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2.
Zoology (Jena) ; 158: 126093, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37149943

RESUMEN

Animals in the wild continually experience changes in environmental and social conditions, which they respond to with behavioural, physiological and morphological adaptations related to individual phenotypic quality. During unfavourable environmental conditions, reproduction can be traded-off against self-maintenance, mediated through changes in reproductive hormone levels. Using the European badger (Meles meles) as a model species, we examine how testosterone in males and oestrogens in females respond to marked deviations in weather from the long-term mean (rainfall and temperature, where badger earthworm food supply is weather dependent), and to social factors (number of adult males and females per social group and total adults in the population), in relation to age, weight and head-body length. Across seasons, testosterone levels correlated postively with body weight and rainfall variability, whereas oestrone correlated positively with population density, but negatively with temperature variability. Restricting analyses to the mating season (spring), heavier males had higher testosterone levels and longer females had higher oestradiol levels. Spring oestrone levels were lower when temperatures were above normal. That we see these effects for this generally adaptive species with a broad bioclimatic niche serves to highlight that climatic effects (especially with the threat of anthropogenic climate change) on reproductive physiology warrant careful attention in a conservation context.


Asunto(s)
Estrona , Mustelidae , Femenino , Masculino , Animales , Factores Sociales , Tiempo (Meteorología) , Estaciones del Año , Testosterona , Mustelidae/anatomía & histología
3.
J Geophys Res Planets ; 128(1): e2022JE007480, 2023 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37034458

RESUMEN

The pressure sensors on Mars rover Perseverance measure the pressure field in the Jezero crater on regular hourly basis starting in sol 15 after landing. The present study extends up to sol 460 encompassing the range of solar longitudes from L s  âˆ¼ 13°-241° (Martian Year (MY) 36). The data show the changing daily pressure cycle, the sol-to-sol seasonal evolution of the mean pressure field driven by the CO2 sublimation and deposition cycle at the poles, the characterization of up to six components of the atmospheric tides and their relationship to dust content in the atmosphere. They also show the presence of wave disturbances with periods 2-5 sols, exploring their baroclinic nature, short period oscillations (mainly at night-time) in the range 8-24 min that we interpret as internal gravity waves, transient pressure drops with duration ∼1-150 s produced by vortices, and rapid turbulent fluctuations. We also analyze the effects on pressure measurements produced by a regional dust storm over Jezero at L s  âˆ¼ 155°.

4.
Phys Rev Lett ; 130(7): 077102, 2023 Feb 17.
Artículo en Inglés | MEDLINE | ID: mdl-36867816

RESUMEN

We consider short-range Ising spin glasses in equilibrium at infinite system size, and prove that, for fixed bond realization and a given Gibbs state drawn from a suitable metastate, each translation and locally invariant function (for example, self-overlaps) of a single pure state in the decomposition of the Gibbs state takes the same value for all the pure states in that Gibbs state. We describe several significant applications to spin glasses.

5.
Nat Commun ; 13(1): 7505, 2022 12 13.
Artículo en Inglés | MEDLINE | ID: mdl-36513637

RESUMEN

Dust devils (convective vortices loaded with dust) are common at the surface of Mars, particularly at Jezero crater, the landing site of the Perseverance rover. They are indicators of atmospheric turbulence and are an important lifting mechanism for the Martian dust cycle. Improving our understanding of dust lifting and atmospheric transport is key for accurate simulation of the dust cycle and for the prediction of dust storms, in addition to being important for future space exploration as grain impacts are implicated in the degradation of hardware on the surface of Mars. Here we describe the sound of a Martian dust devil as recorded by the SuperCam instrument on the Perseverance rover. The dust devil encounter was also simultaneously imaged by the Perseverance rover's Navigation Camera and observed by several sensors in the Mars Environmental Dynamics Analyzer instrument. Combining these unique multi-sensorial data with modelling, we show that the dust devil was around 25 m large, at least 118 m tall, and passed directly over the rover travelling at approximately 5 m s-1. Acoustic signals of grain impacts recorded during the vortex encounter provide quantitative information about the number density of particles in the vortex. The sound of a Martian dust devil was inaccessible until SuperCam microphone recordings. This chance dust devil encounter demonstrates the potential of acoustic data for resolving the rapid wind structure of the Martian atmosphere and for directly quantifying wind-blown grain fluxes on Mars.


