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

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  1 , Christina H Smith  2 , Caroline E Rick  3 , Marian C Brady  4 , Natalie Ives  3 , Smitaa Patel  3 , Rebecca Woolley  3 , Francis Dowling  3 , Ramilla Patel  5 , Helen Roberts  6 , Sue Jowett  7 , Keith Wheatley  8 , Debbie Kelly  9 , Gina Sands  10 , Carl E Clarke  7   11 ; PD COMM Pilot Collaborative Group
Affiliations

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 et al. Pilot Feasibility Stud. .

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.

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Conflict of interest statement

West Midlands, Coventry and Warwick NHS Research Ethics Committee (11/WM/0343), and local NHS R&D approval at each site.Patients consented to participate in the trial and the publication of anonymised data.CEC received honoraria for lectures, travel expenses for conferences, and unrestricted educational grants from AbbVie, BIAL, Britannia, Teva/Lundbeck, and UCB.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of patients through the trial
Fig. 2
Fig. 2
VHI total score over time
Fig. 3
Fig. 3
PDQ-39 communication domain over time
See this image and copyright information in PMC

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