Clinical trials

Neurogenic overactive bladder (nOAB) is a common and distressing sequela following stroke, significantly impairing quality of life and imposing a substantial financial burden. Existing pharmacological options often present adverse effects, while standard non-pharmacological treatments, such as pelvic floor muscle training (PFMT), face compliance and efficacy limitations in individuals with functional impairments. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique capable of modulating neuronal excitability and cortical plasticity. Targeting the supplementary motor area (SMA) via tDCS may regulate pelvic floor muscle (PFM) and detrusor activities. However, clinical evidence evaluating tDCS as an adjuvant to PFMT for stroke survivors with nOAB is lacking. This randomized controlled pilot trial aims to evaluate the feasibility, preliminary effectiveness, and cost-utility of active tDCS combined with PFMT compared to sham tDCS plus PFMT in stroke survivors suffering from nOAB.

Stroke commonly results in persistent leg impairments that limit mobility and reduce quality of life. This study investigates whether combining low-intensity resistance training with blood flow restriction (LIRT-BFR) and transcutaneous electrical nerve stimulation (TENS) can effectively improve leg function in stroke survivors. Participants with chronic stroke will be randomly assigned to one of four intervention groups: 1) LIRT with simulated BFR and simulated TENS; 2) LIRT with actual BFR and simulated TENS; 3) LIRT with simulated BFR and actual TENS; 4) LIRT with both actual BFR and actual TENS. The resistance training utilizes 20% of each participant's maximum lifting capacity. For blood flow restriction, an automated pressure cuff (SmartCuffs 4.0) will be placed on the upper portion of the affected leg, inflated to 50% of the individual's occlusion pressure during exercises and deflated during rest periods. TENS therapy delivers controlled electrical impulses through electrodes positioned on the anterior thigh. Each 60-minute session includes a 10-minute warm-up followed by 40 minutes of targeted resistance exercises (leg extensions, leg presses, and weight-bearing squats) and concludes with 10 minutes of stationary cycling. The resistance protocol involves 3 sets of 20 repetitions with standardized rest intervals between sets and exercises. Participants will attend three sessions weekly for six weeks. Assessments will be conducted at baseline, midpoint (3 weeks), completion (6 weeks), and follow-up (1 month post-intervention). The primary outcome measure is the Fugl-Meyer Assessment for Lower Extremity function, with secondary measures including muscle strength, stiffness, balance, mobility, walking capacity, and gait parameters. To understand the underlying mechanisms, we will measure muscle oxygenation using near-infrared spectroscopy, evaluate muscle structure via ultrasound, and monitor physiological responses including heart rate variability and perceived exertion for safety monitoring.

The goal of this clinical trial is to use different tES techniques to constantly stimulate the cerebellum in older glaucoma patients. The main questions aim to answer : 1. If the different types of tES targeting the cerebellum can modulate glaucoma patients' balance function and visual-cognitive function? 2. Which tES techniques among the two types can benefit most? Participants will be required to receive the stimulation 15 times (3 sessions, 5 continuous days/session, 1-week interval between each session), and complete the balance and visual-cognitive function outcome measurements before and after each session.

This study aims to understand whether learning music can help improve brain function and quality of life in children who have recovered from brain tumours. A total of 236 children will join the study. Some of them will receive regular medical care, while others will take part in a music training program using the ukulele. The music program will last for one year and includes both in-person group classes and online individual sessions. The investigators will assess how well the children can think, remember, and focus before and after the training. The investigators will also ask about their daily life and well-being. This study hopes to show that music training can be a fun and helpful way to support recovery in childhood brain tumour survivors.

The goal of this clinical trial is to learn if telephone-based Acceptance and Commitment Therapy (ACT) works to help young adults with hazardous or harmful alcohol use quit drinking. It will also learn about the psychological effects of ACT on participants. The main questions it aims to answer are: 1. Does telephone-based ACT increase the number of participants who quit drinking, as confirmed by a urine test? 2. Does telephone-based ACT help participants reduce their alcohol consumption and improve their psychological flexibility? Researchers will compare telephone-based ACT to a telephone-based social support programme to see if ACT works to help young adults quit drinking. Participants will: 1. Receive telephone-based ACT or social support once a week for 6 weeks Complete questionnaires about their alcohol use and psychological flexibility. 2. Keep a record of their daily alcohol consumption throughout the study using a standardised diary method. 3. Provide a urine sample at the 6-month follow-up if they report having quit drinking

The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are: 1. Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)? 2. Is the programme acceptable to participants? 3. Does the programme show early signals of improving diabetes management self-efficacy and related outcomes? Researchers will compare the Chinese medicine education programme to usual care to see if the programme is feasible, acceptable and shows preliminary benefits. Participants will: 1. Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care 2. Complete assessments at baseline, after the programme, and at 2-month follow-up. 3. Attend a focus group interview at the end of the study (selected participants) Outcome assessors will be blinded to group allocation.

