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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list