Trial document
DRKS00014952
Trial Description
Title
Individualized training program for Parkinson's patients
Trial Acronym
ParkProTrain
URL of the Trial
[---]*
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.
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.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
Included patients were assured that no data would be passed on.
Organizational Data
- DRKS00014952
- 2018/06/20
- [---]*
- yes
- Approved
- 18-138, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
Secondary IDs
- [---]*
Health Condition or Problem studied
- G20.0 - [generalization G20: Parkinson disease]
- G20.1 - [generalization G20: Parkinson disease]
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.
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Open (masking not used)
- [---]*
- Active control (effective treament of control group)
- Supportive care
- Other
- N/A
- N/A
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.
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.
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2018/09/06
- 200
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Parkinson's Disease
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
Addresses
-
start of 1:1-Block address primary-sponsor
- Institut für Sozialmedizin und Epidemiologie der Universität zu Lübeck
- 23538 Lübeck
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Segeberger Kliniken, Neurologisches zentrum
- Prof. Dr. Björn Hauptmann
- Hamdorfer Weg 3
- 23795 Bad Segeberg
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 04551 802 - 6853
- [---]*
- bjoern.hauptmann at segebergerkliniken.de
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Institut für Telematik, Universität zu Lübeck
- Mr. Prof. Dr. Andreas Schrader
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address other
- Institut für Multimediale und Interaktive Systeme, Universität zu Lübeck
- Ms. Prof. Dr. Nicole Jochems
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Institut für Sozialmedizin und Epidemiologie, Universität Lübeck
- Prof. Dr. Ruth Deck
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0451 50051211
- [---]*
- ruth.deck at uksh.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Institut für Sozialmedizin und Epidemiologie, Universität Lübeck
- Prof. Dr. Ruth Deck
- Ratzeburger Allee 160
- 23538 Lübeck
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0451 50051211
- [---]*
- ruth.deck at uksh.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Gemeinsamer Bundesausschuss G-BA
- 10623 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- [---]*
- [---]*
- 2021/06/30
- 234
- 234