Trial document




This trial has been registered retrospectively.
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  DRKS00006333

Trial Description

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Title

Speech Therapy of Parkinson's Disease Patients by Interpreting Texts

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Trial Acronym

STOP-IT

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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.

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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.

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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
  •   [---]*
  •   yes
  •   Approved
  •   3863-08/13, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G20 -  Parkinson disease
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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)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control, No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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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)

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/09/30
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   85   Years
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Additional Inclusion Criteria

Parkinson's disease (Brain Bank criteria, Hoehn & Yahr stage 2 - 4) with hypophonic dysarthria

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Exclusion Criteria

Presence of dementia or atypical Parkinson's disease, ongoing speech therapy during the trial, text blindness

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Hans-Berger- Klinik für Neurologie, Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Christoph  Redecker 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Institut für Germanistische Sprachwissenschaft, Friedrich-Schiller-Universität Jena
    • Mr.  Prof. Dr. phil.  Adrian P.  Simpson 
    • Fürstengraben 30
    • 07743  Jena
    • Germany
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    • Hans-Berger- Klinik für Neurologie, Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Christoph  Redecker 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Institut für Germanistische Sprachwissenschaft, Friedrich-Schiller-Universität Jena
    • Ms.  Dr. phil.  Beate  Redecker 
    • Fürstengraben 30
    • 07743  Jena
    • Germany
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    • Institut für Germanistische Sprachwissenschaft, Friedrich-Schiller-Universität Jena
    • Ms.  Dr. phil.  Sara  Neuhauser 
    • Fürstengraben 30
    • 07743  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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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.
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* This entry means the parameter is not applicable or has not been set.