Trial document




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  DRKS00014952

Trial Description

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Title

Individualized training program for Parkinson's patients

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Trial Acronym

ParkProTrain

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Implementation of a tablet-based training program during and after in-patient Parkinson's complex treatment (PKB). It supports Parkinson's patients in continuing the physical-activating exercises learned in PKB under guidance and with regular adaptations independently and permanently in their everyday home life. It is expected to improve the quality of life and social participation and delay the progression of impairments.

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Brief Summary in Scientific Language

Methods: the training program for patients of the intervention group (IG) is developed as a tablet application (app). A mixed-methods study will be conducted.
A) Quasi-randomized, prospective longitudinal study (sequential study design). The IG receives the tablet-based training program during and for 9 months after the PKB, the control group (CG) receives the standard PKB and the standard treatment after PKB. The evaluation is carried out through a written survey at three points of measurement (beginning and end of PKB and after 9 months).
B) Qualitative analysis of interviews and focus groups regarding feasibility and acceptance
C) Formative evaluation of the app and the administration panel
D) Evaluation of the implementation of the training program through analysis of planned and completed physical activities and evaluation of telephone calls between physiotherapist and patient.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Included patients were assured that no data would be passed on.

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Organizational Data

  •   DRKS00014952
  •   2018/06/20
  •   [---]*
  •   yes
  •   Approved
  •   18-138, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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

  •   G20.0 -  [generalization G20: Parkinson disease]
  •   G20.1 -  [generalization G20: Parkinson disease]
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Interventions/Observational Groups

  •   Included are patients with idiopathic Parkinson’s syndrome in a special clinic. N=133 patients per IG (Intervention group) and KG (Control group) are included in the study. Both groups receive an individual medication as well as a treatment plan that is tailored to the prevailing symptoms of Parkinson's disease. IG patients additionally receive an individualized training program. The training program is being developed as a tablet application. The app contains Parkinson-specific exercises that are visually supported by videos. During the PKB (Parkinson's complex treatment), the tablet supports the body-activating therapy, at the end of the PKB, the patients set their personal training for the time after the PKB on the tablet. During the PKB, patients also take part in two patient-centered seminars. In the 9 months after PKB the training program is regularly adjusted by the patients together with the physiotherapist of the clinic. Patients fill in questionnaires at three times: before and after PKB as well as after 9 months.
  •   Patients of the control group receive an individual medication as well as a treatment plan that is tailored to the prevailing symptoms of Parkinson's disease.
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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)
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Parkinson Quality of Life Quationnaire (PDQ-8). Times of measurement: before and after PKB (Parkinson's complex treatment) als well as after 9 months.

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Secondary Outcome

Restrictions on participation, fear of falling, sleep disorders, anxiety and depression, pain. Times of measurement: before and after PKB (Parkinson's complex treatment) as well as after 9 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/09/06
  •   200
  •   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

Parkinson's Disease

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Exclusion Criteria

(MoCA) test <18 points, Berg Balance Scale <41 points, severe depressive episode, moderate to severe dementia, cardiovascular and orthopedic/surgical reasons that prevent self-training

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Addresses

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    • Institut für Sozialmedizin und Epidemiologie der Universität zu Lübeck
    • 23538  Lübeck
    • Germany
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    •   [---]*
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    • Segeberger Kliniken, Neurologisches zentrum
    • Prof. Dr.  Björn  Hauptmann 
    • Hamdorfer Weg 3
    • 23795  Bad Segeberg
    • Germany
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    • Institut für Telematik, Universität zu Lübeck
    • Mr.  Prof. Dr.  Andreas  Schrader 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Multimediale und Interaktive Systeme, Universität zu Lübeck
    • Ms.  Prof. Dr.  Nicole  Jochems 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Sozialmedizin und Epidemiologie, Universität Lübeck
    • Prof. Dr.  Ruth  Deck 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Sozialmedizin und Epidemiologie, Universität Lübeck
    • Prof. Dr.  Ruth  Deck 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss G-BA
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2021/06/30
  •   234
  •   234
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* This entry means the parameter is not applicable or has not been set.