PD COMM Study
- Conditions
- Parkinson's diseaseNervous System Diseases
- Registration Number
- ISRCTN12421382
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 388
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 01/11/2019:<br>The functional, physical and emotional impacts of a voice disorder on a patient's quality of life is measured using the Voice Handicap Index (VHI) at 3 months<br><br>Previous primary outcome measure:<br>The functional, physical and emotional impacts of a voice disorder on a patient's quality of life is measured using the Voice Handicap Index (VHI) at baseline 3, 6 and 12 months
- Secondary Outcome Measures
Name Time Method