Trial document




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  DRKS00009288

Trial Description

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Title

The central facial paresis after stroke: a randomised control study

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Trial Acronym

FaPaS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with a central facialis paresis (CFP) after stroke are limited in drinking, eating and speech. In these patients the perception of socially relevant facial expressions is also limited. Thereafter, a successful interpersonal communication is limited considering facial mimicry with a negative interaction. “The Mundmotork training” (MMT) with repetitive facial muscle movement is usually applied to improve CFP. In this study we are interested whether an additional use of mirror training or taping to an additional MMT to usually applied MMT is more effective.

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Brief Summary in Scientific Language

In this randomized controlled study, patients with facial paresis after stroke will be compared between groups who additionally to a daily MMT of 30min (from Tuesday to Friday), will be applied a mirror training (4 days with a daily 30min training time) or taping (of the affected facial muscles) or an additional MMT (daily 30min for 4 days) to a group with only MMT once a day (30min from Tuesday to Friday). The time duration of training program is three weeks.

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Organizational Data

  •   DRKS00009288
  •   2015/08/28
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  •   yes
  •   Approved
  •   4432-05/14, 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

  •   I63.3 -  Cerebral infarction due to thrombosis of cerebral arteries
  •   central facialis paresis
  •   G51.0 -  Bell palsy
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Interventions/Observational Groups

  •   Additionally to a daily "Mundmotoriktraining" of 30min (daily for 4 days), a mirror training (4 days with a daily 30min training time) wii be apllied.
  •   Additionally to a daily "Mundmotoriktraining" of 30min (daily for 4 days), an additional MMT (daily 30min for 4 days) will be apllied.
  •   Additionally to a daily "Mundmotoriktraining" of 30min (daily for 4 days), the affected facial muscles will be taped.
  •   Control group will be trained once a day for 30min Mundmotoriktraining from Tuesday to Friday.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

pre-post difference of the House-Brackmann-Scale (scale with different level of symptoms of the faciale parese)

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Secondary Outcome

Facial Clinimetric Evaluation (FaCE) questionary before and after the intervention time

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/10/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

first ever stroke with facialis paresis within 7 days to 6 months after stroke

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Exclusion Criteria

-aphasia with comprehension deficits, who are not able to follow instructions
- affected brain in the past (e.g. brain injury)
- degenerative brain disease (e.g. parkinson)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Moritz Klinik Bad Klosterlausnitz
    • Mr.  Prof. Dr. med.  Farsin  Hamzei 
    • Hermann-Sachse Strasse 46
    • 07639  Bad Klosterlausnitz
    • Germany
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    • Moritz Klinik Bad Klosterlausnitz
    • Mr.  Prof. Dr. med.  Farsin  Hamzei 
    • Hermann-Sachse Strasse 46
    • 07639  Bad Klosterlausnitz
    • Germany
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    • Moritz Klinik Bad Klosterlausnitz
    • Mr.  Prof. Dr. med.  Farsin  Hamzei 
    • Hermann-Sachse Strasse 46
    • 07639  Bad Klosterlausnitz
    • Germany
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Sources of Monetary or Material Support

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    • Moritz Klinik
    • Mr.  Prof. Dr.   Frasin   Hamzei 
    • Hermann-Sachse Strasse 46
    • 07639  Bad Klosterlausnitz
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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