ANZCTR search results

Many people with stroke have walking and balance dysfunction. Sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) provided through a device called the Portable Neuromodulation Stimulator (PoNS) can stimulate regions in the brain that are important for balance and gait. This study will be a preliminary randomised controlled trial (RCT) of the PoNS combined with a structured task-specific rehabilitation program in stroke survivors undergoing inpatient rehabilitation.The study will be registered with the Therapeutic Goods Administration under the Clinical Trial Notification Scheme (device trial). Ten participants will be randomised to either a 2-week intensive balance and gait training program with a physiotherapist while using the PoNS (intervention), or to a 2-week intensive balance and gait training program with a physiotherapist only (control). Both the intervention and control programs will be conducted at the Royal Park Rehabilitation Centre, and will be additional to the patients' usual rehabilitation program. Training sessions will be tailored to the needs of each participant and comprise five main components: movement control, balance, gait, cognition and breathing and relaxation. Participants will be assessed on a range of outcome measures related to gait and balance, as well as self-perception of performance, depression, cognition and oculomotor function. Assessments will occur at baseline and post-intervention. The primary outcome measures will be the miniBEST Test, which assesses balance. This study will be the first systematic study of the PoNS in Australia, and will establish the safety and preliminary efficacy of the PoNS/training protocol. It will also provide data on which to base a sample size calculation for a future larger RCT.

Recreational drug use is becoming an increasing public health issue in our society. Methamphetamine usage in Australia has been described as an ‘epidemic’ that is ‘tearing our country apart’, and has recently been the subject of a Prime Ministerial National Ice Task Force. The average purity of methamphetamine seized by police in Western Australia has increased from 10% to 75% in just six years. In addition to this, there are a huge new range of synthetic drugs entering circulation, which are collectively termed novel psychoactive substances. These include many novel stimulants and hallucinogens, such as cathinones, NBOMe type drugs, and synthetic cannabinoid receptor antagonists. There were seven unrelated deaths in Australia over the 2015-2016 summer festival season related to synthetic drug use, as publicised in the ABC Four Corners investigation “Dying to Dance” (February 2016). This project is a novel study, based in the emergency department (ED), where patients suspected of being under the influence of recreational drugs have a single blood sample taken to identify the causative agent. The analysis will be undertaken by ChemCentre WA, with whom we have an established collaboration, using liquid chromatography-mass spectrometry analytical techniques. Prior to analysis, the sample is permanently de-identified. We aim to identify the agent (or agents), determine its concentration, and relate it to the clinical picture and complications. We will also compare the analytic result with what the patient believed they had taken. Where novel drugs are identified, repeat analytical work can be undertaken to aim to develop new assays and reference standards for future analysis. Samples will be stored frozen for five years to enable this work. We will be able to identify trends in recreational drug use in patients presenting to the ED, which is vitally important from a public health perspective. Should information of early interest to clinicians or the general public be identified, this would be released in the interest of public safety.

Increased sustainable “green” energy production has led to rapid expansion of wind farm facilities in Australia and world-wide. This has been associated with community complaints regarding noise emissions that include “infra-sound” (noise below average hearing threshold), and concerns that this may have negative effects on sleep and health. International studies so far remain inconclusive and none have included any direct measurements of sleep so it remains unclear how disturbing wind farm noise is to sleep. Ongoing uncertainty in this area remains a problem for communities close to wind farm facilities, government regulators, wind energy producers and the broader community. This project is specifically designed to address knowledge gaps concerning potential wind farm noise effects on sleep using the most sensitive techniques currently available for assessing sleep disturbance. The results of this study will help to inform the potential need for improved noise regulation and abatement strategies to minimise potential sleep and health impacts. This survey is the first part of a larger project, and is designed to identify people who report being affected by wind farm noise and others who do not, to be invited to participate in a home sleep and noise measurement study, or a later in-laboratory study at Flinders University. This survey is largely based on that developed by Health Canada to study wind farm effects on health and is being used with permission from the Health Canada study team, but has been modified based on input from Australian noise and sleep researchers, and community representatives from areas affected by wind farm or traffic noise. The aim of the survey is to identify 4 groups according to overnight noise exposure type and level of complaints. Individuals within these groups will be sequentially invited to participate in further field measurement and in-laboratory studies.

A strong push towards greener and more sustainable energy production has led to rapid expansion of wind farm facilities in Australia and world-wide. This has been associated with wide-spread complaints from neighbouring communities, particularly regarding noise emissions, including “infra-sound” (noise below average hearing threshold), and concerns that this may negatively impact on sleep and health. International studies so far remain inconclusive, particularly regarding noise effects on sleep. However, no studies so far have used physiological recording techniques necessary to properly investigate sleep. Consequently, this study is specifically designed to investigate windfarm noise effects on sleep using measurements normally used to diagnose sleep problems. This field study is the second part of a large three-part project designed to firmly establish what effect windfarm noise has on sleep compared to quiet sleeping conditions (control) and traffic noise, which is already known to disturb sleep and is therefore a useful condition to compare to (positive control). The overall aim of this study is assess self-reported (subjective) and direct objective measures of sleep quality in the natural home sleep/noise environment to examine relationships between noise, sleep disturbances and other factors.

