NCT02317289

Brief Summary

Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2015

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

December 3, 2014

Last Update Submit

December 27, 2021

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • fog score

    1 day

Study Arms (1)

Detection of freezing

EXPERIMENTAL

freezing parkinsonian patients

Device: Detection of freezing

Interventions

Detection of freezingDEVICE

single wireless inertial sensor placed on the patients's lower limbs to detect freezing of gaitin Parkinsonian patients

Also known as: SENSBIO
Detection of freezing

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • troublesome freezing

You may not qualify if:

  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gui de Chauliac Hospital

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Christian GENY, MD

    CHRU Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 15, 2014

Study Start

June 6, 2014

Primary Completion

October 13, 2015

Study Completion

October 13, 2015

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations

FR(1)