of children with glycopyrronium and placebo respectively; the most common treatment‐related adverse event was constipation (20.5% and 16.3%).Interpretation: The formulation of 320 μg/mL glycopyrronium significantly improved drooling and reduced its impact on QoL, with good tolerability in children with neurodisabilities.What this paper adds: The formulation of 320 μg/mL glycopyrronium significantly improved Drooling Impact Scale score versus placebo at day 84. The formulation reduced the impact of drooling on the child's and family's quality of life. There were no safety or tolerability concerns with this specific formulation.

Background: Upper limb impairment affects activity and participation in children with unilateral cerebral palsy (UCP). Pressure garment therapy (PGT) using compressive dynamic Lycra^® garments is an innovative intervention proposed for the management of cerebral palsy consequences. The PROPENSIX study aims to evaluate the efficacy of a therapy using a Lycra^® sleeve as compared to a placebo sleeve to improve bi-manual performance measured by the Assisting Hand Assessment (AHA) in children with unilateral cerebral palsy. Methods: The PROPENSIX trial is a multicenter, prospective, placebo-controlled, double-blinded, randomized study. One hundred children with UCP, aged from 5 to 10, are randomly assigned as soon as they are recruited in a 1:1 ratio to perform usual daily activities, especially activities involving bimanual performances, with Lycra^® sleeve or placebo sleeve during 6 months. The primary endpoint is the change in bimanual performance from inclusion to 6 months, evaluated by AHA. The secondary endpoints evaluate changes from inclusion to 6 months in other dimensions of the International Classification of Functioning (ICF), upper limb movement capacity assessed by Quality of Upper Extremity Skill Test (QUEST), and health-related quality of life evaluated by Pediatric Quality of Life Inventory 3.0 Cerebral Palsy Module (PedsQLTM 3.0 CP Module) and in body structures and functions domain assessed by neuro-orthopedic examination and somatosensory evoked potentials (SEP). Discussion: The PROPENSIX study is the largest randomized controlled trial (RCT) aiming to evaluate the efficacy of a PGT using compressive dynamic Lycra^® sleeve in UCP. Enhancement of children’s bimanual performance at the end of the 6 months wear of the Lycra^® sleeve should improve evidence regarding this type of treatment and expand discussion about their recommendation in clinical practice. Data from secondary outcomes assessments should bring interesting arguments to discuss the Lycra^® sleeve action on mobility, tonus, and sensory impairments in children with unilateral cerebral palsy. Trial registration: ClinicalTrials.gov NCT02086214. Retrospectively registered on March 13, 2014 Trial status: Study start data: December 2012. Recruitment status: completed. Primary completion date: April 2021. Estimated study completion date: December 2022. Protocol version 10 (date: February 2018).

Cet article est basé sur une étude socio-anthropologique menée auprès d’enfants et d’adolescents âgés de 6 à 15 ans vivant avec la dystrophie musculaire de Duchenne. La recherche ethnographique a été menée en France, entre 2019 et 2020, à partir d’observations de consultations pluridisciplinaires à l’hôpital et d’une série d’entretiens réalisés avec les jeunes patients, leurs parents et les soignants. L’étude a visé à examiner la négociation des actes de soin entre enfants et adultes lors des interactions sociales en consultations cliniques. Les résultats de la recherche mettent en évidence comment les jeunes patients s’opposent, résistent aux actes de soin et contribuent à façonner les manières dont les soignants agissent autour de leur corps. Malgré l’asymétrie des rapports d’âge et de santé avec les adultes, les enfants et les adolescents manifestent des compétences liées à la gestion de leur santé, leur bien-être, et à la participation au processus de décision.