ANZCTR search results

This study will test the efficacy of a novel therapeutic exercise machine at improving symptoms of Parkinson's disease and their neurological underpinnings in patients with Parkinson's Disease and Atypical Parkinsonism. The Reviver exercise machine simultaneously stimulates the vestibular system whilst inducing isometric exercise. We hypothesise that a 12 week intervention on the Reviver will improve balance, mobility, and other motor symptoms of Parkinson's Disease.

This study will develop methods for Australian education systems to help identify young people (aged 9-17) who are struggling with emotional disorders. We will develop an initial screening tool containing measures that will assess emotional disorders, as well as interpersonal relations with family and friends and lifestyle habits, which will be tested in a total of 100 schools. This initial screening tool will be delivered to an "immediate screening" group (n=50 schools) and tested in students in Year 4 through to Year 11 across different school sectors, socioeconomic levels, ages, cultural groups, as well as rural and urban schools. Students identified from their responses to the screener as being at-risk of emotional disorders will be flagged with the school and referred to appropriate pathways to care that we will have identified through input and feedback from students, parents, educators and policy-makers. To validate our screening tool, we will ask students and parents to complete clinical interviews and measures of prior help-seeking and quality of life, and also ask for access to school data on student attendance and academic performance. Using these validators, we will develop from the initial screener a shortened version that has as few items as possible, while being sensitive enough to accurately detect at-risk students. This final screener will be delivered to those in the "immediate screening" group 9 months after the initial screener. It will also be tested using a comparison "delayed screening" group (n=50 schools) to determine whether the screening and care process leads to a greater number of young people with emotional disorders getting the help that they need. Finally, we will measure costs and benefits and will conduct economic modelling to estimate how much these processes can save the Australian community. We will also assess the acceptability of school-based screening from the perspectives of students, parents and schools.

Paradigm Biopharmaceuticals Ltd (Paradigm) is evaluating Pentosan Polysulfate Sodium (PPS) for the treatment of symptoms (pain and diminished function) and mitigation of underlying tissue degeneration associated with osteoarthritis (OA) of the knee.. This study is designed to measure synovial fluid biomarkers indicative of the inflammation and cartilage degradation present in symptomatic knee OA, and to determine quantitative changes in individual biomarkers resulting from treatment with PPS. The results from this study will enhance understanding of the PPS mechanism of action and will provide information on the effect of PPS on joint inflammation and on the processes responsible for OA disease progression.

The associated morbidity from rheumatic heart disease (RHD) is the leading driver of cardiovascular inequality for Indigenous Australians. Across the Tasman, its precursor acute rheumatic fever (ARF) and RHD almost exclusively affect Maori and Pacific children and young adults living in socio-economically deprived areas of the North Island of New Zealand. For 70 years, the only proven way to prevent ARF progression has been benzathine penicillin G (BPG), given as a monthly intramuscular (IM) injection. The effectiveness of this approach is limited by pain and the frequency of injection which leads to sub- optimal adherence in these vulnerable groups. There is an urgent need to improve penicillin formulations for all children living with ARF/RHD. Based on a randomised cross-over trial conducted by our team, we hypothesise that BPG could be repurposed as an ‘implant’ if given as a high-dose subcutaneous (SC) infusion of penicillin (SCIP). By providing sustained penicillin concentrations for >3 months, this approach would fulfil the ideal product characteristics for the next generation of long-acting penicillins. This 3-year multiphase program begins with a phase 1 study, assessing the safety, tolerability and pharmacokinetics of SCIP in healthy adults (SCIP-I). If SCIP appears tolerable and provides sustained penicillin concentrations, we will perform an observational study of SCIP in children living with ARF (SCIP-II). Concurrently, we will implement mixed-methods studies to identify acceptability, barriers and benefits of SCIP RHD, both from consumer and health care provider perspectives (SCIP-IIa).

Virtual reality (VR) shows promise in rehabilitation. With the advent of new technologies, such as the Oculus Quest, immersive technologies have become more available and cost effective. We plan to compare VR rehabilitation therapy to standard therapy for older adults who are undergoing inpatient rehabilitation. Our hypothesis is that the use of VR exercises is feasible, acceptable to therapists and patients, improves the experience of rehabilitation, as well as improve functional performance in rehabilitation patients.

The purpose of the feasibility pilot is to assess the ease of use of Remote Check on Android smart phones when used by adult Cochlear Implant recipients, in terms of usability and software issues, for the completion of primary tasks. Usability will be assessed using a ranking scale and questionnaire. Software issues/bugs relevant to the use of Remote Check on Android will be logged and used to inform any product enhancements required. The study will also characterise the test retest difference of Aided Threshold Test (AAT) and Digit Triplet Test (DTT) when streamed via Android smart phones.

Road crashes are a major cause of death and disability for young Australians. Fatigue is a major contributor to road crash, and is primarily due to insufficient sleep. Young adults frequently lose sleep due to developmental, social, work, and education demands. This project uses a brief but potentially powerful behavioural program to extend habitual sleep, reduce sleepiness while driving, and reduce driving risk. The program could reduce the very high medical, social, and individual costs of road trauma.

This research project is being conducted to look at the safety, tolerability and pharmacokinetics (PK, how the human body processes a substance) of TTI-0102 when given to healthy volunteers orally as a single dose, compared with a single oral dose of the marketed product Cystagon (registered trademark). It is proposed that TTI-0102 could be used as a treatment for acute respiratory distress syndrome (ARDS) related to COVID-19 infection.

This study will seek to evaluate the generation of droplets and aerosol during high intensity exercise. We will characterise the droplet and aerosol size, volume and direction in an indoor environment during high intensity exercise in athletes. These measurements will be done with the participants wearing no mask or a surgical mask and sampling will happen at different distances and locations. We will compare the concentration of droplets/aerosol at 3 different distances of .3, 1.5 and 3 metres from the participant with and without a surgical mask.

The aim of the current study is to explore the effect of an online mindfulness program (iMindTime) on depression, anxiety and stress. The iMindTime program is a digital health program that comprises six sessions delivered over three weeks. It is designed to enhance mindfulness and increase awareness of moment-to-moment experiences. Adults aged 18 years or older, fluent in English, will be recruited to participate in this randomised controlled trial. Participants will complete baseline questionnaires that will explore their levels of depressive, anxious and stress symptoms, alongside their levels of state and trait mindfulness. Subsequently, participants will be randomised to the iMindTime program or a waitlist control condition. Individuals assigned to the iMindTime program will complete ‘post-intervention’ testing after the program ends. Participants in the waitlist control will continue their usual activities and will complete ‘post-intervention’ testing after a three-week post-enrolment delay, after which they will be given access to iMindTime. It is hypothesised that the iMindTime program will decrease anxiety, depression and stress symptoms in comparison to usual activities.