Memory problems are among the most common cognitive difficulties after acquired brain injury (ABI), and can significantly compromise an individual’s ability to perform day-to-day tasks and quality of life. Computer-based training and compensatory approaches are two therapeutic approaches used to improve memory difficulties. The evidence to support the effectiveness of either approach is limited. This study will compare the efficacy of computer-based training versus compensatory memory rehabilitation approaches with regard to improving 1) memory and 2) performance in day-to-day tasks. Participants with ABI will be randomly allocated to participate in either six week of: (A) computer-based memory training, (B) compensatory memory rehabilitation (Memory Skills Group) or C) waitlist control group. This study will establish which approach to memory rehabilitation is most effective and which approach maximises daily functioning and quality of life for individuals with ABI.

Dementia-related wandering is very common and has been observed in 100% of ambulant people with dementia in RAC (Algase, Kupferschmid, Beel-Bates, & Beattie, 1997). Anecdotal evidence suggests that, when wandering occurs within safe limits, some benefits may be experienced such as physical activity, stimulation, the provision of meaningful activity and improved quality of life (J Dewing, 2006; Martino-Salzman, Blasch, Morris, & McNeal, 1991). However, evidence suggests that when wandering goes beyond safe limits, adverse outcomes for the person who wanders can be experienced (malnutrition and dehydration, sleep deprivation, increased potential for injury from falls and resident to resident violence, becoming lost, and death) (Algase, Beattie, & Son, 2004). For the person with dementia being cared for in RAC, unique problems associated with wandering are experienced. In the RAC setting the person with dementia who wanders can enter out of bounds areas, such as the bedroom of another resident, which can result in loss of privacy. Due to cognitive impairment, the person with dementia who has had their privacy invaded by a person who wanders may respond to the invasion with verbal and physical abuse, which exposes the person who wanders and their co-resident to increased risk of harm (Shinoda-Tagawa et al., 2004; Talerico, Evans, & Strumpf, 2002). The aspect of wandering resulting in these outcomes is known as boundary transgression (BT), defined as a dimension of wandering that takes the person who wanders to out of bounds or hazardous areas. InRAC when wandering takes the person with dementia into the private space of a co-resident, wandering could result in resident to resident violence, loss of privacy and increased agitation for the recipient of the intrusion, and social isolation for the person who wanders (MacAndrew, 2014). Staff and family members also reported that from their experience, wandering-related BT was very common in RAC, was difficult to manage as carers could not predict where and when a BT would occur and if it would be disruptive to others, and often resulted in physical and verbal abuse. Despite the known asdverse outcomes of wandering in RAC, in the absence of RCTs, there is not strong evidence to support the effectiveness of interventions, and there remains a dearth of evidence-based guidelines for the management of wandering in RAC . The aims of this pilot study are, in people with dementia living in residential aged care, to explore 1. the feasibility of using a supervised walking program delivered before peak ambulation periods 2. to examine if taking a person with severe dementia who wanders for a daily 30 minute walk for 3 weeks will: a. Reduce risky wandering including boundary transgression (BT); b. Improve quality of life (QoL), and sleep quality; c. Reduce agitation, falls and weight loss. A quasi-experimental study design will be used

Each year, 600 Australians are diagnosed with cerebral palsy with a $4 billion annual socioeconomic burden. One third never walk. The National Disability Insurance Scheme ranks early intervention to improve disability as its top priority. We have developed an early training intervention ("GAME" Goals Activity Motor Enrichment) based on the key neuroscience principles of activity dependent plasticity and enriched environments and on successful training interventions known to work in older children with cerebral palsy and adults post stroke. GAME is the only published protocol of an infant friendly early, intense, specific training intervention grounded in contemporary neuroscience, tested for safety and early efficacy, and is acceptable to parents. This new pragmatic, single blind randomised controlled trial (RCT) in 300 infants with cerebral palsy or at high risk of cerebral palsy aims to evaluate the effects of “GAME” versus traditional passive early intervention on gross and fine motor skills at two years of age. We will also evaluate the secondary outcomes of neuroplasticity on MRI, cognitive skills and quality of life. In this pragmatic trial, infants will receive experimental GAME training (once weekly therapist provided+ daily parent provided) versus control (traditional therapy alone). Both groups will be dose matched according to the standard National Disability Insurance Scheme early intervention funding package. Experimental and control treatments will continue until the infant’s 2nd birthday. Assessments will be carried out at baseline, prior to randomisation and at 1 and 2 years of age (corrected for prematurity). The expected clinical outcomes of our trial are that infants who received our intervention will have significant and lasting motor and cognitive gains that lessen the severity of their cerebral palsy and improve their quality of life.

