Assisted Device for Freezing in Parkinson Disease

Parkinson Disease Clinical Trial

— demarpark  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02317289
• Other study ID #: 9096
• Status: Terminated
• Phase: N/A
• Start date: June 6, 2014
• Est. completion date: October 13, 2015

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: October 13, 2015
• Est. primary completion date: October 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• troublesome freezing

Exclusion Criteria:

• dementia

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
France	Gui de Chauliac Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fog score		1 day