ANZCTR search results

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

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33070 results sorted by trial registration date.
  • Improving the mental health of stroke survivors and carers: An evaluation of the Stroke and Carer Optimal Health Program (SCOHP)

    Stroke is a disease with severe consequences for the survivor and the unexpected carer. Carers experience tremendous changes and challenges from role reversal to financial struggle and subsequent increased burden, low mood, and poor overall health. In Australia, there are approximately 60,000 new strokes per year; a decrease in stroke mortality as a result of improvements in medical and surgical management mean people are living longer with the residues of stroke, and that carers increasingly face long-term burden. Eighty percent of individuals who experience stroke return home with varying degrees of neurological, behavioural and psychological symptoms. At home, they often rely on informal carers for their physical and emotional support. Previous psychosocial interventions to support informal carers of stroke survivors have shown promising results; however none have sought to integrate carer interventions with care coordination. To address this, the Stroke and Carer Optimal Health Program (SCOHP) has combined a 8-week individualised Collaborative Therapy with a booster session 1 month later. This research will assess the feasibility and cost-effectiveness of improving the mental and physical health, social connectedness and health service utilisation of the carers of stroke as well as stroke survivors. This model will be designed with the intention of being readily adapted and applied in the context of other physical and also mental diseases. The findings of this randomised control trial will investigate the impact of SCOHP on increasing carer and stroke survivor self-efficacy and quality of life.

  • Aqueous vs Alcoholic Antisepsis with Chlorhexidine for skin Excisions - The AVALANCHE trial.

    Preoperative cleansing of the skin with antiseptic preparations at the site of surgical excisions (preoperative skin antisepsis) is common practice before every surgery worldwide, and aims to reduce surgical site infection. However, in most contexts, no definitive scientific consensus exists regarding which preoperative skin antiseptic preparations are most effective. This randomised controlled trial aims to close an existing gap in the evidence base surrounding optimal preoperative skin antisepsis before clean surgery - a practice most general practitioners carry out several times per week when they perform skin excisions. It is currently suspected on the basis of incomplete and methodologically inconsistent evidence that alcoholic antiseptic preparations are likely to be more effective than aqueous preparations for the prevention of surgical site infection (SSI) after clean surgery. This study aims to find definitive proof for this theory by determining whether there is a difference in the incidence of SSI after minor skin excisions in general practice when alcoholic chlorhexidine is used for preoperative skin antisepsis by comparison to when aqueous chlorhexidine is used. It is hypothesised that use of alcoholic chlorhexidine will reduce SSI by comparison to aqueous chlorhexidine. To implement this study, multiple general practices in the Mackay region which perform large numbers of skin excisions each year will be recruited. Consecutive patients over the age of 18 presenting to participating practices will be asked to participate in the trial and those that agree to partake will be randomised by a computer-generated random number table to receive preoperative skin antisepsis with either 0.5% chlorhexidine dissolved in 70% alcohol or 0.5% chlorhexidine dissolved in water. All other techniques and materials used for both preoperative skin antisepsis and the skin excision itself, as well as all aspects of post-operative care, will be kept constant between the two groups, and will align with a pre-specified surgical and wound protocol. Following their excision, patients will be assessed for the presence or absence of SSI by their treating doctor or nurse when they present for removal of sutures, or at any other time if they re-present due to suspicion of SSI or for any other reason. Rates of SSI will then be recorded, calculated and compared between the two groups using the statistical analysis software SPSS to determine if there is a significant difference in effectiveness between aqueous and alcoholic chlorhexidine. Hopefully the results of this study will help to provide direction to doctors regularly carrying out clean surgery, who at present have little definitive evidence to guide their choice of preoperative skin antiseptic preparations. Looking further, if a difference is found between aqueous and alcoholic chlorhexidine, we would aim for this research to impact current guidelines on preoperative skin antisepsis and evoke behaviour change from doctors and nurses which leads to a reduction in SSI rates in general practice.

