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AnteayerBMJ Open

Effectiveness of exoskeleton training on turning-while-walking and balance control in subjects with incomplete spinal cord injury: protocol for a randomised clinical trial

Por: Chen · M. · Chan · C. W.-n. · Wang · P. Y. · Tsang · W. W.-n.
Introduction

Individuals with incomplete spinal cord injury (iSCI) often experience impaired balance control and turning-while-walking ability, which increase the risk of falls and limit their community mobility. While overground exoskeleton training has shown promise in improving gait and balance, evidence from randomised controlled trials (RCTs) on ambulation of individuals with iSCI remains limited. This protocol outlines a cluster RCT investigating the effectiveness of overground exoskeleton-assisted gait training compared with conventional training and usual care in improving turning-while-walking performence, balance control, and functional mobility in individuals with iSCI.

Methods and analysis

This multicentre, cluster RCT will compare 12-week interventions across three groups: (1) overground exoskeleton training group, (2) conventional training group and (3) usual care group. Participants with ambulatory iSCI will be recruited from three centres in Hong Kong SAR and mainland China. Primary outcomes include turning duration and number of steps during a 2-m turning-while-walking test. Secondary outcomes include static and dynamic balance, sensorimotor integration, gait performance, muscle strength, spasticity, quality of life, self-efficacy and fall incidence. Assessments will be conducted at baseline, mid-intervention, postintervention and at the 1-month follow-up.

Ethics and dissemination

This study has received approval from the Research Ethics Committees of Hong Kong Metropolitan University, the Affiliated BenQ Hospital of Nanjing Medical University, and Changzhou Sunshine Rehabilitation Hospital. Written informed consent will be obtained from all participants before enrolment. Study findings will be shared through peer-reviewed publications, conference presentations and summaries available to participants upon request.

Trial registration number

NCT06971510.

Development of prison-based parent-child joint intervention for incarcerated fathers: protocol for mixed-methods study

Por: Yiu · W. Y. · Fung · Y. L. · Tsang · S. K. M. · Chan · C. H. Y. · Wong · P. W. C.
Introduction

Paternal incarceration represents a significant stressor that disrupts family cohesion, undermines paternal identity and adversely affects children’s psychosocial well-being. While family-focused programmes show promise in improving outcomes for incarcerated parents and their children, culturally attuned prison-based parenting interventions remain underdeveloped and scarce, particularly in Asian contexts. To address this gap, a local parenting intervention grounded in the Double ABCX model of family resilience, the ‘Be My Hero’ programme, was designed for incarcerated fathers in Hong Kong, China.

Methods and analysis

A concurrent mixed-methods design will be used to evaluate the intervention. A convenience sample of 20–30 incarcerated fathers of children aged 3–11 will be recruited from three correctional facilities. Quantitative measures assessing paternal competence, father–child attachment, communication and resilience will be collected preintervention and postintervention. Qualitative data will be triangulated through semistructured interviews with participants, their children and social workers, supplemented by session logs documenting perceived shifts in paternal identity and programme feasibility. The intervention is expected to mitigate disruptions in paternal identity and strengthen father–child bonds. This may, in turn, reduce intergenerational disadvantage and improve overall family well-being.

Ethics and dissemination

This study has received ethical approval from The University of Hong Kong. Informed consent and assent will be obtained from the participants, their children and current guardians. Findings will be disseminated through peer-reviewed journals or conferences to inform correctional rehabilitation practices, encouraging the integration of family-focused and resilience-based approaches. Stakeholders, including practitioners and policymakers, may adopt similar interventions to promote healthier re-entry outcomes and reduce intergenerational disadvantage.

Antibiotic stewardship in suspected neutropenic fever (ASTERIC trial): a multicentre, type 1 hybrid effectiveness-implementation, stepped-wedge, randomised controlled trial study protocol

Por: Rainer · T. H. · Lam · R. P. K. · Tsang · T. C. · Wai · A. K.-C. · Leung · S. C. · Leung · R. Y. Y. · Wong · C. K. H. · Gill · H. · Lam · W. W. T. · Wing Lok Chan · W. · Chi Kin Cheung · A. · Lau · M. T. · Lee · S. F. · Choi · Y. F. · Fong Lun Lee · H. · Mok · K. L. · Lam · H. C. · Lee
Introduction

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

Methods and analysis

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

Ethics and dissemination

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

Trial registration number

NCT06794320.

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