ANZCTR search results

In young patients, traumatic injury to the cervical spinal cord generally results from vertebral fracture and dislocation of vertebra, with injury to the spinal cord occurring not just at the time of impact, but also from compression of the spinal cord as a consequence of the displaced vertebra. Traumatic central cord syndrome differs from traumatic SCI in that the general mechanism is hyper-extension of the spine, causing acute severe canal restriction, in a patient with pre-existing narrowing of the cervical canal. Compression of the spinal cord as a result of canal stenosis and cord swelling usually occurs soon after injury. Animal and preliminary human data demonstrate that urgent relief of compression appears to greatly improve outcome. However, urgent decompression in humans is difficult to achieve because of the time occupied by transportation, investigation, and stabilisation of the patient as well as the organisation of surgery. Pre-clinical data demonstrate that hypothermia can suspend the progressive damage caused to the spinal cord by compression thereby allowing decompressive surgery to be performed in a clinically achievable time frame (Batchelor et al. 2010). The primary purpose of the ICED study is to determine whether the combination of hypothermia and early decompression is able to improve outcomes in patients with severe spinal cord injuries of the neck. Selected patients will be cooled by paramedics or emergency physicians immediately following injury and then rapidly transported to theatre to undergo surgical decompression and stabilisation of the spinal cord. Cooling will be maintained for 24 hours and then patients will be slowly rewarmed and monitored over the next 72 hours. The ICED safety and feasibility study will determine whether it is possible to cool patients with spinal cord injuries resulting from vertebral trauma in the neck in the first hours after injury. This study will also determine whether it is feasible to operate on patients very early after injury. As well as determining whether these interventions can be performed, the incidence and severity of complications will be monitored to determine whether these interventions are safe.

This study seeks to determine if incorporating sounds into mindfulness programmes will serve as viable alternatives in enhancing mindfulness skills acquisition, emotional flexibility, and psychological wellbeing, compared to the breath and body, in participants with a history of depression or anxiety. Participants will first be screened in a pre-intervention interview (individually conducted) – using the Structured Clinical Interview for DSM-5 (SCID-5), alongside obtaining demographic information such as age, gender, meditation experience, and music experience. From the SCID-5, any participants with severe presentations will be excluded from the study, but will be provided with referral information as necessary. All participants will be informed about the outcome of the SCID-5, within 1-2 weeks of the interview. Suitable participants will then go through a pre-group session (individually conducted), where they will fill in the Five Facet Mindfulness Questionnaire (FFMQ), Brief Resilience Scale (BRS), and Depression Anxiety Stress Scale-21 (DASS-21). They will also have their heart rate variability taken during the pre-group session. Participants are then randomly allocated (using simple randomisation) to two independent conditions - “active control” (ie. mindfulness activities using the breath and body as attentional targets as per other mindfulness oriented programmes), and “sounds” (mindfulness activities incorporating various sounds as external attentional targets). All participants are blinded to the random allocation process. Following which, participants will attend eight weekly mindfulness sessions, each lasting one hour each (group settings of up to 8 people). Participants in the “active control” condition will first engage in two weeks of mindfulness familiarisation sessions, followed by six weeks of various guided mindfulness activities using the breath and its accompanying bodily sensations as attentional targets. Participants in the “sounds” condition will engage in two weeks of mindfulness familiarisation sessions, followed by six weeks of various guided mindfulness activities accompanied by unique soundtracks lasting 5-8 minutes long. Each soundtrack is only played once throughout the duration of the intervention. During the intervention, regardless of the condition they are in, all participants fill in an Outcome Rating Scale (ORS) at the start of every session; the FFMQ, BRS, DASS-21 and a session rating questionnaire at the end of every session. All participants will also be given session handouts at the end of each session. After the intervention, all participants go through a post-group session (conducted individually), which is identical to that of the pre-group session. Participants will be given opportunities to provide feedback regarding the study, during the post-group session.