Asunto(s)
Medio Ambiente Extraterrestre , Marte , Polvo/análisis , Viento , Atmósfera
6.
Geophys Res Lett ; 49(17): e2022GL100126, 2022 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-36245893

RESUMEN

Rovers and landers on Mars have experienced local, regional, and planetary-scale dust storms. However, in situ documentation of active lifting within storms has remained elusive. Over 5-11 January 2022 (LS 153°-156°), a dust storm passed over the Perseverance rover site. Peak visible optical depth was ∼2, and visibility across the crater was briefly reduced. Pressure amplitudes and temperatures responded to the storm. Winds up to 20 m s-1 rotated around the site before the wind sensor was damaged. The rover imaged 21 dust-lifting events-gusts and dust devils-in one 25-min period, and at least three events mobilized sediment near the rover. Rover tracks and drill cuttings were extensively modified, and debris was moved onto the rover deck. Migration of small ripples was seen, but there was no large-scale change in undisturbed areas. This work presents an overview of observations and initial results from the study of the storm.

7.
Trials ; 23(1): 795, 2022 Sep 21.
Artículo en Inglés | MEDLINE | ID: mdl-36131291

RESUMEN

BACKGROUND: Pregnancies affected by gestational diabetes mellitus (GDM) are associated with an increased risk of adverse maternal and foetal outcomes. Current treatments for GDM involve initial medical nutritional therapy (MNT) and exercise and pharmacotherapy in those with persistent hyperglycaemia. Insulin is considered first-line pharmacotherapy but is associated with hypoglycaemia, excessive gestational weight gain (GWG) and an increased caesarean delivery rate. Metformin is safe in selected groups of women with GDM but is not first-line therapy in many guidelines due to a lack of long-term data on efficacy. The EMERGE trial will evaluate the effectiveness of early initiation of metformin in GDM. METHODS: EMERGE is a phase III, superiority, parallel, 1:1 randomised, double-blind, placebo-controlled trial comparing the effectiveness of metformin versus placebo initiated by 28 weeks (+6 days) plus usual care. Women aged 18-50 years will be recruited. Women with established diabetes, multiple pregnancies, known major congenital malformation or small for gestational age (<10th centile), intolerance or contraindication to the use of metformin, shock or sepsis, current gestational hypertension or pre-eclampsia, significant gastrointestinal problems, congestive heart failure, severe mental illness or galactose intolerance are excluded. INTERVENTION: Immediate introduction of metformin or placebo in addition to MNT and usual care. Metformin is initiated at 500mg/day and titrated to a maximum dose of 2500mg over 10 days. Women are followed up at 4 and 12 weeks post-partum to assess maternal and neonatal outcomes. The composite primary outcome measure is initiation of insulin or fasting blood glucose ≥ 5.1 mmol/L at gestational weeks 32 or 38. The secondary outcomes are the time to insulin initiation and insulin dose required; maternal morbidity at delivery; mode and time of delivery; postpartum glucose status; insulin resistance; postpartum body mass index (BMI); gestational weight gain; infant birth weight; neonatal height and head circumference at delivery; neonatal morbidities (neonatal care unit admission, respiratory distress, jaundice, congenital anomalies, Apgar score); neonatal hypoglycaemia; cost-effectiveness; treatment acceptability and quality of life determined by the EQ5D-5L scale. DISCUSSION: The EMERGE trial will determine the effectiveness and safety of early and routine use of metformin in GDM. TRIAL REGISTRATION: EudraCT Number 2016-001644-19l; NCT NCT02980276 . Registered on 6 June 2017.


