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1.  Do external stimuli impact the gait of children with idiopathic toe walking? A study protocol for a within-subject randomised control trial 
BMJ Open  2013;3(3):e002389.
Introduction
Frequently, toe walking gait is the result of disease processes, trauma or neurogenic influences. Idiopathic toe walking (ITW) is, by definition, the diagnosis of a toe walking gait adopted in the absence of one of these medical conditions. Long-term ITW has been associated with reduced ankle range of motion. Reported treatments have included serial casting, Botulinum toxin type A or surgery to improve the ankle range of motion. Investigating the impact of simple and non-invasive treatment options for ITW is important for future research and clinical outcomes. This study investigates the immediate impact of footwear, footwear with orthotics and whole body vibration on ITW to determine if any one intervention improves heel contact and spatial-temporal gait measures. This determination is important for future clinical trials into treatment effectiveness.
Methods and analysis
Design: this protocol describes a within-subject randomised controlled trial that measures changes in gait following changes in external stimuli. Participants: 15 children diagnosed with an ITW gait will be recruited from the Victorian Paediatric Rehabilitation Service at Monash Children's Hospital Toe Walking Clinic provided they have ITW and meet the inclusion criteria. Procedure: participants will have their gait recorded walking barefoot, in usual footwear, a custom-made, full-length carbon fibre orthotic in usual footwear and following whole body vibration. Outcome measures will include the presence of bilateral heel contact preintervention and postintervention, stride length (cm), stride width (cm), left and right stride time (s), left and right stance and swing percentage of the gait cycle, gait velocity (m/s), left and right foot toe in/toe out angle (°) and weight-bearing lunge pre and post each condition.
Ethics and dissemination
The results of this study will be published at the conclusion and have been approved by Southern Health HREC:12102B.
Clinical trial registry number
ACTRN12612000975897.
doi:10.1136/bmjopen-2012-002389
PMCID: PMC3612749  PMID: 23454667
2.  Health-related quality of life and strain in caregivers of Australians with Parkinson’s disease: An observational study 
BMC Neurology  2012;12:57.
Background
The relationship between health-related quality of life (HRQoL) in people with Parkinson’s disease and their caregivers is little understood and any effects on caregiver strain remain unclear. This paper examines these relationships in an Australian sample.
Methods
Using the generic EuroQol (EQ-5D) and disease-specific Parkinson’s Disease Questionnaire-39 Item (PDQ-39), HRQoL was evaluated in a sample of 97 people with PD and their caregivers. Caregiver strain was assessed using the Modified Caregiver Strain Index. Associations were evaluated between: (i) caregiver and care-recipient HRQoL; (ii) caregiver HRQoL and caregiver strain, and; (iii) between caregiver strain and care-recipient HRQoL.
Results
No statistically significant relationships were found between caregiver and care-recipient HRQoL, or between caregiver HRQoL and caregiver strain. Although this Australian sample of caregivers experienced relatively good HRQoL and moderately low strain, a significant correlation was found between HRQoL of people with PD and caregiver strain (rho 0.43, p < .001).
Conclusion
Poor HRQoL in people with PD is associated with higher strain in caregivers. Therapy interventions may target problems reported as most troublesome by people with PD, with potential to reduce strain on the caregiver.
doi:10.1186/1471-2377-12-57
PMCID: PMC3434109  PMID: 22804846
3.  The detrimental effects of emotional process dysregulation on decision-making in substance dependence 
Substance dependence is complex and multifactorial, with many distinct pathways involved in both the development and subsequent maintenance of addictive behaviors. Various cognitive mechanisms have been implicated, including impulsivity, compulsivity, and impaired decision-making. These mechanisms are modulated by emotional processes, resulting in increased likelihood of initial drug use, sustained substance dependence, and increased relapse during periods of abstinence. Emotional traits, such as sensation-seeking, are risk factors for substance use, and chronic drug use can result in further emotional dysregulation via effects on reward, motivation, and stress systems. We will explore theories of hyper and hypo sensitivity of the brain reward systems that may underpin motivational abnormalities and anhedonia. Disturbances in these systems contribute to the biasing of emotional processing toward cues related to drug use at the expense of natural rewards, which serves to maintain addictive behavior, via enhanced drug craving. We will additionally focus on the sensitization of the brain stress systems that result in negative affect states that continue into protracted abstinence that is may lead to compulsive drug-taking. We will explore how these emotional dysregulations impact upon decision-making controlled by goal-directed and habitual action selections systems, and, in combination with a failure of prefrontal inhibitory control, mediate maladaptive decision-making observed in substance dependent individuals such that they continue drug use in spite of negative consequences. An understanding of the emotional impacts on cognition in substance dependent individuals may guide the development of more effective therapeutic interventions.
doi:10.3389/fnint.2012.00101
PMCID: PMC3491319  PMID: 23162443
addiction; emotion; cognition; reward; stress; decision-making
4.  Feasibility, Safety, and Compliance in a Randomized Controlled Trial of Physical Therapy for Parkinson's Disease 
Parkinson's Disease  2011;2012:795294.
Both efficacy and clinical feasibility deserve consideration in translation of research outcomes. This study evaluated the feasibility of rehabilitation programs within the context of a large randomized controlled trial of physical therapy. Ambulant participants with Parkinson's disease (PD) (n = 210) were randomized into three groups: (1) progressive strength training (PST); (2) movement strategy training (MST); or (3) control (“life skills”). PST and MST included fall prevention education. Feasibility was evaluated in terms of safety, retention, adherence, and compliance measures. Time to first fall during the intervention phase did not differ across groups, and adverse effects were minimal. Retention was high; only eight participants withdrew during or after the intervention phase. Strong adherence (attendance >80%) did not differ between groups (P = .435). Compliance in the therapy groups was high. All three programs proved feasible, suggesting they may be safely implemented for people with PD in community-based clinical practice.
doi:10.1155/2012/795294
PMCID: PMC3236432  PMID: 22191076
5.  Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial 
BMC Neurology  2011;11:93.
