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Open Access Highly Accessed Study protocol

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

Meg E Morris1*, Hylton B Menz2, Jennifer L McGinley13, Frances E Huxham1, Anna T Murphy13, Robert Iansek3, Mary Danoudis13, Sze-Ee Soh1, David Kelly1 and Jennifer J Watts14

Author Affiliations

1 Melbourne School of Health Sciences, The University of Melbourne, 3010, Melbourne, Australia

2 Musculoskeletal Research Centre, Faculty of Health Sciences, La Trobe University, 3086, Australia

3 National Parkinson Foundation Center for Excellence, Clinical Research Centre for Movement Disorders and Gait and Victorian Comprehensive Parkinson's Program, Kingston Centre, Warrigal Rd, Cheltenham, 3092, Australia

4 Centre for Health Economics, Monash University, Building 75, Clayton, 3168, Melbourne, Australia

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BMC Neurology 2011, 11:93  doi:10.1186/1471-2377-11-93

Published: 31 July 2011

Abstract

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