The primary purpose of this trial is to evaluate the accuracy of PSMA-PET/CT scans for determining the stage of prostate cancer and planning treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with prostate cancer for which you have not yet received treatment, but it is planned that you will undergo surgery or radiotherapy. Study details: All participants enrolled in this trial will be randomly allocated (by chance) to receive either the conventional scans (CT + bone scan), or the PSMA-PET/CT scan which is being evaluated. All patients will cross-over to second-line DI (crossover to other arm) unless the disease status for distant metastases was positive (ie. not equivocal or negative) with >2 sites of disease demonstrated. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course. The accuracy of the scans will be determined by using follow-up information available up to 6 months after entering the study. If the scans showed abnormalities or your doctor has clinical suspicion of prostate cancer, the scans will be repeated at 6 months. In patients with normal PSMA PET/CT scans, follow-up data may be collected at 18 30, 42 and 54 months (the study will stop 3 years after randomisation of the last patient).

The study is evaluating the potential of a shared-care model of follow-up for survivors of colorectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more, have a confirmed diagnosis of colon or or rectal cancer at stage I-III, completed treatment with curative intent within the past 3-months at one of the participating sites and have a GP willing to participate in the study. Trial details: Participants in this trial are randomly (by chance) allocated to one of two groups. Participants in Group 1 will receive usual care according to current hospital practice. Participants in Group 2 will receive shared-care between specialist and general practitioner in which two routine hospital appointments will be replaced by GP appointments. In addition participants in Group 2 will receive a tailored survivorship care plan with care guidelines detailing information and recommendations about common concerns after treatment with additional support services information. Once the survivorship care plan is complete the patient will receive a written copy, with a copy provided to the patients preferred General Practitioner (GP). This is to ensure that the GP is familiar with the issues the patient is working on and can provide ongoing assistance as necessary. All participants will be asked to complete some questionnaires at the start of the study, and 6 and 12 months later in order to assess unmet needs, perceived experience of oncology care, satisfaction of the intervention and quality of life. Feasibility and cost-effectiveness of the two interventions will also be assessed.

The primary purpose of this study is to determine how the diagnosis of a bowel condition at colonoscopy/upper gastrointestinal condition at endoscopy, impacts quality of life, and whether this changes between diagnosis and one year later? We would also like to investigate the differences in the quality of life for those who have experienced surgery and/or neoadjuvant therapy, for colorectal, oesophageal or gastric cancer, within 3 years of treatment. Who is it for? Participants for this study will be people who have had a colonoscopy within the last two weeks, who have a diagnosis of one of the following at colonoscopy: (1) bowel cancer (stages I, II, III or IV), (2) advanced adenoma, (3) small non-advanced adenoma, (4) non-neoplastic findings (such as diverticular disease or haemorrhoids) or (5) no pathology detected (normal colon). People who have had an endoscopy within the last two weeks, who have a diagnosis for one of the following: (1) inflammation, (2) polyps, (3) oesophageal varices, (4) ulcers, (5) coeliac disease (6) Barrett’s oesophagus, (7) gastric cancer (stages I, II, III, IV), (8) oesophageal cancer (stages I, II, III, IV), or (9) no pathology detected, are also eligible. Also, for those who have had prior treatment for colorectal, oesophageal or gastric adenocarcinoma (stages I, II, III or IV) within the last 3 years. Study details: All study invitees will be sent via mail a study invitation letter and a questionnaire within two weeks after their colonoscopy appointment. The questionnaire contains questions about health conditions, health-related quality of life and well-being, attitudes toward managing health and other basic demographic questions (including age, education level and country of birth). A two week period will be allowed following the mail out of letters for return of completed questionnaires. If the questionnaire has not been returned during this time, then research staff will make telephone contact with the study invitees to follow-up and confirm their willingness or otherwise to participate in the study. Those who complete the questionnaire will be invited to complete the same questionnaire 12 months later. Individuals who have had prior treatment for colorectal, oesophageal or gastric cancer, within 3 years, will be sent the same information, an invitation letter, participant information sheet and consent and a once-only questionnaire. Follow-up telephone contact will also be initiated, should there be no response after two weeks. The invitees are given the option to withdraw from the offer of participation by telephone or withdrawal form, at any time. It is hoped that the findings of this trial will provide health related quality of life data for different bowel and upper gastrointestinal conditions and experiences in the Australian population. This can then be used in health economic modelling to assess the cost effectiveness of bowel cancer screening.