Clinical trials

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 body's nervous system control of pain. We plan to enroll 80 patients aged ≥55 years with confirmed KOA and frequent knee pain. 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, WOMAC score (a KOA-specific questionnaire), activity level, sleep quality, and quality of life. To explore underlying mechanisms, we will also measure 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). 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. We will also record any side effects or adverse events. 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.

This observational behavioural study examines whether individual differences in sleep quality, sleep timing, and chronotype are associated with prosocial allocation decisions in adults. Participants will complete self-report sleep and circadian questionnaires, including the Pittsburgh Sleep Quality Index and the Munich Chronotype Questionnaire, a 7-day sleep diary, and a brief computer-based Dictator Game allocation task. The study does not involve sleep deprivation, sleep restriction, treatment, clinical diagnosis, medication, or medical devices. Participants will not be asked to change their sleep schedule. The Dictator Game decisions are hypothetical and do not affect participants' compensation. The study is intended to describe associations between naturally occurring sleep-related individual differences and behavioural allocation choices, not to diagnose or treat sleep or mental health conditions.

People differ in chronotype - whether they function best in the morning ("larks") or the evening ("owls"). This study asks whether the match or mismatch between a person's chronotype and the time of day at which they are tested changes how they perceive time. Healthy morning-type and evening-type adults at three sites (Aarhus, Denmark; Changzhou, China; and Hong Kong) complete the same battery of perception and cognition tasks twice - once in the early morning (about 08:00) and once late in the evening (about 22:00), in counterbalanced order. The primary outcome is the accuracy (signed bias) of time-perception judgements; the key comparison is the interaction between chronotype and time of day (the "synchrony effect"). Secondary measures include timing precision, the subjective passage of time, sleepiness, mood, colour perception (with and without blue-blocking glasses) and perceptual decision-making. By testing the same protocol across three cultures and latitudes, the study examines whether circadian match/mismatch effects on temporal cognition generalise across populations.

This observational study aims to characterise individual differences in colour perception and binocular rivalry. Participants will complete computer-based visual perception tasks, including a colour perception task and a binocular rivalry task. The study will first examine whether individuals show measurable differences in these perceptual responses. It will then explore whether these differences are associated with chronotype, sex, sleep-related measures, and subjective fatigue. The findings may help clarify how stable individual characteristics and daily physiological states relate to visual perception.

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities. Fundamental to these cognitive and behavioral problems is the disordered cortical connectivity and resultant executive dysfunction that underpin the use of effective strategies to integrate information across contexts. Brain connectivity problems affect the rate at which information travels across the brain. Slow processing speed relates to a reduced capacity of executive function to recall and formulate thoughts and actions automatically, with the result that autistic children with poor processing speed have great difficulty learning or perceiving relationships across multiple experiences. In consequence, these children compensate for the impaired ability to integrate information from the environment by memorizing visual details or individual rules from each situation. This explains why children with autism tend to follow routines in precise detail and show great distress over seemingly trivial changes in the environment. To date, there is no known cure for ASD, and the disorder remains a highly disabling condition. Recently, a non-invasive brain stimulation technique, transcranial direct current Stimulation (tDCS) has shown great promise as a potentially effective and costeffective tool for reducing core symptoms such as anxiety, aggression, impulsivity, and inattention in patients with autism. This technique has been shown to modify behavior by inducing changes in cortical excitability and enhancing connectivity between the targeted brain areas. However, not all ASD patients respond to this intervention the same way and predicting the behavioral impact of tDCS in patients with ASD remains a clinical challenge. This proposed study thus aims to address these challenges by determining whether resting-state EEG and clinical data at baseline can be used to differentiate responders from non-responders to tDCS treatment. Findings from the study will provide new guidance for designing intervention programs for individuals with ASD.

The purpose of this study is to investigate the clinical efficacy and neurological progress of combined training using trans-spinal electrical stimulation (tsES) and neuromuscular electrical stimulation (NMES)-driven robotics on upper limb rehabilitation after stroke

In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.

A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.

The aims of this study are to test the effectiveness of a nurse support using a proactive mobile app to enhance parental self-efficacy in symptom management for children using mechanical ventilations, and alongside identify factors facilitating or deterring the program implementation. A single group pre-post quasi-experimental study on parents of CMC requiring mechanical ventilation. Parents will be recruited from a non-government office, with an estimated sample size of 52 parents. Self-administrated questionnaire, and semi-structured interview guide will be used for data collection.

