Pragmatic randomized controlled study to evaluate the clinical and biological effectiveness of the Parkinson's Disease Multimodal Complex Treatment (ProACT)

Pragmatic randomized controlled study to evaluate the clinical and biological effectiveness of the Parkinson's Disease Multimodal Complex Treatment (ProACT) - ProACT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032619

Enrollment

114

Registered

2023-09-13

Start date

2023-12-31

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20

Interventions

Group 1: Intervention group: Multidisciplinary inpatient Parkinson's Disease Multimodal Complex Treatment (OPS Code 8-97d) Group 2: Control group: Outpatient care as usual

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- Health-related quality of life: EQ-5D-5L; EQ- VAS - Activities of daily living: Movement Disorder Society Unified Parkinson's Disease Rating Scale, Part II (MDS-UPDRS II) - Motor symptoms: MDS-UPDRS III-IV; Purdue Pegboard Test (PPT). - Axial motor functions: Timed Up and Go Test (TUG); 20-m-Straight walk, single and dual task conditions; Berg Balance Scale (BBS); Falls Efficacy Scale (FES-I) - Non-motor symptoms: MDS-UPDRS I; Beck Depression Inventory (BDI-II) - Cognition: Montreal Cognitive Assessment (MoCA) - Global measure of treatment effect: Patient's/Clinician's Global Impression of Change (PGIC, CGIC) - Therapy Adherence: Morisky Medication Adherence Scale (MMAS-8) - Physical Activity Behavior: International Physical Activity Questionnaire (IPAQ) - Health care utilization: Questionnaire on the use of medical and non-medical care services in old age (FIMA) - Satisfaction with discharge management: Care Transitions Measure (CTM-15) - Satisfaction with inpatient stay (HCAHPS) - Complications: e.g., falls, infections - Caregiver Burden: Zarit Burden Interview (ZBI) - Sensor-based gait and balance parameters (e.g. step length, gait speed), RehaGait® (Hasomed, Magdeburg) under supervised conditions in the clinic - sensor-based movement parameters, AX6 (Axivity, Newcastle upon Tyne, UK) or MoveMonitor (McRobert's, The Hague, Netherlands) under non-supervised conditions during one-week home assessment after T0, after T2 and before T4 - blood biomarkers neuroinflammation, neurodegeneration, neuroregeneration - Immunophenotyping of PBMCs	—

Measure

Time frame

- Health-related quality of life: EQ-5D-5L; EQ- VAS - Activities of daily living: Movement Disorder Society Unified Parkinson's Disease Rating Scale, Part II (MDS-UPDRS II) - Motor symptoms: MDS-UPDRS III-IV; Purdue Pegboard Test (PPT). - Axial motor functions: Timed Up and Go Test (TUG); 20-m-Straight walk, single and dual task conditions; Berg Balance Scale (BBS); Falls Efficacy Scale (FES-I) - Non-motor symptoms: MDS-UPDRS I; Beck Depression Inventory (BDI-II) - Cognition: Montreal Cognitive Assessment (MoCA) - Global measure of treatment effect: Patient's/Clinician's Global Impression of Change (PGIC, CGIC) - Therapy Adherence: Morisky Medication Adherence Scale (MMAS-8) - Physical Activity Behavior: International Physical Activity Questionnaire (IPAQ) - Health care utilization: Questionnaire on the use of medical and non-medical care services in old age (FIMA) - Satisfaction with discharge management: Care Transitions Measure (CTM-15) - Satisfaction with inpatient stay (HCAHPS) - Complications: e.g., falls, infections - Caregiver Burden: Zarit Burden Interview (ZBI) - Sensor-based gait and balance parameters (e.g. step length, gait speed), RehaGait® (Hasomed, Magdeburg) under supervised conditions in the clinic - sensor-based movement parameters, AX6 (Axivity, Newcastle upon Tyne, UK) or MoveMonitor (McRobert's, The Hague, Netherlands) under non-supervised conditions during one-week home assessment after T0, after T2 and before T4 - blood biomarkers neuroinflammation, neurodegeneration, neuroregeneration - Immunophenotyping of PBMCs

—

Countries

Germany

Contacts

Public ContactAnnika Horstmann

Universitätsklinik für Neurologie der Ruhr-Universität Bochum am St. Josef-Hospital Bochum

annika.horstmann@rub.de023450959018

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026