The study examines (1) the effects of active anodal (facilitatory) tDCS and yoga combined intervention on cognitive function, clinical symptoms, and quality of life domains (social function and physical wellbeing) in psychosis, and (2) the neurophysiological mechanisms underlying the effects induced by the combined intervention.

The aging population in Hong Kong is projected to reach 36.6% by 2046, with roughly 16.6% of older adults estimated to be mildly frail-a condition linked to higher risks of falls, hospitalization, and mortality. While physical activity (PA) is a key modifiable determinant of frailty, a major service gap exists for mildly frail older adults, who lack tailored support, resources, and long-term self-management programs. Although Hong Kong features over 440 public open spaces equipped with senior-friendly outdoor exercise facilities (OEFs), older adults often lack awareness and knowledge on how to utilize them safely for aerobic, strength, and balance training. Furthermore, existing PA interventions often overlook social-ecological perspectives and fail to optimize built environment resources or address digital literacy barriers to sustain long-term behavior change. To bridge these gaps, our team developed and preliminary-tested OUTDOOR-FIT, a complex, theory-driven, socio-ecological mHealth intervention. OUTDOOR-FIT synergizes Hong Kong's built environment (OEFs), social and volunteer support, individual goal-setting, and digital health technology (a contextually tailored mobile Application) to empower mildly frail older adults to self-manage their PA habits. Building upon promising preliminary findings and qualitative feedback from our initial pilot RCT, the intervention has been refined to incorporate neighborhood OEF environmental audits, supervised outdoor experiential practice sessions, and a train-the-trainer volunteer model to support digital literacy and engagement. The main objective of this study is to evaluate the clinical effectiveness and real-world implementation of the refined OUTDOOR-FIT intervention using a hybrid type 1 effectiveness-implementation design. Primary effectiveness outcomes include physical activity levels, exercise self-efficacy, mental well-being, chronic pain, and social loneliness measured immediately post-intervention, as well as at 3-month and 6-month follow-ups. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, secondary implementation outcomes include Reach, Effectiveness, Adoption, Implementation fidelity, and Organizational Maintenance. This study adopts a mixed-methods design embedded within a two-arm cluster randomized controlled trial (cluster RCT) involving community service units. Mildly frail older adults will be cluster-randomized into either (i) the OUTDOOR-FIT intervention group or (ii) a control group. Quantitative analysis will be conducted to evaluate the immediate and sustained effectiveness of the intervention across the primary health outcomes. The qualitative component will consist of semi-structured interviews with older adult participants and community stakeholders to evaluate intervention adoption, implementation barriers, and long-term organizational maintenance.

The goal of this randomized controlled trial is to determine whether using both brain and muscle signals to control a wrist-hand rehabilitation robot can improve recovery in people with chronic stroke. A total of 48 participants will be randomly assigned to one of two groups. Both groups will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton rehabilitation robot. In the closed-loop sensorimotor integrated group, the system will use information from both brain-muscle coordination and muscle activity to recognize the participant's movement intention and provide electrical stimulation and robotic assistance. In the electromyography-driven group, the system will use muscle activity alone to control the electrical stimulation and robotic assistance. The main questions this study aims to answer are: Does control using both brain and muscle signals improve wrist and hand motor function more than control using muscle signals alone? Does this approach produce greater changes in coordination between the brain and muscles? Participants will complete motor-function and brain-muscle assessments before training, immediately after the 20 training sessions, and 3 months after training.

The study will investigate the (1) additive and synergistic effects of tDCS and aerobic exercise on cognitive function and clinical symptoms in schizophrenia, and (2) neurophysiological mechanisms (mediators) underlying these effects.

