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 (LSVTLSVT LOUD®).
Methods: The PD COMM pilot was a three-arm, assessor-blinded, randomised, controlled trial (RCT) ofcomparing LSVTLSVT LOUD®, SLT andversus 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. LSVTLSVT 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 assessedcollected 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 armgroups and 100% in the control grouparm 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 LSVTLSVT 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
Key Words: Parkinson's disease; pilot randomised controlled trial; speech and language therapy
Methods: The PD COMM pilot was a three-arm, assessor-blinded, randomised, controlled trial (RCT) ofcomparing LSVTLSVT LOUD®, SLT andversus 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. LSVTLSVT 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 assessedcollected 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 armgroups and 100% in the control grouparm 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 LSVTLSVT 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
Key Words: Parkinson's disease; pilot randomised controlled trial; speech and language therapy
Original language | English |
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Journal | Pilot and Feasibility Studies |
Volume | 4 |
Issue number | 30 |
DOIs | |
Publication status | Published - 10 Jan 2018 |
Keywords
- Parkinson's disease
- pilot randomised controlled trial
- Speech and language therapy