A pilot assessor-blinded randomised controlled trial of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy in Parkinson's Disease

ISRCTN	ISRCTN75223808
DOI	https://doi.org/10.1186/ISRCTN75223808
Secondary identifying numbers	11652

Submission date: 22/03/2012
Registration date: 22/03/2012
Last edited: 30/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Caroline Rick
Scientific

University of Birmingham
Birmingham Clinical Trials Unit
Division of Cancer Studies
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	c.e.rick@bham.ac.uk

Study information

Study design	Randomised interventional treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A pilot assessor-blinded randomised controlled trial of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy in Parkinson's Disease
Study acronym	PD COMM Pilot
Study hypothesis	Parkinsons disease (PD) is a common movement disorder, affecting approximately 120,000 people in the UK. Over two thirds of people with PD report having speech-related problems which has a great impact on their lives, leading to increased physical and mental demands during conversation, reduced independence and social withdrawal. Speech and language therapy (SLT) is advocated for people with PD but current provision is low, with a recent Parkinsons UK survey reporting that just 37% of the patients included had received SLT. This may be attributed, in part, to the limited scientific evidence of a benefit of SLT for people with PD. Currently 2 different types of SLT are available in the UK: standard NHS SLT, typically consisting of 1 hour per week for 6 - 8 weeks and Lee Silverman Voice Training (LSVT), a more intensive therapy comprising of 4 sessions per week for 4 weeks. From the literature it is unclear if one or both of these treatments is effective or acceptable to people with PD, and if there is a benefit whether it continues once the treatments have stopped. We propose a pilot study in which LSVT, traditional NHS SLT and a no intervention control will be compared in people with PD. People with PD will be randomly assigned to one of the 3 groups and their communication effectiveness and quality of life will be compared before and after treatment, and 6 and 12 (Participant forms only) months later to see if any benefit remains. This pilot trial will be used to assess the feasibility of running a larger trial with enough participants to determine if either or both treatments are effective. The pilot will test recruitment, compliance, outcome measures and effect size. In light of the findings, the design of the study may be refined for the large scale trial.
Ethics approval(s)	First MREC 22/11/2011, ref: 11/WM/0343
Condition	Parkinson's disease
Intervention	Patient will be randomised between Standard NHS SLT versus Lee Silverman Voice Training versus no treatment. Patients who recieve therapy should do so within one month of randomisation and have their course finished by three months. Followed up at 12 months.
Intervention type	Other
Primary outcome measure	VHI - Voice Handicap Index measured at baseline, 3 months, 6 months & 12 months.
Secondary outcome measures	1. AIDS - Assessment of Intelligibility of Dysarthic Speech measured at baseline, 3 months, 6 months 2. Comprehension Assessment measured at baseline, 3 months, 6 months 3. EQ-5D - Euroqol measured at baseline, 3 months, 6 months & 12 months 4. ICECAP-O measured at baseline, 3 months, 6 months & 12 months 5. LwD - Living with Dysarthia questionnaire measured at baseline, 3 months, 6 months & 12 months 7. Parkinson's Disease Carers' Questionnaire Quality of Life Assessment measured at baseline, 3 months, 6 months & 12 months 8. PDQ-39 - Parkinsons Disease Questionnaire 39 measured at baseline, 3 months, 6 months & 12 months 9. Resource Usage measured at 3 months, 6 months & 12 months 10. Vocal Loudness measured at baseline, 3 months, 6 months 11. V-RQoL - Voice related Quality of Life Scale measured at baseline, 3 months, 6 months & 12 months.
Overall study start date	01/04/2012
Overall study end date	31/10/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 60
Participant inclusion criteria	1. Idiopathic Parkinsons disease defined by the UK PDS Brain Bank Criteria. These criteria are in standard use throughout the NHS in the UK and were supported by the NICE guidelines. 2. PD patients who have self or carer-reported problems when asked: "Do you have any problems with your speech or voice?" by their physician or PD nurse specialist 3. Male and female participants
Participant exclusion criteria	1. Dementia as usually defined clinically by the patients physician. From our experience in PD MED, some patients with moderate to severe dementia have difficulty in completing self-assessment forms 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 in the last 2 year 4. The investigator is certain the person will need SLT within 6 months
Recruitment start date	01/04/2012
Recruitment end date	31/10/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Early Drug Development Centre for Clinical Haematology
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Phone	+44 (0)121 414 3344
Email	abc@email.com
Website	http://www.birmingham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Charity

Dunhill Medical Trust
Private sector organisation / Other non-profit organizations

Alternative name(s): The Dunhill Medical Trust, DMT
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/06/2014		Yes	No
Results article	results	10/01/2018		Yes	No

Editorial Notes

30/01/2018: Publication reference added.