Dual-task versus single-task gait rehabilitation after stroke: the protocol of the cognitive-motor synergy multicenter, randomized, controlled superiority trial (SYNCOMOT).

BACKGROUND: Gait disorders and cognitive impairments are prime causes of disability and institutionalization after stroke. We hypothesized that relative to single-task gait rehabilitation (ST GR), cognitive-motor dual-task (DT) GR initiated at the subacute stage would be associated with greater improvements in ST and DT gait, balance, and cognitive performance, personal autonomy, disability, and quality of life in the short, medium and long terms after stroke. METHODS: This multicenter (n=12), two-arm, parallel-group, randomized (1:1), controlled clinical study is a superiority trial. With p<0.05, a power of 80%, and an expected loss to follow-up rate of 10%, the inclusion of 300 patients will be required to evidence a 0.1-m.s-1 gain in gait speed. Trial will include adult patients (18-90 years) in the subacute phase (0 to 6 months after a hemispheric stroke) and who are able to walk for 10 m (with or without a technical aid). Registered physiotherapists will deliver a standardized GR program (30 min three times a week, for 4 weeks). The GR program will comprise various DTs (phasic, executive function, praxis, memory, and spatial cognition tasks during gait) in the DT (experimental) group and gait exercises only in the ST (control) group. The primary outcome measure is gait speed 6 months after inclusion. The secondary outcomes are post-stroke impairments (National Institutes of Health Stroke Scale and the motor part of the Fugl-Meyer Assessment of the lower extremity), gait speed (10-m walking test), mobility and dynamic balance (timed up-and-go test), ST and DT cognitive function (the French adaptation of the harmonization standards neuropsychological battery, and eight cognitive-motor DTs), personal autonomy (functional independence measure), restrictions in participation (structured interview and the modified Rankin score), and health-related quality of life (on a visual analog scale). These variables will be assessed immediately after the end of the protocol (probing the short-term effect), 1 month thereafter (the medium-term effect), and 5 months thereafter (the long-term effect). DISCUSSION: The main study limitation is the open design. The trial will focus on a new GR program applicable at various stages after stroke and during neurological disease. TRIAL REGISTRATION: NCT03009773 . Registered on January 4, 2017.

Development and reliability of the coding system evaluating maternal sensitivity to social interactions with 34- to 36-week postmenstrual age preterm infants.

Maternal sensitivity (MS), the ability to perceive and synchronously respond to the social signals (SSs), is affected by prematurity. The development of early supportive psychotherapy to foster MS, before discharge of the infant from the neonatal intensive care unit (NICU) is a major challenge in the prevention of subsequent developmental and mental disorders in the child. There are currently no reliable methods for evaluating MS to social interactions with very to moderate preterm infants. We investigated the reliability of a newly developed procedure for assessing MS in interactions between the mother and her 34- to 36-week postmenstrual age (PMA) preterm infant: the Preterm Infant Coding System for Maternal Sensitivity (PRICOSMAS). Method: This study encompassed three steps: testing of the capacity to videorecord SSs in very to moderate preterm infants, selection, by an expert committee, of the recordable and relevant SSs, and investigation of the internal consistency and interrater reliability. The synchronicity between infant and mother's SSs was determined on a 1 s period basis, using ELAN software. Preterm infants born after 25-weeks gestational age (GA) were included while being between 34- and 36-weeks PMA. A perinatal risk inventory score > 10 for the infant precluded from inclusion. Interrater reliabilities were assessed independently by two raters blind to the clinical situation of the mother and infant. Results: The resulting PRICOSMAS encompassed two four-item SS sections, one covering the preterm infant's SSs and the other, the mother's SSs. Reliability was assessed on a sample of 26 videorecorded observations for 13 mother-preterm infant dyads. Infants' mean age at birth was 30.4 ± 3.1-weeks GA (range: 26.4-35) and PMA at the time of the test was 34.7-weeks (±0.8). Internal consistency ranged from 0.81 to 0.89. Interrater reliability ranged from substantial to almost perfect (0.73-0.88). Conclusion: This study shows that the infants' SSs and MS can be reliably scored in preterm infants as young as 34- to 36-weeks PMA. Our findings suggest that the PRICOSMAS is sufficiently reliable for use, including in NICU, by healthcare professionals or researchers for coding early parent-infant interactions with 34- to 36-week PMA preterm infants.

The added value of quality of life (QoL) for prognosis of overall survival in patients with palliative hepatocellular carcinoma.

BACKGROUND & AIMS: Several prognostic classifications (PCs) have been developed for use in palliative care in patients with hepatocellular carcinoma (HCC). We have recently suggested that CLIP combined with WHO PS has the greatest discriminative power. We evaluated the prognostic value of quality of life (QoL) data and whether the latter could improve classification of palliative HCC patients. METHODS: This was a reanalysis from the CHOC trial with an evaluation of the discriminative power for overall survival (OS) of the established CLIP/GRETCH/BCLC/BoBar prognostic systems alone and then in association with each of the following groups of parameters: selected clinical factors, QoL as continuous variables, dichotomized QoL, selected clinical factors and continuous QoL, selected clinical factors and dichotomized QoL. Baseline QoL was assessed using the EORTC QLQ-C30. Discriminative power was evaluated with the Harrell's C-index and net reclassification improvement. RESULTS: Quality of life was available in 79% of the patients (n=271). Univariate analysis revealed that better role functioning (HR=0.991 [0.987-0.995]) and better physical functioning (0.991 [0.984-0.997]) scores were associated with longer survival. In contrast, poorer score for fatigue (1.011 [1.006-1.015]) and diarrhoea (1.008 [1.002-1.013]) were associated with shorter survival. After adjustment for clinical and sociodemographic variables, only better role functioning score (0.993 [0.988-0.998]) was associated with longer survival. Adding oedema, hepatomegaly, fatigue and diarrhoea QoL scales to CLIP resulted in the best performance. CONCLUSIONS: Our results confirm that QoL scales are independent prognostic factors of OS in palliative HCC patients. Incorporation of QoL data improved all the studied PCs.