Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Summary
Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.
Timeline
- Start
- 2017-03-16
- Primary completion
- 2018-01-02
- Completion
- 2018-01-02
Outcome
Missed primary endpoint
registry analysis (superiority test); Rotigotine + Standard Care FAS vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS; p =0.134 NCT03103919 ↗
registry analysis (superiority test); Rotigotine + Standard Care FAS vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS; p =0.982 NCT03103919 ↗
registry analysis (superiority test); Rotigotine + Standard Care SS vs Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS; p =0.876 NCT03103919 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rotigotine | Unknown | 2 mg | — |
| Subject | Rotigotine | Unknown | 4 mg | — |