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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease
Scientific title
The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gait Disorders, Neurologic 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Neurological 0 0 0 0
Other neurological disorders

Study type
Description of intervention(s) / exposure
Treatment: Devices - Agilitas

Experimental: Experimental -

Treatment: Devices: Agilitas
WCD trial

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Total seconds of FOG - 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
Timepoint [1] 0 0
2 weeks

Key inclusion criteria
- Parkinson's Disease, clinically significant freezing of gait, no significant medical
Minimum age
40 Years
Maximum age
90 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Non-english speaking, dementia, wheelchair or mobility aid dependent

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane

Funding & Sponsors
Primary sponsor type
The University of Queensland

Ethics approval
Ethics application status

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 website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
rodney i marsh, MBBS
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications