Pragmatic randomized controlled study to evaluate the clinical and biological effectiveness of the Parkinson's Disease Multimodal Complex Treatment (ProACT)
Not Applicable
Recruiting
- Conditions
- G20Parkinson disease
- Registration Number
- DRKS00032619
- Lead Sponsor
- niversitätsklinik für Neurologie der Ruhr-Universität Bochum am St. Josef-Hospital Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
1. Majority (minimum age of 18 years)
2. Ability to be informed
3. Ability to consent
4. Diagnosis of at least probable PD according to the Diagnostic Criteria of the Movement Disorder Society (Postuma et al., 2015)
5. Modified disease stage according to Hoehn and Yahr (HY) of 1-4
6. Presence of an elective indication for PD-MCT
7. Place on the hospital's internal PKT waiting list that is more than seven months in the future
Exclusion Criteria
1. Diagnosis of atypical or symptomatic Parkinsonian syndrome
2. Presence of a non-elective indication for PD-MCT
3. Severe dementia or psychotic syndrome as assessed by the investigator
4. Difficulties in meeting the study requirements
5. Logistical reasons
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health-related quality of life (PDQ-39), change in mean PDQ-39 summary index at discharge (T2; IG) and 6 weeks after baseline (T2; KG), respectively, compared to baseline (T0)
- Secondary Outcome Measures
Name Time Method