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Multiaxial data integration for continuous therapy adaption in neurological movement disorders and deep brain stimulation - substudy: patient reported outcomes via app

Multiaxial data integration for continuous therapy adaption in neurological movement disorders and deep brain stimulation - substudy: patient reported outcomes via app - MOVEBASE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023424
Enrollment
80
Registered
2021-03-25
Start date
2021-04-08
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: Clinical visit, that are performed, because automatic evaluation of app-data suggests relevant clinical deterioration Group 2: clinical visits, that are randomly triggered without suspicion o

Sponsors

Charité Campus Charité Mitte
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - definite diagosis of parkinsons disease - privately owned smartphone (Android or iOS operating system) and basic knowledge in using apps - able to understand study conditions and questiones asked in patient questionnaires

Exclusion criteria

Exclusion criteria: - cognitive deficites, that obviate fulfilling the inclusion criteria - comorbidities, whose influence on quality of life exceeds the influence of parkinsons disease considerably as rated by the study physician

Design outcomes

Primary

MeasureTime frame
Correlation coefficient with confidence interval between self-rated mobility on visual analogue scale within 2 weeks before study visit and MDS-UPDRS-III at the day of visit. Observation for 6 to 24 months per patient. Analysis: random intercept model

Secondary

MeasureTime frame
1) Correlation between self-rated general condition and QoL in PDQ-39-score as well as between step count and self-rated mobility (similar analysis to primary endpoint). 2) Sensitivity, specificity and predicitve values between gold standard (relevant deterioration/no relevant deterioration as determined in clinials visit) and independent variable (estimation from smartphone data). 3) Association between severity of clinical deterioration estimated in clinical visit or in smartphone app. 4) Changes in self-rating after therapeutic interventions.

Countries

Germany

Contacts

Public ContactAndrea Kühn

Klinik für Neurologie Charite - Universitätsmedizin Berlin

andrea.kuehn@charite.de030450660123

Outcome results

None listed

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