ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31247 results sorted by trial registration date.
  • Biofeedback gait training in stroke patients.

    The aim of this project is to demonstrate the effectiveness of using visual feedback to increase toe clearance during walking in people with stroke. This new intervention has the potential to improve walking safety and reduce the risk of trips and falls. One important gait variable in these types of trips is minimum toe clearance (MTC). Reduced MTC can increase the risk of tripping. 150 participants will be required to attend 16 sessions (two baseline assessments (one clinical assessment conducted by a Physiotherapist and practice walking on the treadmill, the other is biomechanical assessment to determine MTC), 10 gait training only, and 4 post-training assessments (one after completing the final training, and then 1 month, 3 months and 6 months post-training follow up session). Half of the participants (n=75) will be randomly assigned to an Experimental group who will receive treadmill-based gait training with toe clearance feedback and half will comprise a Control group who will undertake assessment and training trials exactly as the Experimental group but will NOT receive the corrective real time feedback. The ten training sessions will occur over a 5-6 week period, with at least one rest day between sessions. Six assessment sessions will be about 90 minutes duration. The training sessions will take approximately 60 minutes. At all sessions, participants will be required to walk on a treadmill for up to 10 minutes. They will wear a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, data from markers will provide ‘real time’ feedback to Experimental participants about their affected leg toe clearance during the swing phase of walking. Using this information, participants will be asked to modify their walking pattern to match a “target” increased toe clearance. Feedback will be provided continuously for the first 6 sessions and then progressively reduced (faded) across the last 4 sessions.

  • Wellbeing Intervention for Chronic Kidney Disease (WICKD): A Trial of the Aboriginal and Islander Mental Health Initiative (AIMhi) Stay Strong App.

    Aboriginal and Torres Strait Islander people with chronic kidney disease (CKD) may suffer distress and poor mental health from living with a chronic illness, travelling away from family and country to receive treatment, poor access to housing and accommodation and big changes to their lifestyle. The WICKD Study is a randomised controlled trial to test the effectiveness of a culturally-adapted, electronic mental health intervention (i.e. Motivational Care Planning (MCP) using the AIMhi Stay Strong App) in improving psychological distress, depressive symptoms and quality of life among Indigenous Australians on haemodialysis in the NT. People with ESKD on dialysis are a group in which distress is likely to be unacceptably high, yet relatively untreated. The highly structured MCP intervention can be used by a wide range of healthcare workers and provides a high-fidelity treatment that can be integrated into a primary health care or chronic disease management setting. This coordinated approach, combining mental health prevention and intervention within a chronic disease setting could substantially reduce the impact of mental illness among Indigenous people with CKD and may have broad applicability across CKD and other chronic disease populations, both Indigenous and non-Indigenous. Demonstrating the effectiveness of this intervention will provide evidence for best practice intervention for managing distress for people on dialysis and facilitate integration of treatment for psychological distress within a chronic disease management setting. HYPOTHESES We hypothesize that: Compared with the control interventions, MCP using the AIMhi Stay Strong App will elicit greater reductions in psychological distress as measured by the Kessler distress scale (K10) at 3 months post-baseline. 1. Compared with the control interventions, MCP using the AIMhi Stay Strong App will elicit: a. Greater reductions in severity of depressive symptoms as measured by the Indigenous adapted Patient Health Questionnaire (PHQ-9) at 3 months post-baseline. b. Improved QoL as measured by the EQ-5D (5 level) at 3 months post-baseline. c. Greater adherence to treatment as measured by higher attendance at scheduled dialysis sessions and fewer hospitalisations at 3 months post-baseline 2. Similar improvements from baseline on psychological distress, depressive symptoms, QoL and adherence to dialysis will be seen in the three conditions at 6 months post-baseline, when all will have received the MCP intervention. 3. Compared with the control interventions, MCP using the AIMhi Stay Strong App will be cost effective, from the health service provider perspective, as measured by the cost per quality-adjusted life year (QALY) gained, and the cost per additional patient achieving a clinically meaningful improvement in the K10 at 3 months and 6 months.

  • Dispensing study to assess the visual performance of optimised prototype contact lenses

    This study aims to find out the visual performance of different prototype contact lenses compared to commercially available contact lenses. The prototype lenses use different optical designs to standard contact lenses by increasing depth-of-focus, and may offer an improved wearing experience.

  • Is there educational value in providing individualised feedback in addition to generic feedback to online course participants?

    This study aims to assess the effect of providing individualised feedback in addition to generic feedback compared to generic feedback alone on learning outcomes of a web-based educational course related to falls prevention.

  • Effects of early motivational interviewing on post-stroke depressive symptoms: a pilot randomised controlled trial of the Good Mood Intervention program.

    Depression is a frequent consequence of stroke that affects recovery adversely and can lead to greater mortality; however, it is often undetected or treated inadequately. While antidepressants can be used to treat post-stroke depression (PSD), they increase the risk of side-effects which complicate recovery. This randomised controlled trial evaluates a new brief intervention, the Good Mood Intervention program. The aim of the study is to investigate if motivational interviewing (MI) improves patients’ mood post-stroke. It will be conducted at the Stroke Unit, Western Hospital, Melbourne and will recruit inpatients with acute stroke.

  • Safety of Plasmodium falciparum K13 isolate in healthy participants.