  • Methylphenidate in Adults with Severe Traumatic brain injury for the Enhancement of Recovery (MASTER)

    The research aims to learn more about the potential benefits of methylphenidate (Ritalin) as people recover from traumatic brain injury. Ritalin is a stimulant medication, most-widely known for its use in children with Attention Deficit Hyperactivity Disorder. It works by increasing the concentrations of certain neurotransmitters within the brain, especially those involved in attentional processes. Past studies have shown that methylphenidate has been effective in patients with a traumatic brain injury in improving attention. This study looks at whether it not only improves attention but also day to day function and sense of well-being after three months.

  • Does Dynamic Tape (trademark) change hip muscle activity and function in healthy females during walking and running?

    Abnormal hip biomechanics during walking and running are considered a risk factor for the development of lower limb musculoskeletal conditions such as patellofemoral pain and non-contact anterior cruciate ligament injuries. These injuries have a higher reported incidence in females which may be attributed, in part, to their relatively higher hip adduction and knee abduction angles than male counterparts. Altered recruitment of the muscles controlling hip abduction and femoral rotation may also contribute, potentially causing dysfunction further down the kinetic chain at the knee, and foot/ankle and predisposing to injury. Elastic taping techniques are a relatively recent and popular modality used by clinicians to modify hip position and motion during gait. Unlike rigid therapeutic tapes, these new elastic tapes propose to have viscoelastic properties which provide mechanical assistance to joint motion and muscle activity, hence enabling the restoration of normal joint kinematics. No scientific study however has evaluated the effectiveness of elastic taping at the hip joint. This project aims to evaluate the effects of a novel elastic tape (Dynamic Tape (trademark)) on lower limb kinematics and hip muscle recruitment in healthy females. We hypothesize that the experimental elastic tape will produce greater change in lower limb joint range of motion and hip muscle recruitment when compared with a placebo elastic tape and no-tape control condition.

  • Transfer effects of step training on stepping performance in untrained directions among older adults

    Step training has been recommended as a fall prevention strategy. However, it is possible that the repetitive step training in the forward and lateral direction might have negative effects for stepping ability in the diagonal (untrained) direction. Participants (45 adults 65+ years) will be asked to practice pre-administered exercise for 15 minutes in a single session. Baseline and post-intervention assessments will involve tests of stepping performance.

  • The effect of an outpatient exercise training rehabilitation programme on haemodynamics and cardiac magnetic resonance parameters of right ventricular function in patients with pulmonary arterial hypertension: the ExPAH trial.

    This study looks at the effect of an outpatient exercise program on how the heart functions, using the latest technology (cardiac magnetic resonance imaging) and more established indicators of prognosis measured by right heart catheterisation. It also examines the effect of exercise on patient endurance and quality of life. The results of this study will have important widespread implications for the outpatient treatment of PAH, providing guidance regarding the optimal format of exercise in patients with PAH.

  • Evaluation of the impact of surgical repair of rib fractures compared to non surgical management of rib fractures on pain and quality of life.

    The optimal management of patients with fractured ribs who are not ventilator dependent has still not been determined. Although various studies suggest improvements in both short and long term function in patients who are treated by operative stabilization, there is not enough good evidence to advise management practices. However, the evidence available suggests that significant improvements in patient management and long term outcomes could be achieved by surgical fixation of ribs in these patients. A definitive answer will only be achieved by a prospective trial examining the short-term and longer term outcomes for patients treated by operative stabilization of their rib fractures This study aims to assess early and late outcomes in patients with multiple painful displaced fractured ribs with and without operative fixation.

  • A study investigating movement, pain and activity in failed back surgery patients undergoing spinal cord stimulation.

