Trial document
This trial has been registered retrospectively.
DRKS00006333
Trial Description
Title
Speech Therapy of Parkinson's Disease Patients by Interpreting Texts
Trial Acronym
STOP-IT
URL of the Trial
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Brief Summary in Lay Language
Speech disturbances and reduced intelligibility are a common problem of advanced Parkinson’s disease patients. Therefore, patients often avoid communicating which results in a severe impairment of quality of life. This randomized controlled trial is designed to develop new concepts in speech therapy to improve intelligibility and communication-based quality of life in Parkinson’s disease patients with hypophonic dysarthria.
Brief Summary in Scientific Language
Parkinson’s disease (PD) is a progressive neurological disorder which impairs all aspects of speech and voice resulting in hypophonic dysarthria in more than 80% of patients. The loss of intelligibility considerably impacts on activities of daily life and thereby also on the desire to communicate. In this randomized controlled study new concepts of speech therapy based on text interpretation will be analysed in patients with advanced PD and dysarthria. They received either two weeks of a daily treatment with focus on phonation, respiration, articulation and prosody or two weeks of a daily treatment following fundamentals of oral interpretation and performance. Patients in the control group were put on a waiting list for at least three months. Changes in intelligibility as primary outcome parameter will be evaluated by blinded listeners on the level of words, sentences, texts and spontaneous speech directly following the training as well as after a period of 3 months. As secondary outcome parameters changes in self-perception and assessment by others as well as alterations in communication-based quality of life will be investigated. Additionally, acoustic parameters will be evaluated.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00006333
- 2014/07/22
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- yes
- Approved
- 3863-08/13, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
Secondary IDs
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Health Condition or Problem studied
- G20 - Parkinson disease
Interventions/Observational Groups
- Speech and voice treatment focussing respiration, articulation and phonation, 8 training sessions (45 min) over a period of 2 weeks
- Speech and voice treatment focussing fundamentals of oral interpretation and performance, 8 training sessions (45 min) over a period of 2 weeks
- Control (no treatment, admission to a waiting list)
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- assessor, data analyst
- Active control, No treatment
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
Changes in intelligibility on the level of words, sentencesand texts as well as in spontaneous speech one day after the last training session and 3 months later (assessment by blinded listeners)
Secondary Outcome
Changes in self perception and perception by others according to the voice handicap index (VHI), communication-related quality of life (PDQ-39), changes in acoustic parameters one day after the last training session as well as 3 months later
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2013/09/30
- 30
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 40 Years
- 85 Years
Additional Inclusion Criteria
Parkinson's disease (Brain Bank criteria, Hoehn & Yahr stage 2 - 4) with hypophonic dysarthria
Exclusion Criteria
Presence of dementia or atypical Parkinson's disease, ongoing speech therapy during the trial, text blindness
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Jena
- Bachstraße 18
- 07740 Jena
- Germany
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- [---]*
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- http://www.uniklinikum-jena.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Hans-Berger- Klinik für Neurologie, Universitätsklinikum Jena
- Mr. Prof. Dr. med. Christoph Redecker
- Erlanger Allee 101
- 07747 Jena
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 3641 9323430
- +49 3641 9323412
- christoph.redecker at med.uni-jena.de
- http://www.neuro.uniklinikum-jena.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address scientific-contact
- Institut für Germanistische Sprachwissenschaft, Friedrich-Schiller-Universität Jena
- Mr. Prof. Dr. phil. Adrian P. Simpson
- Fürstengraben 30
- 07743 Jena
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 3641 944310
- +49 3641 944312
- adrian.simpson at uni-jena.de
- http://www.sprechwissenschaft.uni-jena.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Hans-Berger- Klinik für Neurologie, Universitätsklinikum Jena
- Mr. Prof. Dr. med. Christoph Redecker
- Erlanger Allee 101
- 07747 Jena
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 3641 9323430
- +49 3641 9323412
- christoph.redecker at med.uni-jena.de
- http://www.neuro.uniklinikum-jena.de
end of 1:1-Block address contact public-contact -
start of 1:1-Block address public-contact
- Institut für Germanistische Sprachwissenschaft, Friedrich-Schiller-Universität Jena
- Ms. Dr. phil. Beate Redecker
- Fürstengraben 30
- 07743 Jena
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 3641 944337
- +49 3641 944312
- beate.redecker at uni-jena.de
- http://www.sprechwissenschaft.uni-jena.de
end of 1:1-Block address contact public-contact -
start of 1:1-Block address public-contact
- Institut für Germanistische Sprachwissenschaft, Friedrich-Schiller-Universität Jena
- Ms. Dr. phil. Sara Neuhauser
- Fürstengraben 30
- 07743 Jena
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 3641 944028
- +49 3641 944312
- sara.neuhauser at uni-jena.de
- http://www.sprechwissenschaft.uni-jena.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Jena
- Bachstraße 18
- 07740 Jena
- Germany
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- http://www.uniklinikum-jena.de
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
- Redecker B, Neuhauser S, Simpson AP, Redecker C. Speech and voice treatment with literary texts in advanced Parkinson's disease patients: assessment of intelligibility and acoustic changes. Poster, 18th International Congress of Parkinson's Disease and Movement Disorders 2014, Stockholm.
- Redecker B, Neuhauser S, Simpson AP, Redecker C. Assessing intelligibility and acoustic changes in individuals with advanced Parkinson's disease: a pre-/ post-treatment study. Poster, 15th International Clinical Phonetics and Linguistics Association Conference 2014, Stockholm.