| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN40910122 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0016131978 |
| 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 |
| Disease/condition/study domain | Nervous System Diseases: Parkinson's disease |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
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| Anticipated start date | 08/08/2003 |
| Anticipated end date | 10/01/2005 |
| Status of trial | Completed |
| 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) |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Ms Deirdre Cotter |
| Contact details | Department of Speech and Language Therapy
Hammersmith Hospital
Du Cane Road
London
United Kingdom
W12 0HS |
| Contact telephone | +44 (0)208 383 3076 |
| Contact email | DCotter@hhnt.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN40910122 |
| Date last extracted from ISRCTN register | 17/04/2008 |