The goal of this study is to learn if a parent-child dyadic physical activity (PA) intervention works to improve physical activity levels in children with leukaemia. It will also learn about the intervention's effects on children's self-confidence in doing physical activity and their quality of life. The main questions it aims to answer are: Does the dyadic PA intervention increase the amount of physical activity children do, compared with an individual PA intervention or usual care? Does the dyadic PA intervention improve children's confidence in doing physical activity and their overall quality of life? What is the cost-effectiveness of the dyadic intervention relative to the individual intervention and psychological support control group? Researchers will compare three groups: children and parents doing physical activity together (dyadic intervention), children doing physical activity individually (individual intervention), and children receiving psychological support sessions only (control group), to see if involving parents makes a difference. Participants will: Attend weekly sessions for 3 months (12 sessions total) Wear an activity tracker for 7 days and complete questionnaires at 5 different time points over 12 months Some participants will also be invited to take part in an interview about their experience

Reproductive health has emerged as a critical yet overlooked concern among Adolescent and Young Adult (AYA) cancer survivors, given their compromised potential for biological parenthood in prime childbearing years. Large language models (LLMs) offer a promising solution to bridge onco-fertility service gaps by integrating evidence-based knowledge and therapeutic frameworks. This pilot randomized controlled trial aims to assess the feasibility and preliminary effectiveness of an LLM-driven chatbot versus electronic brochure in addressing reproductive concerns among AYA cancer survivors.

This randomized, single-blind, placebo-controlled clinical trial aims to investigate the immediate physiological effects of a single session of electroacupuncture (EA) on neck muscle stiffness in individuals with chronic neck pain. While acupuncture is a widely used complementary therapy for musculoskeletal pain, high-quality, objective evidence demonstrating its immediate effects on muscle biomechanics remains limited. This study will utilize Shear Wave Elastography (SWE)-a non-invasive, objective ultrasound-based technology-to measure these changes. Adult participants aged 18 to 65 with non-specific chronic neck pain (lasting ≥ 3 months) will be randomly allocated into one of two groups: 1. True Electroacupuncture (EA) Group: Participants will receive a 20-minute session of active electroacupuncture with comfortable electrical stimulation at specific neck and tender points. 2. Sham Acupuncture (Placebo) Group: Participants will receive a 20-minute session of non-penetrating sham acupuncture with a deactivated electroacupuncture device to ensure participant blinding. The primary objective is to evaluate immediate changes in the stiffness of the upper trapezius muscle, measured objectively via SWE (as Young's Modulus in kPa) before and immediately after the intervention. Secondary objectives include assessing immediate post-treatment changes in subjective pain and stiffness (Visual Analogue Scale), Pressure Pain Threshold (PPT), and active Cervical Range of Motion (CROM), alongside a 7-day post-intervention follow-up questionnaire on neck function.

Background With population ageing accelerating worldwide, long-term care needs are rising, and family caregivers have become an essential yet often under-recognised component of care systems. Older family caregivers are particularly susceptible to frailty because they shoulder substantial caregiving responsibilities while simultaneously experiencing their own age-related decline in health and physiological reserve. Frailty is a clinically important state of heightened vulnerability to stressors and is associated with serious adverse outcomes, including disability, hospitalisation, and mortality. In family caregivers, frailty may compromise not only health and quality of life, but also their capacity to sustain caregiving, with wider implications for the sustainability of family-based long-term care. Research gaps A scoping review conducted by this team indicated that middle-aged and older family caregivers, particularly spousal caregivers, are vulnerable to frailty, with caregiving-related, sociodemographic, physical, psychological, and social factors contributing to this condition. However, existing evidence remains fragmented. Caregiver-specific prognostic tools for estimating future frailty risk are lacking, and risk-stratified interventions among family caregivers are sparse. Aim This study aims to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers, identify modifiable risk factors, as well as develop and preliminarily evaluate a risk-stratified, social robot-assisted intervention to reduce the risk of frailty. Methods This study comprises four phases. Phase 1 is a completed scoping review that mapped evidence on frailty among middle-aged and older family caregivers. Phase 2 will use longitudinal data from the China Health and Retirement Longitudinal Study (CHARLS) to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers and to construct an online risk calculator. Phase 3 will develop social robot-assisted intervention based on the Capability, Opportunity, Motivation-Behavior (COM-B) model. Phase 4 will assess the feasibility, acceptability, and examine preliminary effects of the intervention. Expected outcomes This study is expected to provide a caregiver-specific tool for early frailty risk identification and risk stratification among middle-aged and older spousal caregivers. It will also generate a theoretically guided, risk-stratified social robot-assisted intervention targeting modifiable risk factors for frailty and provide evidence on its feasibility and acceptability, as well as preliminary effects. The findings will inform a future definitive large-scale trial and community-based caregiver support services.

