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.
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.
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.
Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.
This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.
This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.
Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg
ClinicalTrials.gov Identifier: NCT06633614
Adolescent idiopathic scoliosis (AIS) often imposes a significant psychological burden on teenagers. Cognitive and behavioural strategies have demonstrated the potential to alleviate these challenges. Chatbots, with their real-time interaction capabilities, provide a promising and accessible approach to delivering psychological interventions for young people.
This pilot trial will evaluate a chatbot-delivered, structured psychological intervention (SPI-Bot) incorporating cognitive and behavioural strategies for teenagers with AIS. Conducted as a single-centre, parallel-group randomised controlled trial, the study aims to assess the feasibility, acceptability and preliminary effectiveness of SPI-Bot. Fifty-two teenagers with AIS and mild to moderate psychological symptoms will be block-randomised into two groups. The intervention group will complete an 8-week, evidence-based SPI-Bot programme, while the control group will engage in casual conversations with another chatbot that does not include specific psychological health content. Assessments will be conducted at baseline, postintervention (8 weeks) and follow-up (12 weeks). Primary outcomes include feasibility and acceptability, measured through recruitment rates, adherence rates, attrition rates, engagement, working alliance, usability, user experience and adverse events. Secondary outcomes focus on effectiveness, including psychological distress, psychological well-being, perceived social support and quality of life. Participants in the intervention group will be purposively sampled for semistructured interviews to explore their perceptions of the intervention process.
This study has been approved by the Institutional Review Board of the Hong Kong Polytechnic University (Reference: HSEARS20240919007). The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.
Persons living with HIV (PLWH) have an augmented risk of cardiovascular disease, including atherosclerosis and myocardial dysfunction, despite effective viral suppression with antiretroviral therapy. Despite the majority of PLWH residing in sub-Saharan Africa, there are limited reports from the region on structural cardiovascular changes due to this residual risk.
The Early Structural Cardiovascular Disease, HIV, and Tuberculosis in East Africa (ASANTE) cross-sectional study will be conducted in a public hospital in Nairobi, Kenya. It will enrol 400 participants (50% women, 50% PLWH) to undergo cardiovascular phenotyping using multimodal imaging (coronary CT angiography (CCTA) and echocardiography) and banking of biological samples (whole blood, peripheral blood mononuclear cells, plasma and urine). We will define the prevalence of subclinical coronary atherosclerosis by CCTA and subclinical myocardial dysfunction by transthoracic echocardiography and evaluate both traditional and non-traditional risk factors, including endemic infections such as latent tuberculosis. This study will contribute important data on phenotypes of and risk factors for HIV-associated cardiovascular disease in this understudied region.
Ethical approval for the ASANTE study was granted by the University of Nairobi-Kenyatta National Hospital Ethical Review Committee, Nairobi, Kenya, and the University of Washington Institutional Review Board, USA. Results will be submitted for publication in peer-reviewed journals.