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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
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
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