Trial document




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  DRKS00000070

Trial Description

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Title

A randomized, rater-blinded, single-center study with cross-over waitlist design to assess the efficacy of an anti-freezing training against motor blocks in Parkinsons's disease

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Freezing of gait (FOG) occurs often during the later stages of Parkinson's disease (PD) and mostly is refractory to medical intervention. This study with the methodology outlined in the titel, wants to proof the immediate effectiveness of a two-week physiotherapeutic intervention by drawing a comparison to a non-treated control group. The assessment tool for FOG is newly developped FOG-score.

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Brief Summary in Scientific Language

This is a single centre, rater-blinded randomized controlled cross-over study with a waiting list design to assess the efficacy of a 2 week anti-freezing-training with cueing against motor blocks during walking in Parkinson's disease.
The study consists of a screening to assess eligibility. After a stabilization period to rule out medication effects patients are randomized on either treatment or waiting list. The primary endpoint is to compare the Freezing-of-Gait-Score after two weeks in the treatment vs. the waiting group.
Treatment consists of a standardized anti-freezing program, including 6x30 min intensive cueing training.
A follow-up is requested in form of a quality-of-life questionnaire.

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Organizational Data

  •   DRKS00000070
  •   2009/02/05
  •   [---]*
  •   yes
  •   Approved
  •   2306/09, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson's disease
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Interventions/Observational Groups

  •   Arm 1: Two-week anti-freezing training with six training unit each lasting 30 min.
  •   Arm 2: Same intervention (Two-week anti-freezing training with six training unit each lasting 30 min), but begin after 2 weeks.
    (Cross-over waiting list design)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Other
  •   Crossover
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Primary Outcome

Freezing-of-Gait-Score at Visit 2, EARLY vs. LATE group

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/02/04
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Anamnestic Freezing of Gait
Diagnosis of idiopathic Parkinson's disease
Hoehn & Yahr Stadium <4
Able to walk outside for > 1 hr
Written informed consent

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Exclusion Criteria

Parkinsonism of other etiology
Clinically diagnosed dementia
Severe internal disease, eg. cardiac insufficiency
Severe orthopedic disease, eg. implant
Deep brain stimulation

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Addresses

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    • Neurologisches Krankenhaus München Zentrum für Parkinson und Bewegungsstörungen Schön Kliniken
    • Prof. Dr.  Andres  Ceballos-Baumann 
    • Parzivalplatz 4
    • 80804  München
    • Germany
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    • Neurologisches Krankenhaus München
    • Mr.  Dr. med.  Urban  Fietzek 
    • Parzivalplatz 4
    • 80804  München
    • Germany
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    • Neurologisches Krankenhaus München Schön Kliniken
    • Ms.  Frauke  Schroeteler 
    • Parzivalplatz 4
    • 80804  München
    • Germany
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    • Neurologisches Krankenhaus München Schön Kliniken
    • Ms.  Kerstin  Ziegler 
    • Parzivalplatz 4
    • 80804  München
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Parkinson Vereinigung e.V.
    • Beichstr. 3
    • 80802  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.