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Assisted Device for Freezing in Parkinson Disease (demarpark)

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Detection of freezing
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • troublesome freezing

Exclusion Criteria:

  • dementia

Sites / Locations

  • Gui de Chauliac Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Detection of freezing

Arm Description

freezing parkinsonian patients

Outcomes

Primary Outcome Measures

fog score

Secondary Outcome Measures

Full Information

First Posted
December 3, 2014
Last Updated
December 27, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02317289
Brief Title
Assisted Device for Freezing in Parkinson Disease
Acronym
demarpark
Official Title
Development of a Multimodal Controlled Device for Improvement and Monitoring of Freezing in Parkinsonian Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
end of inclusion period and recruitment difficulties
Study Start Date
June 6, 2014 (Actual)
Primary Completion Date
October 13, 2015 (Actual)
Study Completion Date
October 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients .This brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk is associated to a fall risk. Automatized FOG episode detection would allow systematic assessment of patient state and objective evaluation of the clinical effects of treatments. Techniques have been proposed in the literature to identify FOG episodes based on the frequency properties of inertial sensor signals. Our objective here is to adapt and extend these FOG detectors in order to include other associated gait pattern changes, like festination. The proposed approach is based on a single wireless inertial sensor placed on the patient's lower limbs. Based freezing detectors are not sufficient to detect all FOG and festination episodes. Stride length and cadence are valuable inputs to anticipate the occurrence of upcoming FOG events. The investigators have developed a solution based on a minimal number of embedded sensors and detection algorithms for future real-time applications. It is well known that auditory rhythmic stimulation or visuals marks on the ground would improve dramatically gait in patients with FOG. This sensibility to cueing leads some teams to develop some mobility aid devices rhythmic. Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Detection of freezing
Arm Type
Experimental
Arm Description
freezing parkinsonian patients
Intervention Type
Device
Intervention Name(s)
Detection of freezing
Other Intervention Name(s)
SENSBIO
Intervention Description
single wireless inertial sensor placed on the patients's lower limbs to detect freezing of gaitin Parkinsonian patients
Primary Outcome Measure Information:
Title
fog score
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: troublesome freezing Exclusion Criteria: dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian GENY, MD
Organizational Affiliation
CHRU Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gui de Chauliac Hospital
City
Montpellier
ZIP/Postal Code
34090
Country
France

12. IPD Sharing Statement

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Assisted Device for Freezing in Parkinson Disease

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