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The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease (CuePed)

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ClinicalTrials.gov Identifier: NCT02356536
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
rodney marsh, The University of Queensland

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

Condition or disease Intervention/treatment Phase
Gait Disorders, Neurologic Device: Agilitas Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease
Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Device: Agilitas
WCD trial




Primary Outcome Measures :
  1. Total seconds of FOG [ Time Frame: 2 weeks ]

    duration of freezing with device on versus During the 2 week home trial, Kinematic data to capture FOG duration will be logged on the device during the same time period each day with the device on different settings. Fall data will collected from 6am to 10pm.

    FOG episodes on all 3 settings of the device will be recorded. The primary outcome measure will be the total seconds of FOG when the device is simply recording compared with the total FOG seconds when a FOG dependent ( or continuous FOG independent) cue is provided by the device. This will be recorded by means of a microSD card within the device. The data will be downloaded once the device is returned




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's Disease, clinically significant freezing of gait, no significant medical comorbidities

Exclusion Criteria:

  • Non-english speaking, dementia, wheelchair or mobility aid dependent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356536


Locations
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Australia, Queensland
University of Queensland
Brisbane, Queensland, Australia, 4000
Sponsors and Collaborators
The University of Queensland
Investigators
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Principal Investigator: rodney i marsh, MBBS The University of Queensland
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Responsible Party: rodney marsh, Dr, The University of Queensland
ClinicalTrials.gov Identifier: NCT02356536    
Other Study ID Numbers: 2013000952
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Gait Disorders, Neurologic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations