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

Not Applicable

Completed

• Conditions: Parkinson Disease; Healthy Volunteers
• Interventions: Drug: Levodopa acute challenge; Other: Controlled environment tests (series of tasks of everyday life); Device: ActiMyo recording; Other: Diary completion

• Registration Number: NCT02785978
• Lead Sponsor: Institut de Myologie, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-05-30
• Study Start: 2016-06
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson Disease Patients Group #1	Controlled environment tests (series of tasks of everyday life)	PD patients with programmed levodopa challenge
Parkinson Disease Patients Group #1	ActiMyo recording	PD patients with programmed levodopa challenge
Parkinson Disease Patients Group #1	Diary completion	PD patients with programmed levodopa challenge
Parkinson Disease Patients Group #2	Controlled environment tests (series of tasks of everyday life)	PD patients without programmed levodopa challenge
Parkinson Disease Patients Group #2	ActiMyo recording	PD patients without programmed levodopa challenge
Parkinson Disease Patients Group #2	Diary completion	PD patients without programmed levodopa challenge
Healthy volunteers	Controlled environment tests (series of tasks of everyday life)	Healthy volunteers
Healthy volunteers	Diary completion	Healthy volunteers
Healthy volunteers	ActiMyo recording	Healthy volunteers
Parkinson Disease Patients Group #1	Levodopa acute challenge	PD patients with programmed levodopa challenge

Primary Outcome Measures

Name	Time	Method
Tremors measurement by ActiMyo®	Baseline	PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation.
Small steps measurement by ActiMyo®	Baseline	PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation.
Dyskinesia measurement by ActiMyo®	Baseline	PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Dyskinesia will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation.

Secondary Outcome Measures

Name	Time	Method
Continuous home activity measurement by ActiMyo®	2 weeks	Subjects (PD patients and healthy volunteers) will wear ActiMyo® sensors everyday during 2 weeks and complete a hand-written paper diary to record their activity.; Activity variables will be deduced from ActiMyo® raw data analysis.
Everyday life tasks measurement by ActiMyo®	Baseline	PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis.
Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo®	2 weeks	PD patients will wear ActiMyo® sensors everyday during 2 weeks and complete a hand-written paper diary to record their state (Off, On without dyskinesia, on with dyskinesia).; Off, On without dyskinesia, on with dyskinesia states will be measured following ActiMyo® raw data analysis and compared to hand-written paper diary indicating states.

Trial Locations

Locations (3)

Association Institut de Myologie; 🇫🇷 Paris, France

Département des Maladies du Système Nerveux, GH Pitie Salpatriere; 🇫🇷 Paris, France

Service de Neurochirurgie, Hopital Henri Mondor; 🇫🇷 Creteil, France