Despite the fact that Polymyalgia Rheumatica (PMR) is the most common inflammatory rheumatic disease of the elderly, it is under-researched and poorly understood. With no diagnostic tests available, diagnosis is dependent upon a history of muscle pain and stiffness in the shoulder and hip regions, combined with raised inflammation levels in the blood. Treatment consists of prednisolone (commonly referred to as “cortisone”) prescribed in a “one size fits all” approach that lasts ~12 months in duration. However, the way in which PMR patients’ symptoms respond is very variable; some improve almost overnight, whilst other individuals require higher doses for much longer periods of time. Unfortunately, such long-term prednisolone use can result in many complications including osteoporosis, weight gain, high blood pressure and diabetes. This project therefore aims to identify the characteristics of PMR patients that have failed standard cortisone treatment and remain on long-term prednisolone. In addition, prednisolone-related treatment complications will be documented.

The purpose of the study is to determine if a planned Patient-Centred Family Meeting held soon after a patient’s admission to an inpatient palliative care unit, is feasible and acceptable to the patient, their family and clinicians. In addition, the study seeks to better understand the benefits and burden of participating in Patient-Centred Family Meetings from the perspective of the patient, family and clinician and to assess if the outcome measures that have been selected are suitable and feasible from the patient and family perspective. The primary hypothesis is that conducting a planned Patient-Centred Family Meeting soon after admission to a specialist inpatient palliative care unit is feasible and acceptable to patients, families and clinicians. The Patient-Centred Family Meeting will be the intervention in one of three specialist palliative care facilities. Two other facilities will be the control sites where standard care, that may include a family meeting, is provided and observed. Inpatients aged over 18 years with a terminal illness newly admitted to one of the two palliative care facilities who are able to consent and have a family member willing to participate will be included. A minimum of 10 patients and a minimum of an equivalent number of family members will be recruited for the intervention and control arms of the study.. More than one family member may be included in recruitment. At the intervention site, outcome measures will assess patient and family distress and satisfaction with quality of life at end-of-life, before and after the Patient-Centred Family Meeting. Interviews with patients and families and focus groups or individual interviews with clinicians will be undertaken after the Patient-Centred Family Meeting to understand the experience of these participants concerning the intervention. Focus groups or individual interviews with clinicians will also be undertaken at the control sites. A Family Meeting Observation Sheet will capture key components of both types of family meeting to enable comparison of family meeting practices and factors contributing to this practice. At the control site, the same quantitative measures will be undertaken at the same time points. Interviews with patients and families at the control site will only occur if a family meeting was convened as part of the standard care of the patient. A statistical electronic application will analyse the quantitative data and provide results. Patient, family and clinician interview data will be analysed using qualitative data analysis techniques. It is expected that this research will provide evidence about the acceptability, feasibility and value of family meetings in palliative care for patients, families and clinicians.

This randomised control trial will aim to explore the effectiveness of pre-formed, semi-rigid, customised foot orthoses (FOs) in reducing pain; improving quality of life; reducing swelling and tenderness; and improving gait parameters in children suffering from active lower limb involvement in juvenile idiopathic arthritis (JIA). Hypotheses: Primary Outcomes 1. Pre-formed FOs will reduce lower limb pain using visual analogue scale (VAS) in children with JIA Secondary Outcomes 1. Pre-formed FOs will improve quality of life in children with JIA using the Pediatric Quality of Life Questionnaire™ (PedsQL) Rheumatology Module – version 3.0 for children and parents. 2. Pre-formed FOs will improve foot disability in children with JIA using the Juvenile Arthritis Foot Disability Index (JAFI). 3. Pre-formed FOs will reduce localised swelling and tenderness of lower limb joints in children with JIA by visual inspection and palpation. 4. Pre-formed FOs will have an effect on quantitative kinematic and kinetic parameters of gait in children with JIA when barefoot, with shoes alone, and with shoes and FOs. Participant's who are eligible and consent to partake in the research based on the study's inclusion and exclusion criteria will be randomised into two groups. Thirty-three participants will be allocated to the trial intervention group, and the remaining thirty-three will be allocated to the control group. The trial group will receive a pre-formed, semi-rigid, customised foot orthoses, while the control group will receive a placebo device made from basic materials. The control orthoses will be made to resemble standard innersoles in athletic-style footwear. To help prevent participant's on knowing their allocated interventions, the top covers of both the trial and control groups will be made from the same materials. The participant's will be required to wear their allocated interventions for a maximum of 12 months. Primary outcome will be assessed at baseline,4-weeks, 3,6 and 12 months, Quality of life and foot disability will be assessed at baseline, 3,6 and 12 months. Joint swelling and tenderness, and gait parameters will be assessed at baseline, 3 and 6 months. Please note that one previous study was done with a similar methodological approach.(which was given a Clinical Trial ID with Clinicaltrials.gov: NCT02001844) [1]. This particular randomised control trial is unique to this previous study as it will investigate the effectiveness of foot orthoses in the treatment of swollen and tender lower limb joints. It will also be the first study to investigate any type of foot orthoses beyond 6 months in children with JIA. 1. Coda A, Fowlie PW, Davidson JE, Walsh J, Carline T, Santos D. Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial.

