title: A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's: study protocol.
abstract: BACKGROUND
  Falls amongst people with Parkinson's (PwP) result in significant disability and reduced quality of life. There is emerging evidence that exercise-based and physiotherapeutic interventions are of benefit for improving fall risk factors, such as balance. However, the benefit, in terms of preventing falls, is mixed. The development of effective interventions has been identified as the highest research priority for this population. The aim of this trial is to establish the effectiveness and cost-effectiveness of a novel, home-based physiotherapy programme, compared with usual care, on falls amongst PwP.
  
  
  METHODS
  A UK multi-centre, community-based, single blind, randomised controlled trial with twelve month follow-up, and nested economic evaluation and qualitative studies will be undertaken. Six hundred PwP who live in their own home, have had one or more falls in the previous year and an MMSE score of ≥24 will be recruited. Those living in care homes and those needing assistance from another person to walk indoors will not be eligible. The intervention is a physiotherapist delivered, individually tailored and progressive, home-based programme (PDSAFE) comprising task orientated movement strategy training, functional lower limb strengthening and balance training, of six months duration. Unsupervised daily home exercises and strategies will be practised and supported using technology. Control participants will receive usual care. Data collection will include falls, cognitive state, balance and mobility, fear of falling, freezing of gait, mood, quality of life, carer quality of life and resource use. Data will be collected at baseline, three, six and twelve months. Longitudinal semi-structured interviews will be undertaken with forty participants to explore the expectations and experiences of participants. The primary outcome is risk of repeat falling at six months post-randomisation.
  
  
  CONCLUSIONS
  The aims of this trial are to establish the effectiveness and cost-effectiveness of a novel, home-delivered physiotherapy intervention (PDSAFE) compared with usual care on risk of falling for PwP who have a history of falling. PDSAFE is a novel intervention that builds upon the existing literature and targeting known risk factors, being the first study that uses a novel delivery modus (technology) in conjunction with traditional physiotherapeutic approaches.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN48152791.
authors.affiliation: University of Exeter, Exeter, UK. v.goodwin@exeter.ac.uk.
authors.forename: Victoria A
authors.initials: VA
authors.lastname: Goodwin
authors.affiliation: University of Southampton, Southampton, UK. r.m.pickering@soton.ac.uk.
authors.forename: Ruth
authors.initials: R
authors.lastname: Pickering
authors.affiliation: University of Southampton, Southampton, UK. c.ballinger@soton.ac.uk.
authors.forename: Claire
authors.initials: C
authors.lastname: Ballinger
authors.affiliation: University of Southampton, Southampton, UK. hcr@soton.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Roberts
authors.affiliation: University of Glasgow, Glasgow, UK. emma.mcintosh@glasgow.ac.uk.
authors.forename: Emma
authors.initials: E
authors.lastname: McIntosh
authors.affiliation: University of Oxford, Oxford, UK. Sarah.lamb@ndorms.ox.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Lamb
authors.affiliation: University of Leuven, Leuven, Belgium. Alice.Nieuwboer@faber.kuleuven.be.
authors.forename: Alice
authors.initials: A
authors.lastname: Nieuwboer
authors.affiliation: Newcastle University, Newcastle, UK. Lynn.rochester@ncl.ac.uk.
authors.forename: Lynn
authors.initials: L
authors.lastname: Rochester
authors.affiliation: University of Southampton, Southampton, UK. ann@soton.ac.uk.
authors.forename: Ann
authors.initials: A
authors.lastname: Ashburn
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D002985:Clinical Protocols; D005081:Exercise Therapy / Q000379:methods*; D006801:Humans; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care; D020734:Parkinsonian Disorders / Q000534:rehabilitation*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D016037:Single-Blind Method