demarpark: Assisted Device for Freezing in Parkinson Disease

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT02317289

Collaborator

(none)

Enrollment

Location

Arm

16.2

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Detection of freezing	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Development of a Multimodal Controlled Device for Improvement and Monitoring of Freezing in Parkinsonian Patients

Actual Study Start Date :

Jun 6, 2014

Actual Primary Completion Date :

Oct 13, 2015

Actual Study Completion Date :

Oct 13, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Detection of freezing freezing parkinsonian patients	Device: Detection of freezing single wireless inertial sensor placed on the patients's lower limbs to detect freezing of gaitin Parkinsonian patients Other Names: SENSBIO

Arm

Intervention/Treatment

Experimental: Detection of freezing

freezing parkinsonian patients

Device: Detection of freezing

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

Other Names:

SENSBIO

Outcome Measures

Primary Outcome Measures

fog score [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

troublesome freezing

Exclusion Criteria:

dementia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gui de Chauliac Hospital	Montpellier		France	34090

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Principal Investigator: Christian GENY, MD, CHRU Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT02317289

Other Study ID Numbers:

9096

First Posted:

Dec 15, 2014

Last Update Posted:

Dec 28, 2021

Last Verified:

Dec 1, 2021

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Dec 28, 2021