Clinical Trial: The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease

Brief Summary: The CuePeD trial is an intervention trial measuring the effectiveness of a novel treatment for Freezing of Gait (FOG) in Parkinson's disease (PD). The primary intervention is the use of a wearable cueing device (WCD), which detects and responds to FOG and extinguishes on the resumption of normal walking. It is designed for use in PD patients with FOG, in their home environment where FOG is most severe. Kinematic data will be logged by a memory card in the belt worn device recording FOG, and falls. The device will be used on 3 different settings in a gait laboratory environment, and then for 2 weeks in the patient's own home using the same 3 settings. A battery of psychometric instruments will be administered before and after the trial

Detailed Summary:

The CuePeD trial primarily involves the use of a WCD ( pictured on website www.brightdevices.com.au). This is a belt worn device, with a co-location of motion sensor input and cueing output. The input is mediated by miniaturized accelerometers and gyroscopes and utilizes software algorithms which have been developed to detect FOG. The cueing output is mediated by a laser light which shines on the floor in front of the user as a continuous visual signal. The cue is produced because of the device's ability to recognize FOG in the user. The laser is produced for a predetermined period of time or until normal gait is recommenced, at which time it extinguishes until the next freezing episode.

This study plans to examine the effectiveness of the WCD for the problem of FOG in PD 'in vivo', that is, in a community setting.

FOG has been defined narrowly as 'the sudden inability to initiate or sustain locomotion'. It includes 'start', 'turn' and 'destination' hesitation. A broader definition accepted at the 2010 workshop of clinicians and scientists interested in FOG was " brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk" . It generally occurs several years after the onset of PD and has been recognized as a significant source of morbidity in PD patients. Cueing represents one of the more promising treatments, but the demonstration of in vivo effectiveness of this intervention to date, are modest.

Falls, while often multifactorial in a general population, in PD are often attributable to FOG.

Unfortunately, current treatments for FOG are largely ineffective, and the evidence for their use limited.

Interventions for FOG
Sponsor: The University of Queensland

Current Primary Outcome: Total seconds of FOG [ Time Frame: 2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Queensland

Dates:
Date Received: January 28, 2015
Date Started: October 2013
Date Completion: December 2015
Last Updated: February 4, 2015
Last Verified: February 2015