Intermittent Exotropia (IXT) is a common type of eye misalignment where one eye periodically turns outward, and control is typically much worse when looking at objects far away than close up. However, most currently available training programme are focused on near-viewing tasks. The goal of this clinical trial is to investigate if a new, structured, home-based near eye training program works to improve distance eye alignment control in children and young adults with IXT. The main questions the study aims to answer are: * Does a 12-week near eye training program improve a participant's ability to control their eye alignment when looking at a distance? * Does using a special reading glasses during near training help to control distance eye alignment better than doing the training without the reading glasses? * Do the benefits of this eye training last after the training has stopped? This is a two- phase, single- masked (examiner masked), randomized clinical trial with crossover design. The entire study duration is about 24 weeks. A total sample size of 42 participants, aged 6 to 25 years with diagnosed Basic (distance deviation is within 10 prism diopters of the near deviation) or Divergence excess (distance deviation is at least 10 prism diopters greater than the near deviation) IXT, will be recruited. In Phase I (Weeks 0 to 12), participants will be randomly allocated into one of three groups, with 14 individuals in each group: * Group 1 does eye training while wearing special plus-power reading glasses that remove the need to focus up close, mimicking how the eyes look at a distance. * Group 2 does the exact same eye training but wears regular distance glasses without the special reading addition. * Group 3 serves as a control group that does not do training during the first 12 weeks, but will receive the training in the second phase. In Phase II (Weeks 13 to 24), which is a crossover phase, groups 1 and 2 will stop training to see if the visual improvements last, while group 3 will be re-randomized into two subgroups (group 3A, with special plus-power reading glasses, and group 3B with regular glasses with distance correction) that will undertake daily eye training for 12 weeks to ensure ethical treatment access. All participants will have a final eye exam at 24 weeks. During home training, participants will: * Wear standard glasses provided by the study. * Practice daily, home-based eye exercises for 12 weeks using a standardized software program on a computer or tablet. * Complete 3 training sessions every day, lasting 7 minutes per session. * Wear red-blue 3D glasses during training and press arrow keys or swipe the screen to play a visual game that dynamically changes in difficulty. Preliminary test and binocular vision assessment with fixed and uniform sequence will be performed at baseline visit, 6th week interim visit, 12th and 24th week evaluation. All eye examinations will be carried out in The Optometry Centre (A034), the School of Optometry, The Hong Kong Polytechnic University. The following data will be statistically analyzed. The primary outcome data is distance Office Control Score (OCS) at 12-week visit. Secondary outcomes data include change in deviation angle, near and distance stereopsis and patient- / parent- reported health-related quality-of-life questions at 12-week.

Insomnia is a prevalent sleep disorder associated with numerous adverse health outcomes, including fatigue, irritability, and impaired daytime functioning. Despite the availability of effective pharmacological and psychological treatments, relatively few individuals with insomnia seek professional help, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. Building on our previously registered pilot-testing protocol, this study aims to examine the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community population. Furthermore, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as cognitive behavioral therapy for insomnia (CBT-I) delivered via digital applications. Therefore, this study will also compare the effectiveness of theory-based SHE with a CBT-I app using a three-arm randomized controlled trial design.

The goal of this clinical trial is to evaluate an AI-integrated Emotional Granularity Growth intervention (AI-EGG) designed to enhance resilience and improve quality of life in young and middle-aged colorectal cancer (CRC) survivors. Emotional granularity refers to the ability to clearly identify and differentiate subtle emotional experiences, which may help individuals regulate emotions more effectively and build resilience after cancer treatment. The main questions it aims to answer are: * Does the AI-EGG intervention improve resilience in CRC survivors compared with routine psychological care? * Does the intervention improve emotional granularity, emotion regulation ability, and quality of life? * Is the AI-EGG intervention feasible and acceptable for young and middle-aged CRC survivors? Researchers will compare the AI-EGG intervention group to a control group receiving routine psychological care and standard educational materials to see whether the intervention leads to better psychological outcomes. Participants will: * Complete baseline assessments measuring emotional granularity, emotion regulation, resilience, and quality of life * Be randomly assigned to either the intervention group or the control group * In the intervention group, engage in a 4-week AI chatbot-based program focusing on emotional identification, differentiation, regulation, and reflective practice (at least two sessions per week) * In the control group, receive routine psychological care and standard educational materials * Complete post-intervention assessments immediately after the 4-week program and again at a 1-month follow-up * Some participants in the intervention group will be invited to complete interviews about their experience of the program

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)