Asunto(s)
Diabetes Gestacional , Ganancia de Peso Gestacional , Hipoglucemia , Metformina , Glucemia , Ensayos Clínicos Fase III como Asunto , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/tratamiento farmacológico , Femenino , Galactosa , Humanos , Hipoglucemia/inducido químicamente , Recién Nacido , Insulina/efectos adversos , Metformina/efectos adversos , Embarazo , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Aumento de Peso
8.
J Geophys Res Planets ; 127(5): e2022JE007190, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-35865505

RESUMEN

Observations of the South Polar Residual Cap suggest a possible erosion of the cap, leading to an increase of the global mass of the atmosphere. We test this assumption by making the first comparison between Viking 1 and InSight surface pressure data, which were recorded 40 years apart. Such a comparison also allows us to determine changes in the dynamics of the seasonal ice caps between these two periods. To do so, we first had to recalibrate the InSight pressure data because of their unexpected sensitivity to the sensor temperature. Then, we had to design a procedure to compare distant pressure measurements. We propose two surface pressure interpolation methods at the local and global scale to do the comparison. The comparison of Viking and InSight seasonal surface pressure variations does not show changes larger than ±8 Pa in the CO2 cycle. Such conclusions are supported by an analysis of Mars Science Laboratory (MSL) pressure data. Further comparisons with images of the south seasonal cap taken by the Viking 2 orbiter and MARCI camera do not display significant changes in the dynamics of this cap over a 40 year period. Only a possible larger extension of the North Cap after the global storm of MY 34 is observed, but the physical mechanisms behind this anomaly are not well determined. Finally, the first comparison of MSL and InSight pressure data suggests a pressure deficit at Gale crater during southern summer, possibly resulting from a large presence of dust suspended within the crater.

10.
Phys Rev E ; 105(4-1): 044132, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35590620

RESUMEN

We propose an approach toward understanding the spin glass phase at zero and low temperature by studying the stability of a spin glass ground state against perturbations of a single coupling. After reviewing the concepts of flexibility, critical droplet, and related quantities for both finite- and infinite-volume ground states, we study some of their properties and review three models in which these quantities are partially or fully understood. We also review a recent result showing the connection between our approach and that of disorder chaos. We then view four proposed scenarios for the low-temperature spin glass phase-replica symmetry breaking, scaling-droplet, TNT, and chaotic pairs-through the lens of the predictions of each scenario for the lowest-energy large-lengthscale excitations above the ground state. Using a new concept called σ-criticality, which quantifies the sensitivity of ground states to single-bond coupling variations, we show that each of these four pictures can be identified with different critical droplet geometries and energies. We also investigate necessary and sufficient conditions for the existence of multiple incongruent ground states.

11.
Diabetes Res Clin Pract ; 188: 109879, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35483543

RESUMEN

AIMS: Patient-reported outcomes (PROs) are reports of the patient's health status that come directly from the patient without interpretation by the clinician or anyone else. They are increasingly used in randomised controlled trials (RCTs). In this systematic review we identified RCTs conducted in women with diabetes in pregnancy which included PROs in their primary or secondary outcomes. We then evaluated the quality of PRO reporting against an internationally accepted reporting framework (Consolidated Standards of Reporting Trials (CONSORT-PRO) guidelines). METHODS: We searched online databases for studies published 2013-2021 using a combination of keywords. Two authors reviewed all abstracts independently. Data on study characteristics and the quality of PRO reporting were extracted from relevant studies. We conducted a multiple regression analysis to identify factors associated with high quality reporting. RESULTS: We identified 7122 citations. Thirty-five articles were included for review. Only 17% of RCTs included a PRO as a primary or secondary outcome. Out of a maximum score of 100 the median score was 46, indicating sub-optimal reporting. A multiple regression analysis did not reveal any factors associated with high quality reporting. CONCLUSIONS: Researchers should be mindful of the importance of PRO inclusion and reporting and include reliable PROs in trials.


