title: Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Parkinson's disease is a common movement disorder affecting approximately 127,000 people in the UK, with an estimated two thirds having speech-related problems. Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment. This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson's disease-related speech or voice problems to Lee Silverman voice treatment or standard speech and language therapy compared to a no-intervention control.
  
  
  METHODS
  The PD COMM pilot is a three arm, assessor-blinded, randomized controlled trial. Randomization will be computer-generated with participants randomized at a ratio of 1:1:1. Participants randomized to intervention arms will be immediately referred to the appropriate speech and language therapist. The target population are patients with a confirmed diagnosis of idiopathic Parkinson's disease who have problems with their speech or voice. The Lee Silverman voice treatment intervention group will receive the standard regime of 16 sessions between 50 and 60 minutes in length over four weeks, with extra home practice. The standard speech and language therapy intervention group will receive a dose determined by patients' individual needs, but not exceeding eight weeks of treatment. The control group will receive standard care with no speech and language therapy input for at least six months post-randomization. Outcomes will be assessed at baseline (pre-randomization) and post- randomization at three, six, and 12 months. The outcome measures include patient-reported voice measures, quality of life, resource use, and assessor-rated speech recordings. The recruitment aim is at least 60 participants over 21 months from 11 sites, equating to at least 20 participants in each arm of the trial. This trial is ongoing and recruitment commenced in May 2012.
  
  
  CONCLUSIONS
  This study will provide information on the feasibility and acceptability of randomizing participants to different speech and language therapies or control/deferred treatment. The findings relating to recruitment, treatment compliance, outcome measures, and effect size will inform a future phase III randomized controlled trial.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number Register: ISRCTN75223808 registered 22 March 2012.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Sackley
authors.forename: Christina H
authors.initials: CH
authors.lastname: Smith
authors.forename: Caroline
authors.initials: C
authors.lastname: Rick
authors.forename: Marian C
authors.initials: MC
authors.lastname: Brady
authors.forename: Natalie
authors.initials: N
authors.lastname: Ives
authors.forename: Ramilla
authors.initials: R
authors.lastname: Patel
authors.forename: Helen
authors.initials: H
authors.lastname: Roberts
authors.forename: Francis
authors.initials: F
authors.lastname: Dowling
authors.forename: Sue
authors.initials: S
authors.lastname: Jowett
authors.forename: Keith
authors.initials: K
authors.lastname: Wheatley
authors.forename: Smitaa
authors.initials: S
authors.lastname: Patel
authors.forename: Debbie
authors.initials: D
authors.lastname: Kelly
authors.affiliation: School of Rehabilitation Sciences, University of East Anglia, Earlham Road, Norwich NR4 7TJ, UK. g.sands@uea.ac.uk.
authors.forename: Gina
authors.initials: G
authors.lastname: Sands
authors.forename: Carl
authors.initials: C
authors.lastname: Clarke
mesh_terms: D006801:Humans; D010300:Parkinson Disease / Q000150:complications*; D010349:Patient Compliance; D010865:Pilot Projects; D012107:Research Design; D013070:Speech Therapy / Q000379:methods*; D014831:Voice; D014832:Voice Disorders / Q000209:etiology* / Q000628:therapy*; D014834:Voice Training