Stroke is a type of cerebrovascular disease, and the primary characteristic of post-stroke brains is pathological changes in cerebral hemodynamics. Therefore, hemodynamic signals may provide straightforward information for guiding post-stroke neuromodulation therapy. Transcranial magnetic stimulation (TMS), a non-invasive neurostimulation modality, has been extensively used in post-stroke rehabilitation. However, current TMS-based neuromodulation therapy demonstrates a large treatment response variability due to its open-loop nature. To address this challenge, the research team will develop a novel form of closed-loop neurofeedback interfaces which controls the timing of TMS pulses precisely based on neural biomarkers from functional near-infrared spectroscopy (fNIRS) and test the accuracy of the adaptive neurofeedback system in healthy adults. After establishing the TMS-based neurofeedback interface, a proof-of-concept study enrolling postacute stroke patients will be performed to evaluate the efficacy of the TMS neurofeedback interface in enhancing motor control of the hemiplegic upper extremity and cortical excitability of the ipsilesional motor cortex. These findings will verify whether the proposed fNIRS-controlled TMS neurofeedback interface can be clinically feasible as a form of post-stroke neuromodulation therapy. Additionally, the results will significantly contribute to the scientific understanding of how neuromodulation improves hemodynamic signals in a closed-loop manner, thereby enhancing functional recovery in poststroke 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 qualitative study is to develop a therapy protocol for fathers of children with special needs in Hong Kong. The therapy is called Acceptance and Commitment Therapy (ACT), which helps people cope with difficult emotions by building psychological flexibility - the ability to accept and adjust to hard situations. The main questions it aims to answer are: 1. What are the experiences and needs of fathers raising children with special needs? 2. What content and format of an ACT programme would be most helpful for these fathers? Researchers will conduct focus group interviews with two groups of participants: fathers raising children with special needs and social workers who work with these families. The interviews will take about 60 to 90 minutes each. Participants will: 1. Take part in a recorded focus group interview 2. Share their experiences, challenges, and views on what an ACT program should include The findings will be used to develop a protocol for an ACT programme to improve the mental health of fathers raising children with special needs.

To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline.

Insomnia is a prevalent sleep disorder associated with substantial negative health consequences, including fatigue, irritability, and impaired daytime functioning. Although effective pharmacological and psychological treatments exist, fewer than half of individuals with insomnia seek professional treatment, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. However, previous studies have often underestimated the efficacy of SHE by using it as a passive control condition rather than an active, structured intervention. To address this limitation, the proposed pilot study aims to evaluate the feasibility and effectiveness of a theory-based, structured SHE program integrated with behavior change techniques.

The goal of this study is to investigate the myopic control efficacy of two study soft contact lenses in children. Participants will be prescribed Lens A, Lens B or single vision contact lenses for the first year. Participants in single vision contact lenses group will switch to Lens A at 12 months. All participants will then continue lens wear for an additional 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months for 2 years.

The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.

Lung cancer is the leading cause of cancer mortality, posing a critical public health challenge in both Hong Kong and global populations. Patients with lung cancer frequently experience a distressing symptom cluster characterized by breathlessness-driven respiratory distress, accompanied by persistent cough and fatigue, which collectively impose a substantial disease burden. While our research team leader previously developed and validated a multi-component Respiratory Distress Symptom Intervention (RDSI) in England, demonstrating clinical efficacy for lung cancer management, its impact on psychological distress (anxiety and depression) proved limited. This limitation may reflect insufficient integration of psychological components, a crucial consideration given the well-established bidirectional relationship between respiratory symptoms and psychological distress. Emerging evidence indicates that mindfulness interventions provide dual therapeutic benefits by improving patient adherence and effectively addressing both physical symptoms, such as breathlessness and fatigue, as well as psychological distress, including anxiety and depression. Meanwhile, current evaluation methodologies have mainly focused on behavioral data collection, such as self-reported questionnaires, to reflect the effect before and after the intervention. Neuroimaging data can help understand the brain mechanisms underlying breathlessness and elucidate the effectiveness of interventions, thereby improving intervention strategies.

