ANZCTR search results

A foot orthosis is an insert worn inside shoes to help realign the foot and ankle to reduce excessive movements that lead to pain, stress, and strain in the lower limb during functional tasks. The traditional process of orthotic fabrication is time consuming and labour intensive with the quality and effectiveness of the final product largely dependent on the skill level of the podiatrist fabricating the device. The use of computer aided design and manufacture (3D printing) has the potential to reduce the time and cost of orthotic manufacture, and reduce dependence on podiatrist's skill. Despite the reported benefits of the technology driven foot orthoses, the efficacy of 3D printed orthoses in changing gait kinematics, compared to traditionally made orthoses, has not been adequately investigated. This project will compare the immediate effects of traditionally manufactured orthoses and 3D printed orthoses in regards to: (1) manufacturing specifications (e.g. size and shape of the orthoses), (2) lower limb kinematics and kinetics, and (3) comfort levels in patients with clinically diagnosed heel pain. The results of this study will show how orthoses made using new technology compare with those made using traditional methods. Paired t-tests and repeated measures analysis of variance (ANOVA) will be used to examine the differences in outcome measures between conditions.

This randomised controlled trial seeks to investigate the adherence rates and efficacy of an internet-delivered program for repetitive negative thinking immediately following treatment and at 3-months follow-up, and compare outcomes for clinician-guided versus self-guided online program.

High blood pressure, also known as hypertension, is a disease where the blood inside the heart and blood vessels is pumped with more force than normal. This adds stress to these important tissues, increasing the chance of a heart attack, stroke and, as we age, heart failure. Hypertension affects one in three people in Australia, and is known as a ‘silent disease’ as it usually does not produce any symptoms until it might be too late. It is well known that our diet influences the risk to high blood pressure. While salt intake is associated with higher blood pressure, consumption of fruit, vegetables and other food rich in fibre is usually associated with lower blood pressure. New evidence from our laboratory has emerged that this may be due to the tiny microorganisms that live in our gut. While our bodies are incapable of digesting some types of fibre, they are fermented in gut, where they feed the community of ‘good’ bacteria. This results in the release of substances that can be detected in our blood and might be beneficial in lowering our blood pressure. The present study will expand our knowledge about the gut bacteria in the setting of normal and high blood pressure, to help us understand the types of bacteria present in hypertensive subjects and whether they could be contributing to the increase in blood pressure. This research has implications for cardiovascular health due to the relatively benign and cost effective nature of diet treatments. It will also inform on future intervention strategies and food guidelines.

This is an open-label single ascending dose (SAD), and randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study to evaluate the safety, PK and pharmacodynamic effects of oral doses of CST-2032 in healthy adult participants. In addition, an optional cohort of patients with Mild Cognitive Impairment (MCI) or Parkinson’s disease may be enrolled to evaluate the effects of a single dose of CST-2032. The study will additionally evaluate whether peripheral effects that may emerge with CST-2032 can be inhibited by CST-107. Up to 17 cohorts are planned for this study, with approximately 4-8 subjects per cohort following confirmation of study eligibility during the screening period.

This study will investigate the feasibility of using oestradiol vaginal tablets (Vagifem Low) for women on adjuvant aromatase inhibitors for breast cancer Who is it for? You may be eligible to join this study if you are female, aged 18 and above, have early breast cancer (stage I-III), on an aromatase inhibitor for at least 3 months and are experiencing genitourinary symtoms Study details All participants in this study receive estradiol vaginal pessaries (Vagifem Low) for 12 weeks (daily application for the first 14 days, then twice a week application for the next ten weeks). Feasibility/adherence to treatment will be assessed using a participant diary. This study will also assess symptom response, quality of life and sexual function using questionnaires and the effect of this treatment on blood levels of oestrogen. We hope this study will further medical knowledge and may improve treatment of genitourinary symptoms for women in the future.

It has been suggested that people with chronic obstructive pulmonary disease (COPD) have an aberrant immune response to influenza viruses, and as such, they may be less able to effectively mount an immune response to influenza vaccination. As little is known about the efficacy of influenza vaccine in COPD, this pilot study will examine the effect of two sequential doses of the seasonal influenza vaccination in those with COPD, and whether this higher vaccine dose is able to augment the immune response in COPD patients. Outcomes will focus on antibody response and the factors that predict an effective antibody response to the vaccine.

