ANZCTR search results

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

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31350 results sorted by trial registration date.
  • Investigating the efficacy of repetitive transcranial magnetic stimulation for people with Mal de Debarquement Syndrome

    Mal de Debarquement Syndrome is a rare condition whereby the person has continued perception of rocking and imbalance, usually occurring after a cruise, aircraft flight, or other sustained motion event. In many cases this continued perception of motion recedes after several hours or days. However in some cases persistent Mal de Debarquement Syndrome will last for years and decades. It has only recently received attention and very little scientific research has been conducted. However, the limited research to date has suggested that this condition is due to changes in excitability within the brain. The aim of this study is to investigate the efficacy of repetitive brain stimulation on people with Mal de Debarquement Syndrome. Individuals with this condition will receive eight sessions of repetitive brain stimulation, an established and safe technique, versus sham. Tests of brain excitability, balance testing, and self-reported perception of balance in daily activities will be undertaken prior to and at the end of the brain stimulation intervention, with self-reported perception of balance in daily activities followed up at six and eight weeks post intervention. It is hypothesised that those who received the real brain stimulation treatment will reduce symptoms in imbalance compared to those receiving sham. It is also hypothesised that brain excitability will reduce in those receiving the real treatment compared to sham treatment.

  • The effect of the Mathys Affinis Short Stem Total Shoulder Replacement on medium to long term pain and functional outcomes in patients with shoulder arthritis

    Shoulder arthritis can be extremely painful and debilitating and impact on a person's work and life. A solution in appropriate patients is the replace the ball and socket joint of the shoulder and so reduce pain and improve mobility. Historically these replacements have had a long stem in the humerus (long bone of the upper arm) and a new socket in the shoulder where the glenoid bone is. The developments in hip surgery with the replacement of the hip ball and socket, includes a stem which is now much shorter. It is postulated this results in less pain in the femur and may decrease the possibility of mid shaft fracture around the base of the stem. The development in shoulder prostheses has adopted the same concept. Short stem prostheses have been used for several years and this study is not experimental. This study will evaluate whether in this Australian population the short stem ceramic head has greater efficacy than the published studies of the long stem metal head prosthesis in total shoulder replacement. The five year prosthesis outcomes have been submitted for publication and a manuscript on the differences in outcomes between anatomic and reverse prostheses is in final draft. A second analysis will evaluate the efficacy of the Vitamin E enhanced crosslinked polyethylene glenoid component . A study of outcomes in patients 70 and above and below 70 in this cohort is in preparation.. The five year outcomes and the outcomes comparing the Anatomic shoulder replacement and reverse shoulder replacements of younger and older than 75 years have been published.

  • Can a new intensive model of aphasia rehabilitation achieve better outcomes than usual care with chronic aphasia resulting from stroke?

    Stroke is one of the leading causes of death and chronic disability in Australia. Chronic aphasia associated with stroke affects access to services, creates social isolation, depression and decreases quality of life. People with aphasia following a stroke experience a sudden loss of language ability but their intelligence is not affected. As a consequence of their communication disability, the person’s access to services is limited, adversely affecting rehabilitation outcomes and often resulting in increased rates of depression and social isolation, and decreased quality of life. Current rehabilitation for aphasia consists of long-term, infrequent and predominantly one-to-one therapy, the cost of which is taxing on an already-stretched health system. The proposed study will determine if the outcomes of an intensive, comprehensive and time-limited rehabilitation are better than current speech pathology intervention and evaluate the cost effectiveness of this model. Access to aphasia rehabilitation and meaningful outcomes for this under-served population will therefore be improved. UQ’s CCRE Aphasia Rehabilitation researchers have taken evidence from the bench to bedside by using principles of neuroplasticity from animal models to stroke recovery, and built an evidence base for the new intervention. Using implementation science we will determine the best methods to help translate new evidence into public policy and improve clinical practice. The overarching aim of this research is to determine the effectiveness of a new model of care for aphasia rehabilitation compared to usual care. There is a critical gap between the treatment that people with aphasia require to live successfully, and the limited services that are provided in most cases. Speech pathologists from our major Partner Organisation, Queensland Health (QH), have been seeking a new model of care to meet the National Clinical Guidelines of Stroke Management recommendation that aphasia therapy be delivered intensively (NSF, 2010; Wenke, 2012). At the same time, The University of Queensland (UQ) research team have developed and piloted an intensive, comprehensive, aphasia program, the Language Impairment and Functioning Therapy (LIFT) program. This program is the translation of decades of aphasia research into an intensive, comprehensive, time limited package and is the first of its kind in Australia. Intensive programs ensure that experience-dependent neuroplasticity occurs; comprehensive programs ensure that all clinical guidelines are adhered to and patients and their family have their needs met; and time-limited programs ensure costs are contained. This project seeks to develop a partnership whereby we work with our Partner Organisations (POs) to trial the LIFT program as a cost effective solution to closing the main evidence-practice gap in aphasia rehabilitation. Our partnership also recognises the nee d to translate the research into everyday health care. The pioneering research of implementation science brings potential solutions to overcoming the barriers to implementing intensive and comprehensive aphasia rehabilitation such that patients and health systems benefit from clinically effective and cost effective programs. Primary aim: 1) Assess the clinical effectiveness of LIFT compared to usual care; Secondary aims: 2) Assess the cost-effectiveness of LIFT compared to usual care; 3) Describe the barriers and enablers to uptake of LIFT by POs; 4) Develop a strategy for implementing LIFT into routine clinical practice. Hypothesis: Clinical and cost effectiveness outcomes for LIFT will be significantly better than usual care.