Family caregivers of persons with dementia (PwD) are well known to be "invisible patients." Existing studies have suggested that sense of coherence (SOC), a core inner strength, could be a protective factor against depression among family caregivers of PwD. However, few interventions are available to enhance the SOC and thereby the emotional and psychological health of this population. While in-home social robots are viewed as a useful addition to caring for PwD, the use of social robots with family caregivers as the primary audience are vastly under-investigated. In response, the investigators have developed a strength-based, robot-assisted intervention based on Antonovsky's theory of saluotogenesis for family caregivers of PwD. The feasibility, acceptability, and preliminary effects of the robot on family caregivers of PwD have been confirmed, with recommendations for examining its applicability among this population in a full trial. This study aims to examine the effects of a salutogenic strength-based, robot-assisted intervention on improving depressive symptoms in family caregivers of PwD. This is a mixed-methods study, including a prospective, single-blinded, two-arm parallel randomized controlled trial and semi-structured individual interviews. A group of 148 family caregivers of PwD will be randomized to the intervention group (IG) or the control group (CG), who will receive reading materials on dementia care weekly. Each IG participant will engage with a robot integrated with an AI-powered chatbot at home for 6 weeks. Individual interviews will be conducted at week-6. Purposive sampling will be used to ensure diversity among the participants. Descriptive statistics, t-test and/or Chi square test, generalized estimating equation (GEE), linear regression and thematic analysis will be used. Primary hypothesis: Participants in the intervention group (IG) will report a greater improvement in depressive symptoms than the control group (CG) immediately postintervention at 6 weeks (T1), 1-month (T2) and 3-month (T3) after completing the intervention. Secondary hypothesis: 1) Participants in the IG will report a greater improvement in SOC, perceived caregiving burden, coping, and caregiving self-efficacy than the CG at T1, T2, and T3; 2) The frequency of engaging with specific robot features is associated with improved depressive symptoms, SOC, caregiving burden, coping, and caregiving self-efficacy. The findings may: 1) advance the understanding of the application of the salutogenesis theory to robotic technology, 2) boost the inner strength of family caregivers to maintain their emotional and psychological health in stressful situations, and provide a new paradigm to strengthen the informal care system.

The goal of this clinical trial is to assess the efficacy of combined aerobic and resistance training in enhancing physical reserve in older adults with physical frailty. Investigator contend that enhanced physical reserve will enable preservation of cognitive and physical function. The main questions aims to answer are: (1) Compared with usual care (i.e., CON), will 3-month aerobic and resistance training (ATRT) improve physical reserve in older adults with physical frailty? (2) Compared with CON, will ATRT lead to changes in the neural network organization? (3) Will improved physical reserve lead to better maintenance of cognitive and physical functioning in spite of presence of white matter hyperintensities (WMH)?

The primary objective of this study is to examine whether an ecological momentary intervention (EMI), combining behavioral self-monitoring (screen time screenshot uploads) and structured reflection, can enhance metacognitive awareness and metacognitive regulation in the context of recreational screen time among young adults. A secondary objective is to investigate whether improvements in metacognitive processes are associated with subsequent changes in behavioral and psychological outcomes, including recreational screen time (RST), stress, and life satisfaction. Furthermore, this study aims to elucidate the underlying mechanisms through which the intervention exerts its effects by integrating a randomized controlled trial (RCT) design with intensive longitudinal (daily diary) data. Specifically, the study addresses the following research questions: RQ1 (Primary Intervention Effect on Metacognition): Does the EMI lead to higher levels of daily metacognitive awareness and metacognitive regulation (planning, monitoring, and evaluation) compared to the control group? RQ2 (Within-person Associations): At the within-person level, do day-to-day fluctuations in metacognitive awareness and regulation predict same-day and next-day changes in recreational screen time, stress, and life satisfaction? RQ3 (Mediating Mechanism): Do increases in metacognitive awareness and regulation mediate the effects of the EMI on recreational screen time, stress, and life satisfaction? RQ4 (Between-person Effects): At the between-person level, do individuals in the intervention group exhibit higher average levels of metacognitive awareness and regulation, as well as lower recreational screen time and stress and higher life satisfaction, compared to those in the control group?

This study aims to develop and examine the feasibility and preliminary effectiveness of an AI-based sarcoma chatbot building on ChatGPT (ASCC) to address the information needs of sarcoma patients. We hypothesized: 1) the ASCC will demonstrate good usability; 2) the study will be feasible in terms of all feasibility indicators; 3) the experimental group will report improved satisfaction and self-efficacy, decreased anxiety and stress than the control groups upon completion of the intervention. The ASCC will be developed using a co-design approach. A pilot randomized controlled trial will then be conducted in the three oncology wards of collaborative hospitals. Seventy-eight sarcoma patients will be recruited and randomized to the experimental group (n=39) and the control group (n=39). The experimental group will use the ASCC available 24/7 via voice or text for disease-related questions for one month while the control group will receive usual care.