Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson's disease: a pilot randomised controlled trial (PD COMM pilot)

Catherine M Sackley; Christina H Smith; Caroline E Rick; Marian C Brady; Natalie Ives; Smitaa Patel; Rebecca Woolley; Francis Dowling; Ramilla Patel; Helen Roberts; Sue Jowett; Keith Wheatley; Debbie Kelly; Gina Sands; Carl E Clarke; PD COMM Pilot Collaborative Group

doi:10.1186/s40814-017-0222-z

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson's disease: a pilot randomised controlled trial (PD COMM pilot)

Pilot Feasibility Stud. 2018 Jan 10:4:30. doi: 10.1186/s40814-017-0222-z. eCollection 2018.

Authors

Catherine M Sackley¹, Christina H Smith², Caroline E Rick³, Marian C Brady⁴, Natalie Ives³, Smitaa Patel³, Rebecca Woolley³, Francis Dowling³, Ramilla Patel⁵, Helen Roberts⁶, Sue Jowett⁷, Keith Wheatley⁸, Debbie Kelly⁹, Gina Sands¹⁰, Carl E Clarke^{7

11}; PD COMM Pilot Collaborative Group

Affiliations

¹ 1Faculty of Life Sciences and Medicine, King's College London, London, UK.
² 2Division of Psychology and Language Science, Faculty of Brain Sciences, University College London, London, UK.
³ 3Birmingham Clinical Trials Unit (BCTU), University of Birmingham, Birmingham, UK.
⁴ 4Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
⁵ 5Parkinson's UK West Midlands Regional Branch, London, UK.
⁶ 6Faculty of Medicine, University of Southampton, London, UK.
⁷ 7Institute for Applied Health Research, University of Birmingham, Birmingham, UK.
⁸ 8Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.
⁹ 9School of Rehabilitation Sciences, University of East Anglia, Norwich, UK.
¹⁰ 11School of Health Sciences, University of Nottingham, Nottingham, UK.
¹¹ 10Department of Neurology, Clinical Neurology City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Dudley Road, Birmingham, B18 7QH UK.

Abstract

Background: Speech-related problems are common in Parkinson's disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®).

Methods: The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6-8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings.

Results: Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: - 12.5 points; 95% CI - 26.2, 1.2) and SLT (difference at 3 months compared with control: - 9.8 points; 95% CI - 23.2, 3.7) which needs to be confirmed in an adequately powered trial.

Conclusion: Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient-reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial.

Trial registration: International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. registered 22 March 2012.

Keywords: Parkinson’s disease; Pilot randomised controlled trial; Speech and language therapy.