Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Patient will be randomised to one of three study arms.
Group 1: Participants take part in four one-hour sessions of LSVT with a therapist per week and daily home based practice of varying length for
improving phonation and vocal loudness through better vocal fold adduction. The intervention will replicate the dose and content recommended by the originators and delivered in clinical practice and p
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 01/11/2019: 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 Previous primary outcome measure: 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/04/2019: 1. Subscales of the VHI: emotional, functional, and physical at baseline and 3, 6 & 12 months; 2. Parkinson’s Disease Questionnaire 39 (PDQ-39) summary index and the eight individual dimensions of the PDQ-39: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort at baseline and 3, 6 & 12 months; 3. Questionnaire on Acquired Speech Disorders (QASD) at baseline and 3, 6 & 12 months; 4. EuroQol-5D-5L and visual analogue scale at baseline and 3, 6 & 12 month; 5. ICEpop CAPability measure for Older people (ICECAP-O) at baseline and 3, 6 & 12 months; 6. Hoehn and Yahr stage at baseline and 12 months; 7. Adverse and Serious Adverse Events; 8. Parkinson’s Disease Questionnaire - Carers (PDQ-Carer) at baseline and 3, 6 & 12 months; Previous secondary outcome measures: 1. Self-completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson's disease is measured using the Parkinsons Disease Questionnaire 39 (PDQ-39) at baseline 3, 6 and 12 months 2. The impact that the voice disorder is having on the patient's voice-related quality of life is measured using the Voice related Quality of Life Scale (V-RQoL) is measured at baseline 3, 6 and 12 months 3. Evaluate the speech difficulties as perceived by individuals with dysarthria is measured using the Living with Dysarthria questionnaire (LwD) is measured at baseline 3, 6 and 12 months 4. Quality of Life measure is measured using the EQ-5D - Euroqol is measured at baseline 3, 6 and 12 months 5. Measure of capability in older people for use in economic evaluation is measured using the ICECAP-O (ICEpop CAPability measure for Older people) at baseline 3, 6 and 12 months 6. Resource Usage is measured using the resource usage questionnaire at baseline 3, 6 and 12 months 7. Carers Quality of Life is measured using the Parkinson's Disease Carers' Questionnaire at bas | — |
Countries
England, United Kingdom
Contacts
Public ContactPui Au
Outcome results
None listed