The goal of this clinical trial is to learn if a digitalised Exercise Fit Tool (EFT) mobile application can promote physical activity in adolescents aged 12-18 years who have completed treatment for hematologic cancer (e.g., leukaemia and lymphoma). The main questions it aims to answer are: 1. Is it feasible to conduct a larger randomised controlled trial of the digitalised EFT intervention? 2. Does the digitalised EFT intervention improve physical activity levels, physical activity self-efficacy, and quality of life at 6 months? Researchers will compare the digitalised EFT intervention group to a usual care group to see if the mobile application can promote physical activity levels, physical activity self-efficacy, and quality of life in adolescents with hematologic cancer.Participants will: 1. Receive a 20-minute educational session on how to use the mobile application 2. Use the mobile application to self-assess their appropriate physical activity level and exercise with a virtual coach 3. Complete questionnaires and wear an accelerometer at 1, 3, and 6 months after enrollment 4. Attend a 20-30-minute individual interview at 6 months (intervention group only, 10 participants)

Suicide is a major public health concern and there is a need for accessible and scalable interventions to support individuals experiencing suicidal thoughts. The aim of this study is to develop a digital Acceptance and Commitment Therapy (ACT) intervention for suicide prevention in Chinese adults through co-design. The study will involve literature review, interviews, and co-design activities to identify user needs, preferences, and contextual factors, and to develop the intervention. Following intervention development, a pilot study will be conducted to evaluate the feasibility, usability, acceptability, and user engagement of the intervention. Findings from this study will inform further refinement of the intervention and future evaluation studies.

This prospective, multicenter, non-interventional observational study aims to evaluate the agreement between a novel swept-source optical coherence tomography (SS-OCT) biometer and the IOLMaster 700 for ocular biometric measurements and to develop and validate an artificial intelligence (AI)-driven intraocular lens (IOL) power prediction model. The primary research questions are: Does the novel SS-OCT biometer provide ocular biometric measurements that are comparable to those obtained using the IOLMaster 700? Can an AI-driven IOL power prediction model developed from multicenter biometric, imaging, surgical, and postoperative refractive data improve the accuracy of postoperative refractive prediction? Adult patients with age-related cataract who are scheduled to undergo routine phacoemulsification with posterior chamber IOL implantation will be consecutively recruited from participating study centers. Participants will undergo routine preoperative clinical assessments together with additional non-contact biometric measurements using the novel SS-OCT biometer before cataract surgery. Cataract surgery and postoperative care will follow standard clinical practice and will not be influenced by the study. Postoperative refractive and visual outcomes at approximately one month after surgery will be collected for analysis. The AI model and research device measurements will be used for research purposes only and will not be used to guide clinical decision-making during the study.

Abstract Objectives To assess the effectiveness of a web-based gamified auditory-cognitive dual-task training (ACDT) in improving the everyday listening abilities of older adults with hearing loss (HL), including speech perception performance, cognition, and self-reported hearing. Hypothesis to be tested ACDT participants will show significantly greater improvements in 1) self-reported hearing; 2) speech perception-in-noise; 3) attention; 4) reasoning; and 5) dual-task of listening and working memory compared to the control group at week 6, immediately post-intervention, and week 24. Design and subjects A prospective, single-blinded, two-arm parallel randomized controlled trial with individual semi-structured interviews. 164 Chinese adults aged 60 years or older, who speak Cantonese or Putonghua, and have mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears. Study instruments A web-based gamified auditory-cognitive dual-task training. Interventions This is a 12-week program conducted five times a week, with each session lasting 60 minutes, following a sequential dual-task training design. Each session includes auditory training in speech-in-noise, rapid speech, and competing speaker, and cognitive training focusing on executive function, perceptual-motor ability, memory, and complex attention. Main outcome measures Self-reported hearing (untrained); Speech perception in noise (trained), attention in listening and sustained selective attention (trained), reasoning (trained), and dual-task of listening and working memory; complex span working memory (trained). Data analysis Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used. Expected results ACDT significantly improves the everyday listening abilities of older adults with HL.

The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation.

This mixed-method study comprises a RCT with a twelve-week post-intervention follow-up and focus group interviews. The RCT study aims to examine the effectiveness of delivering the tgCBFI programme to dyads of people with schizophrenia and their family caregivers, while the focus group interviews aim to qualitatively study the benefits of the tgCBFI programme from the service users and their family caregivers to provide a more in-depth understanding and complement the quantitative data. The main questions it aims to answer are: Does this online tgCBFI programme reduce the expressed emotion experienced and positive and negative symptoms of individuals with schizophrenia? Does this online tgCBFI programme reduce the perceived care burden and level of mood disturbances of family caregivers?

