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 therapy arms and 100% in the control arm 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
- Parkinson's disease; pilot randomised controlled trial; speech and language therapy