This study is assessing whether a cellphone text based reminder service will improve the likelihood of participants carrying out their pelvic floor muscle exercises at home to lessen the chance of leaking urine after surgery for removal of the prostate due to prostate cancer. Who is it for? You may be eligible for this study if you are a male aged 30 years or older, who has been diagnosed with prostate cancer that is eligible for surgery to remove your prostate, and you have access to a mobile phone. Study details Participants in this study will be randomly assigned to one of two groups. The first group will receive daily text message reminders to complete their prescribed pelvic floor exercises. The text messages will be sent for up to 2 weeks prior to their prostate removal surgery, and will then be sent daily starting 2 weeks after their surgery for up to 3 months after surgery. The second group will receive the same text message reminder only once 2 weeks before their surgery, then once 2 weeks after their surgery and then once every 4 weeks for up to 3 months after surgery. All participants will be asked to complete a study diary to record whether they have completed their pelvic floor exercises each day, as well as to note how many incontinence pads they used each day after their surgery. Participants will also be asked to complete a study questionnaire at set timepoints, which will ask you about any incontinence you have experienced after surgery, and for your thoughts on the text message reminder service. It is hoped this research will determine whether text message reminders about completing pelvic floor exercises regularly will lead to improved health outcomes for prostate cancer patients by helping to reduce the incidence of post-prostate removal surgery incontinence.

The aim of this study is to examine the efficacy of an ICBT-P program targeting perfectionism, in a sample of adolescents displaying elevated eating disorder symptoms as an indicated prevention study. It is hypothesised that after completion of the online Overcoming Perfectionism intervention, participants will report significantly fewer eating disorder and perfectionism symptoms than at pre-intervention. It is hypothesised that those in the ICBT-P program will score significantly lower on measures of perfectionism and eating disorder psychopathology when compared to a waitlist control. It is predicted that these results will be maintained at three month and six month follow up.

In people with COPD; (i) what are the issues related to downloading and using the Step app and, (ii) what is the effect of a single education session on competency to download and use the Step app. Methodology: Participants with a diagnosis of COPD own a smartphone and are literate in English. Participant will be involved in completing three assessments and one education session (over two appointments). During the first 90-minute appointment, all participants will do a 0 – 10 visual analogue scale (VAS) to rate their perceived confidence in completing the tasks, this will be done four times over the two appointments.(before and after the assessment package or tasks.). The assessment package is described below. Thereafter, participants will be randomly allocated to one of two groups; experimental or control. Those in the experimental group will receive a 30 minute one-on-one education session on the use of the smartphone and Step app and those in the control groups will receive a 30-minute one-on-one education session on the nature of COPD and way in which rehabilitation produces benefits. Immediately following completion of the education session, all participants will repeat the assessment package. The PhD student will conduct all the education sessions for the participants. During the second appointment, conducted one month later, participants will complete a third (and final) administration of the assessment package. This appointment will be approximately one hour in duration. Assessment package: the PhD student will ask the participant to complete a set of predefined tasks, such as downloading the app, opening the app, using the app, refreshing the screen and closing the app. Each task will be broken down into sub-components. The participant will be permitted to move to the next task only once they meet ‘completion criteria’. On completion of each task the PhD student will; (i) record whether or not each sub-component was completed accurately, (ii) record the number of attempts made to complete the sub-component, (iii) record the time it took for the participant to reach completion criteria, (iv) ask the participant to rate their confidence with completing task on a 0 – 10 visual analogue scale (VAS). This will be video-recorded with only the hands of the participant in the frame with no identifying features.

Intranasal N-Acetylcysteine (NAC) is registered within Australia, but not for use in mild traumatic brain injury (concussion). This trial aims to determine if a phase 1 trial in healthy volunteers is feasible, by testing if NAC, via nose-to-brain delivery, effectively targets 3 regions of interest in the brain. The results from this trial will be used to inform a phase 1 trial in healthy volunteers.