  • The INDIGO Study - A randomised controlled trial of physical activity with individual goal-setting and volunteer mentors to increase physical activity in insufficiently active older adults at risk of cognitive decline.

    AIM: The aim of this project is to determine whether a home-based six-month physical activity program with individual goal-setting and volunteer peer mentors can significantly increase physical activity levels in physically inactive older adults at risk of developing Alzheimer's Disease. HYPOTHESIS: that insufficiently active participants with subjective memory complaints or mild cognitive impairment who are randomised to the goal setting intervention with a mentor compared to participants randomised to a control group receiving standard education and peer contact will show a significantly greater increase in their PA at the end of the intervention. RESEARCH DESIGN: This study is a randomised, single-blind controlled trial. METHODS: Participants are individuals with subjective memory complaints or mild cognitive impairment and do not regularly engage in 60 minutes or more of moderate intensity leisure time physical activity. The primary outcome of interest is increase in physical activity as measured by a pedometer (steps/day). We are also collecting cognitive, personality, physical and clinical parameters. Participants are asked to provide a DNA sample via a saliva sample. Participants in both groups are asked to attend three workshops in six months. At the first workshop, they will meet a peer-age volunteer. These individuals are recruited and randomly assigned to provide either telephone mentoring or telephone contact. Volunteers are trained for each role and their self-confidence and level of physical activity are measured.

  • A randomised control trial assessing the effects of an adaptive attention training intervention in children with Intellectual Disabilities.

    The ability to concentrate and stay focused on a task, to switch attention between tasks, to inhibit impulsive responding, and to mentally hold and use information are critical skills for learning and academic outcomes. The development of these skills, collectively known as Executive Functions (EF), begins early in life and become progressively more robust from the preschool years onwards. Recent studies highlight that EF’s serve as predictors of literacy and numeracy scores in preschool through high school, facilitate social inclusion and peer relationships, and play an important role in maintaining mental health across the lifespan. Fundamental to EF skills is the construct of “attention”, a set of cognitive processes that gate learning more generally. Disruption to these essential processes can lead to increased levels of distractibility, impulsivity, forgetfulness and poor focus. In the case of children who are especially vulnerable to learning impairments because of an underlying intellectual disability (e.g. autism, Down Syndrome), attention difficulties will likely exacerbate an already compromised cognitive system by significantly impacting on a developing child’s ability to interact with the world and community around them. This will in turn reduce their capacity to engage in educational programs, and increase their already heightened risk of long-term behavioural and emotional problems. The high prevalence of Australian children and adolescents with intellectual disabilities, estimated at 650,000 (approximately 3% of the population) warrants an extensive and inclusive program of research that will investigate how core attention skills can be captured and strengthened in young children in order to maximise learning capacity from as early as possible in development. We propose to address this unmet need by delivering a novel attention training program that is targeted at primary school children with Intellectual disabilities. Our proposed project therefore hypothesises that the attention training program will improve inattentive behaviours in the classroom and home. As well as hypothesising that the attention training program will increase performance on other non-trained cognitive skills (working memory, math and literacy). Finally we hypothesise that the attention training program will result in sustained improvements in inattentive behaviours and performance on cognitive tasks 3 months after completion of the intervention.

