Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively 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

Ms Deirdre Cotter

ORCID ID

Contact details

Department of Speech and Language Therapy
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)208 383 3076
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016131978

Study information

Scientific title

A Pilot Study to Investigate if Frequency of Therapy Alters Outcomes of the Lee Silverman Voice Treatment (LSVT) Programme for Patients with Parkinson's Disease

Acronym

Study hypothesis

A Pilot Study to Investigate if Frequency of Therapy Alters Outcomes of the Lee Silverman Voice Treatment (LSVT) Programme for Patients with Parkinson's Disease

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Nervous System Diseases: Parkinson's disease

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Publication

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/08/2003

Overall trial end date

10/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients entering the study will have volunteered for the study and will have agreed to be randomly allocated to either a control group or one of two treatment groups.
2. A diagnosis of idiopathic PD
3. Categorised between stages 1 to 4 on the `Functional Rating Scale for Parkinson's Disease¿, Hoehn & Yahr (1967)
4. Neuropharmacologically stable before and during treatment
5. Fluent English speakers
6. Intelligibility of speech will have received a rating of between 5 and 9 on the Parkinson¿s disease disability rating scale. (Yorkston 1995)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

27

Participant exclusion criteria

1. Any history of a language deficit caused by a past event such as a cardiovascular event
2. Evidence of a cognitive deficit on the `Mini-Mental State Examination (score >24), Folstein et al 1975
3. Evidence of depression on the Beck Depression inventory (score <14), Beck & Beck 1972.
4. History of a chronic hearing loss or report/suspected hearing loss
5. History of laryngeal disease and will be free of acute cardiac and respiratory conditions during the study

Recruitment start date

08/08/2003

Recruitment end date

10/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Hammersmith Hospital NHS 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

Publication citations

Additional files

Editorial Notes