Asunto(s)
Diabetes Mellitus , Medición de Resultados Informados por el Paciente , Diabetes Mellitus/terapia , Femenino , Estado de Salud , Humanos , Embarazo
12.
Nature ; 605(7911): 653-658, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35364602

RESUMEN

Before the Perseverance rover landing, the acoustic environment of Mars was unknown. Models predicted that: (1) atmospheric turbulence changes at centimetre scales or smaller at the point where molecular viscosity converts kinetic energy into heat1, (2) the speed of sound varies at the surface with frequency2,3 and (3) high-frequency waves are strongly attenuated with distance in CO2 (refs. 2-4). However, theoretical models were uncertain because of a lack of experimental data at low pressure and the difficulty to characterize turbulence or attenuation in a closed environment. Here, using Perseverance microphone recordings, we present the first characterization of the acoustic environment on Mars and pressure fluctuations in the audible range and beyond, from 20 Hz to 50 kHz. We find that atmospheric sounds extend measurements of pressure variations down to 1,000 times smaller scales than ever observed before, showing a dissipative regime extending over five orders of magnitude in energy. Using point sources of sound (Ingenuity rotorcraft, laser-induced sparks), we highlight two distinct values for the speed of sound that are about 10 m s-1 apart below and above 240 Hz, a unique characteristic of low-pressure CO2-dominated atmosphere. We also provide the acoustic attenuation with distance above 2 kHz, allowing us to explain the large contribution of the CO2 vibrational relaxation in the audible range. These results establish a ground truth for the modelling of acoustic processes, which is critical for studies in atmospheres such as those of Mars and Venus.

13.
J Geophys Res Planets ; 127(12): e2022JE007523, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37033152

RESUMEN

Wind speeds measured by the Mars 2020 Perseverance rover in Jezero crater were fitted as a Weibull distribution. InSight wind data acquired in Elysium Planitia were also used to contextualize observations. Jezero winds were found to be much calmer on average than in previous landing sites, despite the intense aeolian activity observed. However, a great influence of turbulence and wave activity was observed in the wind speed variations, thus driving the probability of reaching the highest wind speeds at Jezero, instead of sustained winds driven by local, regional, or large-scale circulation. The power spectral density of wind speed fluctuations follows a power-law, whose slope deviates depending on the time of day from that predicted considering homogeneous and isotropic turbulence. Daytime wave activity is related to convection cells and smaller eddies in the boundary layer, advected over the crater. The signature of convection cells was also found during dust storm conditions, when prevailing winds were consistent with a tidal drive. Nighttime fluctuations were also intense, suggesting strong mechanical turbulence. Convective vortices were usually involved in rapid wind fluctuations and extreme winds, with variations peaking at 9.2 times the background winds. Transient high wind events by vortex-passages, turbulence, and wave activity could be driving aeolian activity at Jezero. We report the detection of a strong dust cloud of 0.75-1.5 km in length passing over the rover. The observed aeolian activity had major implications for instrumentation, with the wind sensor suffering damage throughout the mission, probably due to flying debris advected by winds.

14.
J Geophys Res Planets ; 127(12): e2022JE007605, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37033154

RESUMEN

Martian atmospheric dust is a major driver of weather, with feedback between atmospheric dust distribution, circulation changes from radiative heating and cooling driven by this dust, and winds that mobilize surface dust and distribute it in the atmosphere. Wind-driven mobilization of surface dust is a poorly understood process due to significant uncertainty about minimum wind stress and whether the saltation of sand particles is required. This study utilizes video of six Ingenuity helicopter flights to measure dust lifting during helicopter ascents, traverses, and descents. Dust mobilization persisted on takeoff until the helicopter exceeded 3 m altitude, with dust advecting at 4-6 m/s. During landing, dust mobilization initiated at 2.3-3.6 m altitude. Extensive dust mobilization occurred during traverses at 5.1-5.7 m altitude. Dust mobilization threshold friction velocity of rotor-induced winds during landing is modeled at 0.4-0.6 m/s (factor of two uncertainty in this estimate), with higher winds required when the helicopter was over undisturbed terrain. Modeling dust mobilization from >5 m cruising altitude indicates mobilization by 0.3 m/s winds, suggesting nonsaltation mechanisms such as mobilization and destruction of dust aggregates. No dependence on background winds was seen for the initiation of dust lifting but one case of takeoff in 7 m/s winds created a track of darkened terrain downwind of the helicopter, which may have been a saltation cluster. When the helicopter was cruising at 5-6 m altitude, recirculation was seen in the dust clouds.

