Trial document




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  DRKS00000730

Trial Description

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Title

BIG therapy in Parkinson's disease: dose response relations

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Trial Acronym

BIGdr study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

„BIG-Therapy in Parkinson's disease: Dose-Response Realtion“

BIG is a new physiotherapeutic approach for thetraetment of Parkinson's disease (PD). Yet, classical BIG training is time-consuming. The main focus of BIG is intensive training of large amplitude movements.

Participants will be randomly allocated to one of two groups:
1. BIG classic: 16 hours of training within 4 weeks
2. BIG short version: 10 hours of training within 2 weeks.
Participants should be diagnosed with Parkinson's disease in mild to moderate stages.

The present study aims to assess the effects of a shorter training (10 hours) compared to the classical BIG training.

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Brief Summary in Scientific Language

„BIG-Therapy in Parkinson's disease: Dose-Response Realtion“

1.1.BIG is a new physiotherapeutic approach for the treatment of Parkinson's disease (PD). The main focus of BIG is intensive training of large amplitude movements. Classical BIG training is time-consuming (16 hours). The presnt study aims to assess the effects of a shorter training (10 hours)

1.2.1. Primary endpoint
UPDRS-Motor-Score (Part III) in ON-state (Rater blinded video-rating).

1.2.2.secondary endpoints
Quality of life (PDQ-39),
ADL (UPDRS Part II),
cognitive function (TAP)
Motivation (Paremo-20)
Gait analysis (Hasomed)
6-min-walk-Test,
stand-walk-sit-Test,
Box & Block-Test.

1.3. Schedule

Start screening: March 2011
Start baseline 1 April 2011
Start therapy Mai 2011
last patient in 10/2011
last follow-up 01/2012

1.4. Facilities

· Fachkrankenhaus für Bewegungsstörungen Beelitz Heilstätten, Paracelsusring 6a, 14547 Beelitz-Heilstätten
· KG Praxis H.Unger, Johannisberger Str. 1, 14197 Berlin

2. Subjects and Methods

2.1.Subjects

2.1.1. Inclusion Criteria·
Idiopathic ParkinsonStage Hoehn & Yahr I-III
· UPDRS-Motor-Score (III) 12 or more comprising at least 6 points on bradykinesia-items

2.1.2. Ausschlusskriterien
· Dementia(MMSE < 20)
· Severe Depression
· Severe Dyskinesia when ON
· Motor impairment due zto other diseases
Reduced abilizty to practice due to cardiac or other diseases

2.1.3. Recruitment
Fachkrankenhaus für Bewegungsstörungen / Parkinson Beelitz-Heilstätten

2.1.4. Randomisation
50/50 randomisation according to random numbers (lots)

2.1.5. Rater-blinding
Blinded video rating of UPDRS

2.2. Definition of intervention

2.2.1. BIG (classic)
16 sessions within 4 weeks, lasting 1 hr each

2.2.2. BIG (short)
10 sessions within 2 weeks, lasting 1hr each

2.3. Evaluation

2.3.1. UPDRS III Videoanalysis
4 weeks before initiation of therapy, immediately before start (baseline), immediately after cessation of training, 16 weeks after initiation of training.

2.3.2. secondary endpoints
concommitantly with assessment of primary variable

2.4. Statistics

2.4.1. Descriptive statistics
All parameters will be entered into a database.

2.4.2. Comparative statistics
ANOVA for repeated measures. Post hoc testing with parametric tests in case of significance ( < .05).


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Organizational Data

  •   DRKS00000730
  •   2011/04/19
  •   [---]*
  •   yes
  •   Approved
  •   S 6(a)/2011, Ethik-Kommission der Landesärztekammer Brandenburg
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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

  •   BIG therapy classic (16 hrs / 4weeks)
  •   BIG therapy short version (10hrs/2 weeks)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

UPDRS-Motor-Score (Sum score of all itemns of UPDRS Part III) in ON-state (Rater blinded video-rating) at baseline, 4 weeks, 8 weeks and 16 weeks. UODRS part III is the international standard for the assessment of motor performance in PD.

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Secondary Outcome

Quality of life (PDQ-39),
ADL (UPDRS Part II),
cognitive function (TAP)
Motivation (Paremo-20)
Gait analysis (Hasomed) and timed-tests
(6-min-walk-Test,
stand-walk-sit-Test,
Box & Block-Test) will be assessed at baseline and at 16 weeks follow-up. Walking velocity will be measured by manual stopwatch on a 20m indoor parcours. The stand-walk-sit test comprises raising from a chair- walking 5m-turn-walking back 5m-sit down.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/04/20
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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


Idiopathic Parkinson Stage Hoehn & Yahr I-III
· UPDRS-Motor-Score (III) 12 or more comprising at least 6 points on bradykinesia-items.
Ambulatory without walking-aids.
Willingness to participate in a randomized study.
Sufficient time and mobility for intensive out-patient-treatment

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Exclusion Criteria

· Dementia(MMSE < 20)
· Severe Depression
· Severe Dyskinesia when ON
· Motor impairment due zto other diseases
· Reduced abilizty to practice due to cardiac or other diseases

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Addresses

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    • Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson
    • Mr.  PD Dr. med.  Georg  Ebersbach 
    • Paracelsusring 6a
    • 14547  Beelitz-Heilstätten
    • Germany
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    • Deutsche Parkinson Vereinigung e.V.
    • Mr. 
    • Moselstrasse 31
    • 41464   Neuss
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Mr.  PD Dr.  Georg  Ebersbach 
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  • start of 1:1-Block address public-contact
    • Mr.  PD DR.  Georg  Ebersbach 
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Sources of Monetary or Material Support

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    • Deutsche Parkinson Vereinigung e.V.
    • Moselstrasse 31
    • 41464   Neuss
    • 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.