    Spinal cord stimulation (SCS) is a treatment option for cases of persistent pain, refractory to other forms of treatment. The first wave of studies produced generally favourable results, with reductions in pain ranging from 49% (Alo, Redko & Charnov, 2002), 55% (Villavicencio et al., 2000) to 74% (Dario et al., 2001). Since this time, a systematic review of 63 publications, predominantly comprised of case series, found that 58% of patients achieved clinically meaningful pain relief at two year follow up (Taylor et al., 2014). Taking this finding at face-value, it appears approximately 42% of chronic pain patients under-going SCS do not achieve significant pain relief. However, among this population, there is presently a scarcity of research to examine change to mobility and function. This is important, as it is plausible that the analgesic effects of SCS could be mitigated by patients increasing their mobility; a clinically important outcome in and of itself. To the author’s knowledge, objective measures of movement pre and post SCS have not been reported in the literature. Thus, the key aim of the present clinical trial is to objectively assess change to motion and mobility in patients with persistent pain following SCS, and its relationship to change in pain levels. On this basis, the following hypotheses were generated: 1. Movement and pain will correlate in participants with FBSS undergoing SCS trial and implantation 2. Activity and the ODI index will correlate in participants with FBSS undergoing SCS trial and implantation.

  • Feasibility of performing measurements of airway collapse during tonsillectomy surgery in children.

    Obstructive sleep apnoea (OSA) is a condition involving repeated episodes of partial or complete blockage of the airway during sleep. Learning difficulties, behavioural problems as well as bed-wetting, sleep-walking, retarded growth, other hormonal and metabolic problems and even failure to thrive can be related to sleep apnoea. Children diagnosed with OSA usually undergo surgical removal of the tonsils and adenoids. However, there is a high rate of complications with approximately 50% of the children suffering from minor or major breathing problems during and/or after surgery requiring specialised care. Additionally, the younger the children are, the higher the risk of breathing problems, which have a potential for serious harm to their health. The impact on the healthcare system is significant; the number of unplanned admissions necessitating specialised treatment with prolonged hospital stays increases causing delays on theatre lists. This leads to potential cancellations of other children due to the lack of theatre time and consequently increases the waitlist time. Currently the pre-operative assessment by the ENT surgeon determines whether the child will be managed as a day case or a ward patient. In case of the latter, it is further distinguished if the child gets normal ward care, specialised ward care or whether an admission to the intensive care unit is required. If the child has not been sent to the preoperative anaesthetic clinic (which is the case for the majority of children), the anaesthetist on the day of surgery might need to organise more specialised care if he/she does not agree with the care pre-organised, which may lead again to cancellations. Currently, preoperative assessment relies heavily on the surgeons and the anaesthetists’ pre-operative diagnosis. It usually involves using a clinical questionnaire that relies mostly on parental observation and interpretation of symptoms to accurately identify the presence of OSA and grade its severity accordingly. Once the grade of OSA has been established, the risk of perioperative respiratory complications can be better established and preventative strategies can be implemented where deemed necessary. However the rate of complication and unplanned admissions remain high. This is due to the grading of OSA being impacted by the high variability in the answers to the clinical questionnaire; different parents interpret the same symptoms differently and thus introduce a high bias in the OSA grading. A more appropriate approach to diagnosis and grading OSA with a much higher degree of accuracy would be the use of a scientific marker that can easily, quickly and safely be measured at the point of care. It is well known and has been shown in the literature that children with OSA have upper airways that are more prone to collapse during sleep and thus anaesthesia. Thus measuring the propensity of upper airway collapse may provide the treating team with more accurate physiological data to grade OSA and consequently narrow down the variability in the estimated probability of perioperative respiratory adverse events. Our team of respiratory and sleep physiology experts have developed and trialled a quick, safe and easy technique to measurement the propensity of upper airway collapsibility in adults and with this study we are aiming to identify whether this technique can be used in everyday clinical practice during peri-operative management to screen children with OSA who are at a higher risk of perioperative respiratory adverse events (PRAE).

  • Research study of a new miniaturized (reduced size) left-ventricular assist device called “Miniaturized Ventricular Assist Device“(MVAD 'Registered Trademark' System), which is being developed for the treatment of advanced heart failure.

    This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare 'Registered Trademark' Miniaturized Ventricular Assist Device (MVAD 'Registered Trademark' Pump) system over 24 months in subjects with advanced heart failure

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