NCT02785978

Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institut de Myologie, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo measured activity in PD patients. The purpose of the study is to provide validation of the ActiMyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for PD patient care.

Conditions

• Parkinson Disease
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Levodopa acute challenge	Inclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring
OTHER	Controlled environment tests (series of tasks of everyday life)	Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life)
OTHER	Standardized scales: MDS-UPDRS (Part II to IV) and RDRS	Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
DEVICE	ActiMyo recording	Continuous activity recording with ActiMyo during the 2 weeks of study participation
OTHER	Diary completion	Daily patient logbook completion during the 2 weeks of study participation

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2016-05-30
• Last updated: 2017-10-10

Locations

3 sites across 1 country: France