Condition category
Mental and Behavioural Disorders
Date applied
22/03/2012
Date assigned
22/03/2012
Last edited
09/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Caroline Rick

ORCID ID

Contact details

University of Birmingham
Birmingham Clinical Trials Unit
Division of Cancer Studies
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom
c.e.rick@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11652

Study information

Scientific title

Acronym

PD COMM Pilot

Study hypothesis

Parkinson’s 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 Parkinson’s 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

First MREC 22 November 2011 ref: 11/WM/0343

Study design

Randomised interventional treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2012

Overall trial end date

31/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Idiopathic Parkinson’s 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Dementia as usually defined clinically by the patient’s 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

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Early Drug Development Centre for Clinical Haematology
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3344

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/

Funders

Funder type

Charity

Funder name

The Dunhill Medical Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24908096

Publication citations

  1. Protocol

    Sackley CM, Smith CH, Rick C, Brady MC, Ives N, Patel R, Roberts H, Dowling F, Jowett S, Wheatley K, Patel S, Kelly D, Sands G, Clarke C, Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial., Trials, 2014, 15, 213, doi: 10.1186/1745-6215-15-213.

Additional files

Editorial Notes