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Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.
POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.
The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.
Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are chronic inflammatory rheumatic diseases characterised by pain, fatigue, mood disturbances, sleep problems and reduced quality of life. These symptoms are highly variable both between individuals and within individuals across days, reflecting the fluctuating nature of disease activity and daily functioning. Although physical activity is known to alleviate many of these symptoms, individuals with RA and SpA often encounter barriers that limit regular engagement. Capturing the dynamic interplay between symptoms and physical activity therefore requires methods that account for day-to-day and moment-to-moment variability. Ecological momentary assessment (EMA), especially when combined with actigraphy, enables real-time, context-sensitive monitoring of symptoms and physical activity in daily life. However, little is known about the feasibility and acceptability of such protocols in individuals with RA and SpA, for whom participant burden and adherence may represent significant challenges. This pilot study therefore aims to assess the feasibility and acceptability of a 14-day EMA protocol and to explore factors associated with objectively measured physical activity in individuals with RA and SpA.
50 adults diagnosed with RA or SpA will be recruited through rheumatology clinics or via advertisement. Eligible participants must be smartphone users without cognitive or physical impairments affecting participation. After providing consent, participants will complete baseline questionnaires regarding disease activity, quality of life, sleep, pain, fatigue, affective states and will attend a remote session with a member of the research team to learn how to use the mobile app. They will then complete a 14-day EMA protocol, during which data on patient-related outcomes (PROs), including pain, fatigue, sleep quality and affective states (i.e. positive and negative affects) will be assessed four times daily: upon awakening, 11:00, 15:00 and 20:30. Physical activity and sleep will be continuously monitored using both a wrist-worn and a thigh-worn device. Feasibility will be evaluated based on adherence to EMA prompts and actigraphy wear time. Acceptability will be assessed via a study-specific questionnaire and qualitative interviews conducted at the end of the protocol. Exploratory analyses will examine real-time, temporal and lagged relationships between PROs (pain, fatigue affective states), sleep and physical activity levels.
This study was approved by the French national ethics committee [Comité de protection des personnes Nord Ouest I, 2025-A01349-40] on 24/07/2025. The results will be disseminated in peer-reviewed journals and at international conferences.
Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is an intensive rehabilitation programme for children with cerebral palsy (CP) delivered in a day camp setting recognised to promote the acquisition of specific functional abilities and independence. Currently, during HABIT-ILE camps, families are minimally involved in their child’s motor learning processes. This explains the challenges reported by both families and therapists, including difficulties in reinforcing skills at home, limited transfer to other functional goals and a lack of confidence in parents’ adaptive competence (self-determination and empowerment). Increasing family involvement in intensive motor rehabilitation programmes and the child’s developmental process by reinforcing skills at home could help reduce the parental impact of the child’s disability, enhance family satisfaction and strengthen their resources to support their child’s daily learning during and after the camp.
To address this, we developed the PARTNER programme, which combines HABIT-ILE with a structured home component focused on parent coaching.
We designed a non-inferiority, mixed-methods, multicentre randomised controlled trial to compare the efficacy at 3 months of the PARTNER programme (35 hours HABIT-ILE+15 hours home programme) with the standard HABIT-ILE programme (50 hours) on the bimanual performance (Assisting Hand Assessment) of children with unilateral CP aged 3–5 years. The secondary aims are to compare the 3-month efficacy of the programmes on occupational performance, functional skills and upper limb activity levels, as well as families’ resources, the parent–child relationship, the quantity and quality of resources available in the home to stimulate the child’s motor development, and parental perceptions of their child’s disability and their child’s abilities (qualitative study). The tertiary aim is to conduct a cost-effectiveness analysis of care consumption in each group up to 6 months after the end of the programmes.
Target recruitment is 66 children (33 in each group) from 3 centres in France. Outcomes will be evaluated before the interventions, immediately after, at 3 months and up to 6 months for the cost-effectiveness analysis. Families in the PARTNER group will receive specific coaching and extensive support to perform the home programme. The coaching will focus on enhancing their resources.
The study protocol has been reviewed, and ethics approval obtained from the Protection of Persons Committee (PPC) (PPC number: 2024-A01051-46). The results from this study will be actively disseminated through manuscript publications and conference presentations.
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