The Maxm Skate is a portable lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting. It allows the patient to perform strengthening exercises with minimal joint loading during their rehabilitation period. The primary objective of this randomised controlled study is to assess the range of motion (ROM) achieved by patients whom received the Maxm Skate rehabilitation device compared with standard rehabilitative care, 3 months post total knee replacement. The secondary objectives of the study will be to compare functional, clinical performance and quality of life outcomes following use of the Maxm Skate compared with standard rehabilitative care. An economic evaluation assessing the relative cost-effectiveness of the Maxm Skate rehabilitation device compared to standard care will be also be conducted. Adverse event occurrences and complications will be screened from the time of consent to 1 year postoperatively. We aim to recruit a study sample size of 116 participants, with 58 per group. The primary endpoint is range of movement (ROM) which will be analysed on an intention to treat basis, using linear regression.

The specific aim of this study is to assess if recovery measures and next day performance can be enhanced in well-trained Water Polo athletes through exposure to the phytochemicals found in tart cherry juice. Results will be applicable to elite waterpolo players and team sport athletes. It is hypothesised that cherry jucie would improve recovery and limit any decline in performance at the end of 7 days of hard Water Polo training.

The primary purpose of this trial is to evaluate whether motivational interviewing, when added to a standard cancer rehabilitation program, improves physical activity levels and other health and well-being related outcomes. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over, have been diagnosed with any cancer for which you are currently undergoing treatment or have completed adjuvant therapy in the last 12 months, and have been referred for rehabilitation at Eastern Health. Study details All participants will receive the standard oncology rehabilitation program, which lasts 7 weeks and involves weekly group exercise and education sessions as well as a home exercise program and exercise diary. Participants will be randomly allocated (by chance) to receive this rehabilitation program alone, or to receive motivational interviewing from a physiotherapist via telephone in addition to the rehabilitation program. Participants allocated to this motivational interviewing group will receive 7 weekly telephone calls from a physiotherapist, of approximately 30 minutes in duration, to encourage participants to complete more physical activity. Participants will be asked to wear an activity tracking device and complete a number of questionnaires and physical function tests at the end of the 7 weeks, and some participants will also complete interviews with researchers to provide feedback on the program. It is hoped that this trial will provide evidence about the use of motivational interviewing during an oncology rehabilitation program to inform therapists and managers whether this is an effective intervention to facilitate positive physical activity behaviour.

this trial aims to improve the experiences of children with ASD having an operation in Royal Dental hospital and the Royal Children's Hospital . The participants will be selected from operating list and a preparation package will be sent after verbal consent. on the day of operation if the child requires premedication, they are randomised to clonidine plus midazolam at lower doses vs. placebo plus standard dose of midazolam. the primary end point is the quality of induction as measured by Almanrader scale.

This research project is being conducted to look at how safe, well tolerated and effective a new drug called DUR-928 is when given as an interlesional injection to participants with plaque-type psoriasis. The study will look at comparing the study drug’s safety, tolerability and effectiveness as a treatment for psoriasis using 2 different formulations when compared against placebo vehicle formulations, an active comparator and no treatment at all.