A multi-centre randomised controlled trial to compare the clinical and cost effectiveness of Lee Silverman Voice Treatment versus standard NHS speech and language therapy versus control in Parkinson’s disease (PD COMM)

niversity of Birmingham0 个研究点目标入组 388 人开始时间: 2016年4月18日最近更新: 2024年7月22日

适应症

试验速览

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28851443 protocol 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32460885/ protocol (added 29/05/2020) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38986549/ (added 11/07/2024)

•Current inclusion criteria as of 08/04/2019:
•1. People who have idiopathic PD defined by the UK PDS Brain Bank Criteria. These criteria are in standard use throughout the NHS in the UK and supported by the NICE guidelines
•2. Person with PD or carer report problems with their speech or voice when asked
•Previous inclusion criteria:
•1. People who have idiopathic PD defined by the UK PDS Brain Bank Criteria. These criteria are in standard use throughout the NHS in the UK and supported by the NICE guidelines
•2. Person with PD or carer report problems with their speech or voice when asked
•3. Aged 18 years and over

•Current participant exclusion criteria as of 08/04/2019:
•1. Dementia as usually defined clinically by the person with PD’s physician
•2. Evidence of laryngeal pathology including vocal nodules or a history of vocal strain or previous laryngeal surgery within their medical records or from discussions with client, as LSVT is not appropriate for this group
•3. Received SLT for PD speech or voice related problems in the past 2 years
•NB: Individual involvement in the trial is 12 months, but participants randomised to the control group can be referred for SLT at the end of trial (e.g. after 12 months) or, if it becomes medically necessary during the trial (e.g. within 12 months of randomisation).
•Previous participant exclusion criteria:
•1. Dementia as usually defined clinically by the person with PD’s physician
•2. Evidence of laryngeal pathology including vocal nodules or a history of vocal strain or previous laryngeal surgery within their medical records or from discussions with client, as LSVT is not appropriate for this group
•3. Received SLT for PD speech or voice related problems in the past 2 years
•4. The investigator is certain that the person with PD will not require SLT during the 12 months of the trial. Individual involvement in the trial is 12 months, but participants randomised to the deferred treatment group can be referred for therapy after 12 months

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