15.
BJOG ; 128(11): 1855-1868, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34218508

RESUMEN

OBJECTIVE: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). DESIGN: A consensus developmental study. SETTING: International. POPULATION: Two hundred and five stakeholders completed the first round. METHODS: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. MAIN OUTCOME MEASURES: All outcomes were extracted from the literature. RESULTS: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. CONCLUSIONS: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. TWEETABLE ABSTRACT: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.


Asunto(s)
Diabetes Gestacional/terapia , Evaluación de Resultado en la Atención de Salud/normas , Atención Prenatal/normas , Consenso , Técnica Delphi , Femenino , Humanos , Cooperación Internacional , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto , Participación de los Interesados , Resultado del Tratamiento
16.
BJOG ; 128(12): 1894-1904, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34258852

RESUMEN

BACKGROUND: Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence. OBJECTIVES: To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. SEARCH STRATEGY: CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. SELECTION CRITERIA: Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. DATA COLLECTION AND ANALYSIS: Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. MAIN RESULTS: Sixty-seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1-46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). CONCLUSIONS: Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. REGISTRATION: The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). TWEETABLE ABSTRACT: Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy.


Asunto(s)
Resultado del Embarazo , Embarazo en Diabéticas/tratamiento farmacológico , Atención Prenatal/métodos , Automonitorización de la Glucosa Sanguínea , Femenino , Humanos , Hipoglucemiantes/uso terapéutico , Metformina/uso terapéutico , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
17.
Space Sci Rev ; 217(1): 20, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33583960

RESUMEN

Nine simulations are used to predict the meteorology and aeolian activity of the Mars 2020 landing site region. Predicted seasonal variations of pressure and surface and atmospheric temperature generally agree. Minimum and maximum pressure is predicted at Ls ∼ 145 ∘ and 250 ∘ , respectively. Maximum and minimum surface and atmospheric temperature are predicted at Ls ∼ 180 ∘ and 270 ∘ , respectively; i.e., are warmest at northern fall equinox not summer solstice. Daily pressure cycles vary more between simulations, possibly due to differences in atmospheric dust distributions. Jezero crater sits inside and close to the NW rim of the huge Isidis basin, whose daytime upslope (∼east-southeasterly) and nighttime downslope (∼northwesterly) winds are predicted to dominate except around summer solstice, when the global circulation produces more southerly wind directions. Wind predictions vary hugely, with annual maximum speeds varying from 11 to 19 ms - 1 and daily mean wind speeds peaking in the first half of summer for most simulations but in the second half of the year for two. Most simulations predict net annual sand transport toward the WNW, which is generally consistent with aeolian observations, and peak sand fluxes in the first half of summer, with the weakest fluxes around winter solstice due to opposition between the global circulation and daytime upslope winds. However, one simulation predicts transport toward the NW, while another predicts fluxes peaking later and transport toward the WSW. Vortex activity is predicted to peak in summer and dip around winter solstice, and to be greater than at InSight and much greater than in Gale crater. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11214-020-00788-2.

