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Sökning: WFRF:(Vitiello B)

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  • Smits, Anne, et al. (författare)
  • Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper.
  • 2021
  • Ingår i: British journal of clinical pharmacology. - 1365-2125.
  • Tidskriftsartikel (refereegranskat)abstract
    • Developmental pharmacology describes the impact of maturation on drug disposition (pharmacokinetics, PK) and drug effects (pharmacodynamics, PD) throughout the paediatric age range. This paper, written by a multidisciplinary group of experts, summarizes current knowledge, and provides suggestions to pharmaceutical companies, regulatory agencies and academicians on how to incorporate the latest knowledge regarding developmental pharmacology and innovative techniques into neonatal and paediatric drug development. Biological aspects of drug absorption, distribution, metabolism and excretion throughout development are summarized. Although this area made enormous progress during the last two decades, remaining knowledge gaps were identified. Minimal risk and burden designs allow for optimally informative but minimally invasive PK sampling, while concomitant profiling of drug metabolites may provide additional insight in the unique PK behaviour in children. Furthermore, developmental PD needs to be considered during drug development, which is illustrated by disease- and/or target organ-specific examples. Identifying and testing PD targets and effects in special populations, and application of age- and/or population-specific assessment tools are discussed. Drug development plans also need to incorporate innovative techniques such as preclinical models to study therapeutic strategies, and shift from sequential enrolment of subgroups, to more rational designs. To stimulate appropriate research plans, illustrations of specific PK/PD-related as well as drug safety-related challenges during drug development are provided. The suggestions made in this joint paper of the Innovative Medicines Initiative conect4children Expert group on Developmental Pharmacology and the European Society for Developmental, Perinatal and Paediatric Pharmacology, should facilitate all those involved in drug development.
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  • Crea, Simona, et al. (författare)
  • Time-Discrete Vibrotactile Feedback Contributes to Improved Gait Symmetry in Patients With Lower Limb Amputations : Case Series
  • 2017
  • Ingår i: Physical Therapy. - : AMER PHYSICAL THERAPY ASSOC. - 0031-9023 .- 1538-6724. ; 97:2, s. 198-207
  • Tidskriftsartikel (refereegranskat)abstract
    • Background. Reduced sensory feedback from lower leg prostheses results in harmful gait patterns and entails a significant cognitive burden because users have to visually monitor their locomotion. Objectives. The purpose of this study was to validate a sensory feedback device designed to help elderly patients with transfemoral amputation to improve their temporal gait symmetry after a training program aimed at associating the vibrotactile patterns with symmetrical walking. Design. This was a prospective quasi-experimental study including 3 elderly patients walking with lower leg prostheses. Methods. During training sessions, participants walked on a treadmill equipped with feedback device that controlled vibrotactile stimulators based on signals from a sensorized insole while provided with visual feedback about temporal gait symmetry. The vibrotactile stimulators delivered short-lasting, low-intensity vibrations synchronously with certain gait phase transitions. During pretraining and posttraining sessions, participants walked without visual feedback about gait symmetry under 4 conditions: with or without vibrotactile feedback while performing or not performing a secondary cognitive task. The primary outcome measure was temporal gait symmetry. Results. with <= 52 hours of training,the participants improved their temporal gait symmetry from 0.82 to 0.84 during the pretraining evaluation session to 0.98 to 1.02 during the follow-up session across all conditions. Following training, participants were able to maintain good temporal gait synmsetry, without any evidence of an increased cognitive burden. Limitations. The small sample size and short follow-up time do not allow straightforward extrapolations to larger populations or extended time periods. Conclusions. Low-cost, gait phase-specific vibrotactile feedback after training combined with visual feedback may improve the temporal gait synmsetry in patients with transfemoral amputation without representing an additional cognitive burden.
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  • Resultat 1-4 av 4

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