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

NCT02785978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-10-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut de Myologie, France

    lead OTHER

Principal Investigators

  • Teresa Gidaro, MD, PhD · Association Institut de Myologie

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-30
Completion
2017-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785978 on ClinicalTrials.gov