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
About this trial
This is an interventional prevention trial for Parkinson Disease
Eligibility Criteria
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
NCT ID
NCT02317289
First Posted
December 3, 2014
Last Updated
December 27, 2021
Sponsor
University Hospital, Montpellier
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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