18.
Diabetes Res Clin Pract ; 173: 108685, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33548336

RESUMEN

AIMS: Pre-gestational diabetes mellitus (PGDM) is associated with adverse outcomes. We aimed to examine pregnancies affected by PGDM; report on these pregnancy outcomes and compare outcomes for patients with type 1 versus type 2 diabetes mellitus; compare our findings to published Irish and United Kingdom (UK) data and identify potential areas for improvement. METHODS: Between 2016 and 2018 information on 679 pregnancies from 415 women with type 1 Diabetes Mellitus and 244 women with type 2 diabetes was analysed. Data was collected on maternal characteristics; pregnancy preparation; glycaemic control; pregnancy related complications; foetal and maternal outcomes; unscheduled hospitalisations; congenital anomalies and perinatal deaths. RESULTS: Only 15.9% of women were adequately prepared for pregnancy. Significant deficits were identified in availability and attendance at pre-pregnancy clinic, use of folic acid, attaining appropriate glycaemic targets and appropriate retinal screening. The majority of pregnancies (n = 567, 83.5%) resulted in a live birth but the large number of infants born large for gestational age (LGA) (n = 280, 49.4%), born prematurely <37 weeks and requiring neonatal intensive care unit (NICU) admission continue to be significant issues. CONCLUSIONS: This retrospective cohort study identifies multiple targets for improvements in the provision of care to women with pre-gestational DM which are likely to translate into better pregnancy outcomes.


Asunto(s)
Resultado del Embarazo , Embarazo en Diabéticas/diagnóstico , Embarazo en Diabéticas/epidemiología , Adulto , Estudios de Cohortes , Femenino , Humanos , Irlanda , Embarazo , Estudios Retrospectivos
20.
BMC Neurol ; 20(1): 133, 2020 Apr 14.
Artículo en Inglés | MEDLINE | ID: mdl-32290815

RESUMEN

BACKGROUND: Cerebral palsy (CP) causes motor, cognitive and sensory impairment at different extents. Many recent rehabilitation developments (therapies) have focused solely on the upper extremities (UE), although the lower extremities (LE) are commonly affected. Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the UE and LE. It involves constant stimulation of the UE and LE, for several hours each day over a 2-week period. The effects of HABIT-ILE have never been evaluated in a large sample of young children. Furthermore, understanding of functional, neuroplastic and biomechanical changes in infants with CP is lacking. The aim of this study is to carry out a multi-center randomized controlled trial (RCT) to evaluate the effects of HABIT-ILE in pre-school children with unilateral CP on functional, neuroplastic and biomechanical parameters. METHODS: This multi-center, 3-country study will include 50 pre-school children with CP aged 1-4 years. The RCT will compare the effect of 50 h (two weeks) of HABIT-ILE versus usual motor activity, including regular rehabilitation. HABIT-ILE will be delivered in a day-camp setting, with structured activities and functional tasks that will be continuously progressed in terms of difficulty. Assessments will be performed at 3 intervals: baseline (T0), two weeks later and 3 months later. Primary outcomes will be the Assisting Hand Assessment; secondary outcomes include the Melbourne Assessment-2, executive function assessments, questionnaires ACTIVLIM-CP, Pediatric Evaluation of Disability Inventory, Young Children's Participation and Environment Measure, Measure of the Process of Care, Canadian Occupational Performance Measure, as well as neuroimaging and kinematics measures. DISCUSSION: We expect that HABIT-ILE will induce functional, neuroplastic and biomechanical changes as a result of the intense, activity-based rehabilitation process and these changes will impact the whole developmental curve of each child, improving functional ability, activity and participation in the short-, mid- and long-term. Name of the registry: Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy (EarlyHABIT-ILE). TRIAL REGISTRATION: Trial registration number: NCT04020354-Registration date on the International Clinical Trials Registry Platform (ICTRP): November 20th, 2018; Registration date on NIH Clinical Trials Registry: July 16th, 2019.


Asunto(s)
Parálisis Cerebral/terapia , Modalidades de Fisioterapia , Parálisis Cerebral/fisiopatología , Preescolar , Evaluación de la Discapacidad , Mano/fisiopatología , Humanos , Lactante , Extremidad Inferior/fisiopatología , Destreza Motora/fisiología , Plasticidad Neuronal , Prevención Secundaria , Encuestas y Cuestionarios , Extremidad Superior/fisiopatología
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