  • Improving sexual health in men with prostate cancer through exercise and psychosexual therapies

    The study is evaluating whether exercise aids in the management of sexual dysfunction and explores if an integrated treatment model incorporating pharmacological, exercise and psychosexual therapies maximises improvement in sexual health in men with prostate cancer. Who is it for? You may be eligible to join if you are a male aged 18 years and over; have had prior and/or current treatment for prostate cancer including prostatectomy, radiotherapy or androgen deprivation therapy; and concerned about sexual health (as assessed by International Index of Erectile Functioning overall satisfaction score and/or Expanded Prostate Cancer Index Composite sexual bother score). Trial details. Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group (i.e. Exercise intervention group) will attend a 6 month physical exercise intervention program that involves resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 3 times per week in an exercise clinic. Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist. Participants in the second group (i.e. Exercise and psychosexual intervention group) will also undergo the exercise intervention described above as well as attend a single, 60 minute, one-on-one psycho-educational session with their exercise physiologist and receive a self-management kit that addresses psychological and sexual well-being. Participants in the third group (i.e. Usual care – delayed intervention group) will maintain usual care for 6 months before receiving the intervention – half will receive the intervention provided to the Exercise Group, and half will receive the intervention provided to the Exercise and Psychosexual Intervention Group.

  • Treating Comorbid Insomnia with Obstructive sleep Apnoea (COMISA) Study: A new treatment strategy for patients with combined insomnia and sleep apnoea.

    1. To conduct a randomized controlled trial of Cognitive Behaviour Therapy for insomnia (CBTi) in patients with co-morbid Obstructive sleep Apnoea (OSA) and insomnia to establish whether CBTi therapy improves Continuous Positive Airway Pressure (CPAP) adherence and sleep-related patient outcomes. 2. To explore whether insomnia and OSA are causally inter-related.

  • Investigating breathing training for lung cancer radiotherapy

    Purpose: This study is investigating whether the breathing training system can improve breathing regularity and reduce medical imaging errors in lung cancer patients undergoing radiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with lung cancer, for which you are scheduled to undergo radiation treatment. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will use the audiovisual (AV) biofeedback breathing training system during radiotherapy treatment if deemed helpful. AV biofeedback is an interactive, personalised and non-invasive breathing training system designed to assist the patient to breathe regularly. AV biofeedback is comprised of the real-time position management (RPM) system and a visual display (e.g. monitor, tablet computer), none of which are of any risk to the patient. The system is designed to be easily implemented into any treatment or imaging facilities. The patient views the tablet screen which displays their breathing pattern to them based on the real-time respiratory motion captured by the RPM system. Participants in the other group will receive treatment as usual, i.e. radiotherapy without breathing training. Participants will be monitored during treatment in order to determine whether AV biofeedback makes breathing more regular for imaging and treatment procedures during radiotherapy. Hypothesis: We hypothsise that AV biofeedback will significantly improve breathing regularity and reduce medical imaging errors for lung cancer patients undergoing imaging and treatment procedures during radiotherapy. Successful completion of this trial and positive testing of the primary hypothesis will give clinicians a simple tool to improve breathing regularity and reduce imaging and treatment errors for cancer radiotherapy patients.

  • Assessing the psychological and physiological efficacy of an exercise intervention in aged individuals: Is there a role for core-stability training?

    Age-related loss of skeletal muscle leads to reduced engagement in physical activity, impaired performance of activities of daily living and reduced quality of life. This may be associated with increased rates of depression and anxiety. We aim to explore a role for exercise in improving the multiple factors comprising quality of life in aged individuals.

  • Improving postural stability in people with Parkinson's disease: A randomised controlled trial

    [The primary purpose of this study is to examine whether an exercise program targeted at improving the strength and endurance of the trunk muscles has the potential to improve standing and walking balance in individuals with Parkinson’s disease. It is hypothesized that exercise will improve aspects of standing and walking stability in people with PD, particularly the smoothness of head and trunk motion.]

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