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PDnetGo - a multicenter, European RCT study to evaluate a hybrid analog/digital care solution for Parkinson's patients

PDnetGo - a multicenter, European RCT study to evaluate a hybrid analog/digital care solution for Parkinson's patients - PDnetGo Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034945
Enrollment
120
Registered
2024-10-31
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

G20.1

Interventions

Group 1: intervention: Usage of the “Parkinson Go TM” digital care system in addition to standard therapy for Parkinson's patients (standard therapy = recent medication plan and on-site physiotherapy

Sponsors

Portabiles Healthcare Technologies GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Parkinson's disease, clinically confirmed diagnosis by neurology specialist • Duration of disease = 2 years • MDS-UPDRS III = 13 points in the medicated ON state • Need for optimization, especially gait instability/bradykinesia present • Inclusion possible in case of fluctuations in effect (UPDRS IV = 50% of the day) • Routine smartphone usage in everyday life • Free walking possible for at least 4 x 10m • Sufficient motivation on the part of the patient to use medication/physiotherapy/app/teletherapy

Exclusion criteria

Exclusion criteria: • Initial medication • (Leading) alternative causes of gait/balance disorder (PNP, spinal stenosis, post-stroke spasticity, post-stroke paralysis, vestibular disorder, ataxia, acute musculoskeletal disorders) • Severe visual/reading impairment, hypacusis (teleconsultation) • MMST = 26 points • Lack of affinity for technology, excessive demands with smartphones/smart technologies in everyday life • Planned hospital stays/vacations during the first 2 weeks of app use (mandatory) • Planned hospital stays/vacations Study duration (exception: sensors can be worn as planned and video exercises can be continued consistently) • Serious side effects (hallucinations, impulse control disorder, sleep attacks) that require an acute adjustment of medication • Participation in another intervention study

Design outcomes

Primary

MeasureTime frame
Health status/mobility is assessed using the standardized motor section of the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) at the time of the inclusion visit and after 3 months at the exclusion visit

Secondary

MeasureTime frame
Gait quality (Functional Gait Assessment Score = FGA-Score, Activity Balance Confidence Scale = ABC-Scale), quality of life (Parkinson's Disease Questionnaire = PDQ-39), usability tele-service (System Usability Scale = SUS), health economic evaluation (own questionnaire, survey of outpatient-sensitive cases of illness and care-sensitive cases of illness)

Countries

France, Germany, Spain

Contacts

Public ContactSabine Stallforth

Abteilung für Molekulare Neurologie Universitätsklinik Erlangen

sabine.stallforth@uk-erlangen.de+4991318544678

Outcome results

None listed

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