    This study will evaluate the safety and infectivity of a P. falciparum K13 artemisinin-resistant malaria parasite in healthy participants using the IBSM model. P. falciparum K13 was isolated from a person with malaria infection and is resistant to the antimalarial drug artemisinin and related drugs such as artesunate. We expect that artesunate treatment will kill the K13 parasites, although at a slower rate compared to drug sensitive isolates. In addition, the P. falciparum K13 isolate retains sensitivity to other antimalarial drugs including piperaquine and atovaquone. Participants will be treated with artesunate to characterise the parasite clearance profile of P. falciparum K13 in response to artesunate .If artesunate does not clear parasitaemia participants will be administered piperaquine, which is known to be active against P. falciparum K13 (as a single oral dose of Eurartesim ‘Registered Trademark’ piperaquine tetraphosphate/dihydroartemisinin tablets) The availability of a P. falciparum artemisinin-resistant isolate in the IBSM model will allow investigation of the efficacy of novel antimalarial drug candidates in clearance of artemisinin-resistant P. falciparum, which is a growing problem in South-East Asia and threatens to spread across the world.

  • Gastrointestinal mechanisms underlying glucose lowering by metformin in type 2 diabetes

    Emerging evidence suggests that the anti-diabetic action of metformin resides primarily in the gut. Metformin has been shown to increase plasma concentrations of GLP-1 which are released from enteroendocrine L-cells located in the ileum and colon. GLP-1 has the capacity to restore blood glucose homeostasis in type 2 diabetes via pleiotropic actions including stimulation of insulin secretion and suppression of glucagon in a glucose-dependent manner, slowing of gastric emptying, and inhibition of hepatic glucose production and energy intake. Hence, the region of the gut exposed to metformin may be an important determinant of the lowering of blood glucose in type 2 diabetes. In this trial, we wish to investigate whether administration of metformin into the 'distal small intestine' (190cm beyond the pylorus) results in a lower glycaemic response to oral glucose when compared with administration into the 'proximal small intestine' (10cm beyond the pylorus) and evaluate the associated changes in plasma GLP-1, insulin, glucagon, 3OMG, lactate and metformin and rate of gastric emptying in patients with type 2 diabetes. There is increasing evidence that the incretin system has important cardiovascular effects and hence, we also wish to assess the changes in blood pressure and heart rate, in response to oral glucose, in the presence and absence of "proximal" or "distal" metformin.

  • Novel markers of diabetes related kidney complications.

  • The effects of spinal cord stimulation on nerve function in low back pain

    Spinal cord stimulation (SCS) has been employed for the management of chronic pain for over 50 years. Over this time SCS has become a well-established mode of treatment for neuropathic pain. Until recently most success with SCS has been obtained with pain involving the limbs (e.g. CRPS, sciatica, ischaemic limb pain and peripheral neuropathy). Relief of axial back pain has been more difficult to achieve. In response to problems associated with SCS (stimulation variance with body position, MRI lead incompatibility, difficulties covering certain pain sites) a wide range of device options have developed. As a result the number of companies manufacturing implantable spinal cord stimulators continues to increase with each company claiming specific benefits for their device range. The most dramatic recent change has been the introduction of high frequency (HF) SCS (500 Hz to 10,000 Hz). Early work on HF SCS demonstrated potential benefits on axial back pain. The additional feature of “paraesthesia-free” stimulation to avoid the need for paraesthesias required by the more conventional tonic low frequency (LF) SCS (<100Hz) has made this form of stimulation more attractive. Paraesthesias have the potential for discomfort particularly with changes in position (standing to lying). In 2015, a landmark prospective randomised trial was published (Kapural et al) reporting superiority of HF SCS over LF SCS for axial back pain. While the mechanisms of action for conventional SCS are still being investigated, even less is known about HF stimulation. Given the positive results reported by Kapural et al it is likely that the use of HF SCS will dramatically increase. While no definitive evidence of neural damage has been found on clinical examination concern has been raised in animal studies about the potential for long-term neural changes with HF SCS. In addition certain patient subpopulations may be more vulnerable to stimulation induced changes in neural function particularly those with spinal canal stenosis (personal communication). Given Kapural et al has only recently been published consensus regarding the long-term use of HF SCS in axial low back pain is yet to be reached. This pilot study will monitor changes in neural function associated with propriety LF (<100Hz) and HF (10kHz) SCS implantation in people with chronic low back pain over twelve months. The project will inform the development of a full-scale trial. The Global Burden of Disease study now ranks low back pain (LBP) as the number one cause of disability in Australasia. Three million Australians now have long-term disability due to chronic LBP, costing more than $14 billion each year. As a result of a recent successful high profile multi-centre trial HF SCS implantation for chronic LBP is likely to increase. It is crucial therefore to obtain long-term safety data on this treatment to better inform patient selection and future cost benefit analyses.

  • Evidence-based programs to improve the wellbeing of people with dementia and their carers: Implementing the Care of Older People in their Environments (COPE) program in the Australian Health Context

    COPE is an evidence -based non-pharmacological program developed by Professor Laura Gitlin from John Hopkins University. COPE is proven effective in reducing dependency and engagement of the person with dementia, and in improving carer wellbeing in a randomised trial in the US. The program uses occupational therapy skills with complimentary nursing skills, centring the needs of both the carer and the person with dementia. This implementation research project aims to integrate the COPE intervention within existing health and aged care systems in Australia. The project will examine facilitators and barriers at therapist, organisation and policy levels, explore funding models and building in features of sustainability. There will be a process evaluation (interviews, focus groups and observation) and a cost-benefit evaluation (questionnaires and data collection forms) included in the research project. The final output for the project will be an Implementation Strategies Document to influence policy and address how COPE can be rolled out wide-scale.

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