Background
Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group).
Methods/Design
People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy.
Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes.
Discussion
This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594
doi:10.1186/1471-2377-11-93
PMCID: PMC3160881  PMID: 21801451
6.  A diagnostic PCR assay for the detection of an Australian epidemic strain of Pseudomonas aeruginosa 
Background
Chronic lung infection with the bacterium Pseudomonas aeruginosa is one of the hallmarks of cystic fibrosis (CF) and is associated with worsening lung function, increased hospitalisation and reduced life expectancy. A virulent clonal strain of P. aeruginosa (Australian epidemic strain I; AES-I) has been found to be widespread in CF patients in eastern Australia.
Methods
Suppression subtractive hybridization (SSH) was employed to identify genetic sequences that are present in the AES-I strain but absent from the sequenced reference strain PAO1. We used PCR to evaluate the distribution of several of the AES-I loci amongst a collection of 188 P. aeruginosa isolates which was comprised of 35 AES-I isolates (as determined by PFGE), 78 non-AES-I CF isolates including other epidemic CF strains as well as 69 P. aeruginosa isolates from other clinical and environmental sources.
Results
We have identified a unique AES-I genetic locus that is present in all 35 AES-I isolates tested and not present in any of the other 153 P. aeruginosa strains examined. We have used this unique AES-I locus to develop a diagnostic PCR and a real-time PCR assay to detect the presence of P. aeruginosa and AES-I in patient sputum samples.
Conclusions
We have developed diagnostic PCR assays that are 100% sensitive and 100% specific for the P. aeruginosa strain AES-I. We have also shown that Whatman FTA® Elute cards may be used with PCR-based assays to rapidly detect the presence of P. aeruginosa strains in CF sputum.
doi:10.1186/1476-0711-9-18
PMCID: PMC2912777  PMID: 20637114
7.  Quantifying the profile and progression of impairments, activity, participation, and quality of life in people with Parkinson disease: protocol for a prospective cohort study 
BMC Geriatrics  2009;9:2.
Background
Despite the finding that Parkinson disease (PD) occurs in more than one in every 1000 people older than 60 years, there have been few attempts to quantify how deficits in impairments, activity, participation, and quality of life progress in this debilitating condition. It is unclear which tools are most appropriate for measuring change over time in PD.
Methods and design
This protocol describes a prospective analysis of changes in impairments, activity, participation, and quality of life over a 12 month period together with an economic analysis of costs associated with PD. One-hundred participants will be included, provided they have idiopathic PD rated I-IV on the modified Hoehn & Yahr (1967) scale and fulfil the inclusion criteria. The study aims to determine which clinical and economic measures best quantify the natural history and progression of PD in a sample of people receiving services from the Victorian Comprehensive Parkinson's Program, Australia. When the data become available, the results will be expressed as baseline scores and changes over 3 months and 12 months for impairment, activity, participation, and quality of life together with a cost analysis.
Discussion
This study has the potential to identify baseline characteristics of PD for different Hoehn & Yahr stages, to determine the influence of disease duration on performance, and to calculate the costs associated with idiopathic PD. Valid clinical and economic measures for quantifying the natural history and progression of PD will also be identified.
Trial Registration
ACTRN12609000008224
doi:10.1186/1471-2318-9-2
PMCID: PMC2649133  PMID: 19152709
8.  Cost effectiveness of preventing falls and improving mobility in people with Parkinson disease: protocol for an economic evaluation alongside a clinical trial 
BMC Geriatrics  2008;8:23.
Background
Cost of illness studies show that Parkinson disease (PD) is costly for individuals, the healthcare system and society. The costs of PD include both direct and indirect costs associated with falls and related injuries.
Methods
This protocol describes a prospective economic analysis conducted alongside a randomised controlled trial (RCT). It evaluates whether physical therapy is more cost effective than usual care from the perspective of the health care system. Cost effectiveness will be evaluated using a three-way comparison of the cost per fall averted and the cost per quality adjusted life year saved across two physical therapy interventions and a control group.
Conclusion
This study has the potential to determine whether targetted physical therapy as an adjunct to standard care can be cost effective in reducing falls in people with PD.
Trial Registration
No: ACTRN12606000344594
doi:10.1186/1471-2318-8-23
PMCID: PMC2573876  PMID: 18823565
10.  Coagulation Studies in Haemolytic Uraemic Syndrome 
Archives of Disease in Childhood  1972;47(255):766-771.
Serial coagulation investigations were performed in 4 children with the haemolytic uraemic syndrome treated with heparin by continuous infusion. 2 anuric patients showed consumption of factor V and fibrinogen early in the disease, with thrombocytopenia and raised fibrin degradation products. These changes regressed during heparin therapy and renal function fully recovered in both patients. A third patient with a mild form of the disease, normal urinary output, and only borderline thrombocytopenia did not develop demonstrable depletion of factor V or fibrinogen. In a further patient a secondary `wave' of consumption of platelets and perhaps fibrinogen was seen late in the course of the disease. These findings confirmed the occurrence of a consumptive coagulopathy in severe cases of haemolytic uraemic syndrome.
PMCID: PMC1648214  PMID: 5086510

Results 1-10 (10)