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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02356536
Registration number
NCT02356536
Ethics application status
Date submitted
28/01/2015
Date registered
5/02/2015
Date last updated
14/08/2017
Titles & IDs
Public title
The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease
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Scientific title
The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease
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Secondary ID [1]
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2013000952
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Universal Trial Number (UTN)
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Trial acronym
CuePed
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gait Disorders, Neurologic
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Condition category
Condition code
Neurological
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Parkinson's disease
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Agilitas
Experimental: Experimental -
Treatment: Devices: Agilitas
WCD trial
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total seconds of FOG
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Assessment method [1]
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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
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Timepoint [1]
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2 weeks
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Eligibility
Key inclusion criteria
* Parkinson's Disease, clinically significant freezing of gait, no significant medical comorbidities
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Minimum age
40
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Non-english speaking, dementia, wheelchair or mobility aid dependent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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4000 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT02356536
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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rodney i marsh, MBBS
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02356536
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