Assisted Device for Freezing in Parkinson Disease

NCT ID: NCT02317289

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-06
• Study Completion Date: 2015-10-13

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Detection of freezing

freezing parkinsonian patients

Group Type: EXPERIMENTAL

Detection of freezing

Intervention Type: DEVICE

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

Interventions

Detection of freezing

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

Intervention Type: DEVICE

Other Intervention Names

SENSBIO

Eligibility Criteria

Inclusion Criteria

• troublesome freezing

Exclusion Criteria

• dementia

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian GENY, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Montpellier

Locations

Gui de Chauliac Hospital

Montpellier, , France

Countries

France

Other Identifiers

9096

Identifier Type: -

Identifier Source: org_study_id