Falls and mobility in Parkinson's disease: Protocol for a randomised controlled clinical trial

Melbourne School of Health Sciences, The University of Melbourne, 3010, Melbourne, Australia.
BMC Neurology (Impact Factor: 2.04). 07/2011; 11(1):93. DOI: 10.1186/1471-2377-11-93
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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).
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.
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.
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594.

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Available from: Sze-Ee Soh, Oct 07, 2015
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    • "Finally, for the FES- I, a sample size of 32 subjects was required to detect a difference of 2 points (SD 2.8) between groups (effect size = 0.71). The dropout rate was set at 15%, corresponding to intervention studies with PD subjects [75,76]. Taken together, to ensure adequate statistical power the sample size for this study would optimally be 40 per group (total n = 80). "
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    ABSTRACT: Background There is increasing scientific knowledge about the interaction between physiological (musculoskeletal, neuromuscular, cognitive and sensory) systems and their influence on balance and walking impairments in Parkinson’s disease. We have developed a new conceptual framework for balance training, emphasising specific components of balance control related to Parkinson’s disease symptoms by using highly challenging, progressive and varying training conditions. The primary aim of this proposed randomised controlled trial will be to investigate the short-term and long-term effects of a 10-week balance training regime in elderly with Parkinson’s disease. Methods/Design Eighty participants with mild to moderate idiopathic Parkinson’s disease will be recruited and randomly allocated to an intervention group receiving balance training or a control group whose participants will continue to receive their usual care. The intervention will consist of a 10-week group training regime (1-hour training, three times per week), which will be led by two physiotherapists to ensure training progression and safety. The conceptual framework will be applied by addressing specific balance components (sensory integration, anticipatory postural adjustments, motor agility, stability limits) through varying training conditions and structured progression. Assessment will be conducted through a multi-dimensional battery of outcomes, prior to and immediately after the 10-week intervention, and at 9 and 15 months’ follow-up after entering the study. Primary outcome measures will be balance performance (assessed using the Mini Balance Evaluation Systems Test), change in gait velocity (m/s) between single and dual task walking, and fear of falling (evaluated using the Fall Efficacy Scale International). Discussion This study has the potential to provide new insight and knowledge of the effects of specific, varied and challenging balance training on a wide health spectrum in elderly with PD. If found to be effective, this pragmatic approach with translation of theory into practice, can be implemented in existing outpatient care. Trial registration NCT01417598
    BMC Neurology 09/2012; 12(1):111. DOI:10.1186/1471-2377-12-111 · 2.04 Impact Factor
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    • "The study formed part of a larger clinical randomized controlled trial that investigated the efficacy of two physiotherapy programs relative to a control intervention to reduce falls and improve mobility in people with PD (see [16] for full details). Participants were drawn from general medical practitioners, neurologists, Parkinson’s Victoria network and advertisements in local papers. "
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    ABSTRACT: 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. 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. 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). 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.
    BMC Neurology 07/2012; 12(1):57. DOI:10.1186/1471-2377-12-57 · 2.04 Impact Factor
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    • "MST will be based upon the principles previously described in detail by Morris [2,26,27] emphasizing evidence-based training techniques for people with Parkinson’s. These include the ability of participants to initiate and execute everyday functional activities, facilitated as appropriate by the use of cues (visual, auditory, cognitive or proprioceptive) and attentional strategies, such as conscious attention strategies, such as conscious attention. "
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    ABSTRACT: The high incidence of falls associated with Parkinson's disease (PD) increases the risk of injuries and immobility and compromises quality of life. Although falls education and strengthening programs have shown some benefit in healthy older people, the ability of physical therapy interventions in home settings to reduce falls and improve mobility in people with Parkinson's has not been convincingly demonstrated. 180 community living people with PD will be randomly allocated to receive either a home-based integrated rehabilitation program (progressive resistance strength training, movement strategy training and falls education) or a home-based life skills program (control intervention). Both programs comprise one hour of treatment and one hour of structured homework per week over six weeks of home therapy. Blinded assessments occurring before therapy commences, the week after completion of therapy and 12 months following intervention will establish both the immediate and long-term benefits of home-based rehabilitation. The number of falls, number of repeat falls, falls rate and time to first fall will be the primary measures used to quantify outcome. The economic costs associated with injurious falls, and the costs of running the integrated rehabilitation program from a health system perspective will be established. The effects of intervention on motor and global disability and on quality of life will also be examined. This study will provide new evidence on the outcomes and cost effectiveness of home-based movement rehabilitation programs for people living with PD. The trial is registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12608000390381).
    BMC Neurology 07/2012; 12:54. DOI:10.1186/1471-2377-12-54 · 2.04 Impact Factor
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