This is a single-blinded study. Participants will be randomly assigned to self-initiated perturbation-based balance training (SePBT) group or control (conventional balance training) group. Kinematic and Kinetic changes following SePBT group compared to control will be investigated.

This is a two-arm, parallel-group randomized controlled feasibility trial involving 40 community-dwelling adults with chronic stroke and ongoing sleep or circadian difficulties. Participants will be randomly assigned in a 1:1 ratio to either an individualized behavioral sleep intervention or an attention-matched health education program. Before randomization, participants will complete questionnaires assessing sleep and related health outcomes, maintain a sleep diary, and wear a wrist-worn activity monitor for seven days. Participants will then attend six weekly, individual, face-to-face sessions lasting approximately one hour each. The behavioral sleep intervention will provide individualized education and behavioral strategies to support sleep and daily sleep-wake functioning following stroke. The comparison program will provide education about stroke, sleep, and general health. The two programs will be matched in session frequency and duration. Following the six-week program, participants will repeat the questionnaires, sleep diary, and seven-day wrist-monitoring assessment. Participants will also provide feedback about their experiences with the study and program. The trial will evaluate recruitment, retention, attendance, intervention delivery, acceptability, fidelity, and safety. Preliminary changes in sleep and sleep-wake outcomes will also be examined.

This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a six-week behavioral intervention designed to improve mood and daily functioning in adults who have experienced a stroke and report depressive symptoms and difficulty becoming engaged in activities after waking. Participants will be randomly assigned to either the behavioral intervention or a health education program. Assessments will be completed before and immediately after the six-week program and will include questionnaires and seven-day monitoring of sleep, activity, and mood. The study will also examine feasibility indices such as participant retention, intervention attendance, acceptability, and preliminary changes in mood.

A two-arm randomized controlled trial (RCT) will be conducted to test a mobile-based intervention, E-breathing, for early detection and intervention to address psychological distress in at-risk adolescents in Hong Kong. E-breathing harnesses the science of real-time, in-situ assessment approach - Ecological Momentary Assessment (EMA) - to capture the psychological symptoms and needs of adolescents. Based on the real-time data collected via smartphone, the mobile application prompts the practice of slow-paced breathing as an Ecological Momentary Intervention (EMI) to reduce psychological distress. This RCT will recruit a total of 100 participants who will be randomly allocated to either (1) an intervention group (EMI group), where they will receive a feedback prompt when they score high on negative affect (i.e., E-breathing) or (2) the control group (EMA group), where they will only complete EMAs without feedback. This project aims to investigate the feasibility and effectiveness of E-breathing in improving psychological symptoms in Hong Kong adolescents. This project also examine the underlying physio-mechanisms of the effects of E-breathing on psychological outcomes in this target population.

Knee osteoarthritis (KOA) is a common joint disease that causes chronic pain and limits daily activities. Current treatments, such as painkillers or surgery, have limitations like side effects or high costs. This study will test whether a safe, non-drug intervention-inspiratory muscle training (breathing exercises against resistance)-can reduce knee pain in people with KOA. The training may work by lowering inflammation and improving the brain's modulation of pain. Eighty patients aged ≥55 years with confirmed KOA and frequent knee pain will be enrolled. Participants will be randomly assigned to either an 8-week inspiratory muscle training program (5 sessions per week, with gradually increasing resistance) or a sham (very low resistance) training program. Neither the patients nor the researchers assessing the outcomes will know who is in which group. The main outcome is change in knee pain measured by a visual analog scale (VAS). Secondary outcomes include blood markers of inflammation (TNF-α, IL-6, IL1β), physical function, the Knee injury and Osteoarthritis Outcome Score (KOOS), inspiratory muscle strength, activity level, sleep quality, and quality of life. To explore underlying mechanisms, outcomes included heart rate variability (HRV) as an indicator of autonomic nervous system function, and brain functional connectivity in the prefrontal cortex using functional near-infrared spectroscopy (fNIRS) are collected. These mechanistic assessments will be performed at baseline and at the end of 8-week intervention. Additional follow-up assessments for clinical outcomes will be done at 3 and 6 months after the training ends. Any side effects or adverse events will be recorded. This study will provide high-quality evidence on whether inspiratory muscle training is an effective and safe complementary treatment for knee pain in people with knee OA, and will offer new insights into the mechanisms underlying its analgesic effects.