|
ISRCTN
|
ISRCTN40910122
|
|
ClinicalTrials.gov identifier
|
|
|
Public 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
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0016131978
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Nervous System Diseases: Parkinson's disease
|
|
Participants - inclusion criteria
|
Twenty-seven patients with Parkinson's Disease (PD) will be recruited to the pilot study. Entry criteria will be as follows:
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)
|
|
Participants - 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
|
|
Anticipated start date
|
08/08/2003
|
|
Anticipated end date
|
10/01/2005
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
27
|
|
Interventions
|
Not provided at time of registration
|
|
Primary outcome measure(s)
|
Publication
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Hammersmith Hospital NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Ms
Deirdre
Cotter
|
|
Address
|
Department of Speech and Language Therapy
Hammersmith Hospital
Du Cane Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
W12 0HS
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)208 383 3076
|
|
Email
|
DCotter@hhnt.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
09/10/2006
|
|
Date ISRCTN assigned
|
30/09/2004
|