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Open Access Study protocol

The ReSPonD trial - rivastigmine to stabilise gait in Parkinson’s disease a phase II, randomised, double blind, placebo controlled trial to evaluate the effect of rivastigmine on gait in patients with Parkinson’s disease who have fallen

Emily J Henderson1*, Stephen R Lord2, Jacqueline CT Close23, Andrew D Lawrence4, Alan Whone56 and Yoav Ben-Shlomo1

Author Affiliations

1 Department of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, BS8 2PS Bristol, UK

2 Neuroscience Research Australia, University of New South Wales, Sydney, Australia

3 Prince of Wales Clinical School, Department of Geriatric Medicine, Sydney, NSW, Australia

4 School of Psychology, Cardiff University, Cardiff, UK

5 Department of Neurology, Institute of Clinical Neurosciences, University of Bristol, Bristol, UK

6 North Bristol NHS Trust, Bristol, UK

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BMC Neurology 2013, 13:188  doi:10.1186/1471-2377-13-188

Published: 3 December 2013

Abstract

Background

Gait impairment is common in people with Parkinson’s disease. There is a lack of effective interventions to target this debilitating complication and therefore a need to identify new therapeutic options. An underlying cholinergic deficit contributes to both the gait and cognitive dysfunction seen in Parkinson’s disease. The combined impact of both impairments can be assessed in gait tasks performed with concomitant cognitive tasks. The aim of this trial is to evaluate the impact of a cholinesterase inhibitor on cognitive function and gait performance in people with established Parkinson’s disease.

Methods/design

This is a single centre, double-blind, randomised placebo-controlled trial in 130 people with Hoehn and Yahr stage 2–3 idiopathic Parkinson’s disease who have fallen in the past year. Participants will be randomised to two groups, receiving either rivastigmine capsules or identical placebo capsules for 8 months. Assessment will be undertaken at baseline and at the end of medication prescription (i.e. 8 months) with participants remaining enrolled in the trial for a further 4 months to monitor for falls and adverse events. The primary outcome is step time variability, assessed with and without the addition of concurrent cognitive tasks. Secondary outcomes will include other gait parameters, sensorimotor and balance performances, cognitive indices, falls and fall related injury, fear of falling, Parkinson’s symptoms and data pertaining to possible harms.

Discussion

This randomised controlled trial will examine the effect of cholinesterase inhibitor therapy on gait, balance and falls in Parkinson’s disease. If effective, it would offer a new therapeutic option to ameliorating gait and cognitive deficits in a population at high risk of falls.

Trial registration

ISRCTN19880883, UTN U1111-1124-0244.

Keywords:
Randomised control trial; Parkinson’s disease; Accidental Falls; Freezing of gait; Intervention; Gait analysis; Acetylcholinesterase; Cognitive; Attention; Dual-tasking