COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease
Secondary ID [1] 0 0
2013000952
Universal Trial Number (UTN)
Trial acronym
CuePed
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Phase 1
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02356536
Trial related presentations / publications
Public notes

Contacts
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