Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000220662p
Ethics application status
Not yet submitted
Date submitted
14/02/2023
Date registered
2/03/2023
Date last updated
15/10/2023
Date data sharing statement initially provided
2/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of a handwriting app for diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.
Scientific title
A comparative clinical study of a handwriting app for the diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.
Secondary ID [1] 308922 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 328926 0
Condition category
Condition code
Neurological 325915 325915 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A digital tablet with a pressure-sensor mounted pen will be used to record the dynamics of handwriting and drawing. Hand writing tasks include drawing a guided Archimedean spiral with first the dominant and then non-dominant hands, using the dominant hand only, tracing 2 horizontal and 2 vertical lines; writing the letter "b" and "d" six times each; writing the letters "bd" six times; writing a short sentence; writing the participant's full name. It is anticipated that the activity will take approximately 10 minutes to complete over a single session.
Participants will attend a face-to-face session to complete the experiment and sessions will be conducted at a private neurology clinic in Dandenong and Goulburn Valley Health (GVH) in Shepparton. For healthy age-matched controls, sessions will be conducted at RMIT University or in a community setting in Rye, Victoria.
All experiments are conducted by the researchers from the School of Engineering, RMIT University or by a Movement disorders Nurse at GVH.
Intervention code [1] 325365 0
Early Detection / Screening
Intervention code [2] 325366 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy age-matched controls will complete the same experiments using the same equipment as above.
Control group
Active

Outcomes
Primary outcome [1] 333755 0
Analysis of the dynamics of sketching (drawing/tracing) using 2 parameters of measurement in combination - speed and pen pressure from the electronic drawing files of each participant.
Timepoint [1] 333755 0
Assessed after a single session of the hand sketching tasks
Primary outcome [2] 333963 0
Analysis of the dynamics of writing text using 2 parameters of measurement in combination - speed and pen pressure from electronic handwriting files.
Timepoint [2] 333963 0
Assessed after a single session of the hand writing tasks
Secondary outcome [1] 418190 0
Nil
Timepoint [1] 418190 0
Nil

Eligibility
Key inclusion criteria
1.People diagnosed with Parkinson's disease, as evidenced by Unified Parkinson's disease Rating Scale (UPDRS) scores consistent with minimal to moderate disease
2.Healthy age-matched controls
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For Parkinson''s disease participants - diagnosed with other neurodegenerative diseases or stroke; cognitive impairment as evidenced by Montreal Cognitive Assessment (MoCA) score less than 26/30

For healthy controls - diagnosis of any neurodegenerative disease or stroke

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size is calculated using a moderate to large effect size of 0.6 based on a previous study reported reported by some of our team (1.).
Statistical methods used for evaluation will be based on group differences (Independent-samples-t test / MANOVA or non parametric equivalent as required).

1.Zham, P., Kumar, D., Viswanthan, R. et al. Effect of levodopa on handwriting tasks of different complexity in Parkinson’s disease: a kinematic study. J Neurol 266, 1376–1382 (2019)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/11/2023
Actual
Date of last participant enrolment
Anticipated
20/11/2026
Actual
Date of last data collection
Anticipated
20/11/2026
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25735 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment postcode(s) [1] 41558 0
3630 - Shepparton
Recruitment postcode(s) [2] 41559 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 313131 0
University
Name [1] 313131 0
RMIT University
Country [1] 313131 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
GPO Box 2476, Melbourne VIC 3001 Australia
Country
Australia
Secondary sponsor category [1] 314833 0
None
Name [1] 314833 0
Nil
Address [1] 314833 0
Nil
Country [1] 314833 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312376 0
RMIT HREC
Ethics committee address [1] 312376 0
Ethics committee country [1] 312376 0
Australia
Date submitted for ethics approval [1] 312376 0
11/10/2023
Approval date [1] 312376 0
Ethics approval number [1] 312376 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124438 0
Prof Dinesh Kumar
Address 124438 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124438 0
Australia
Phone 124438 0
+61 399251954
Fax 124438 0
Email 124438 0
[email protected]
Contact person for public queries
Name 124439 0
Dinesh Kumar
Address 124439 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124439 0
Australia
Phone 124439 0
+61 399251954
Fax 124439 0
Email 124439 0
[email protected]
Contact person for scientific queries
Name 124440 0
Dinesh Kumar
Address 124440 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124440 0
Australia
Phone 124440 0
+61 399251954
Fax 124440 0
Email 124440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Saved data will not be identifiable except for participant grouping (healthy or Parkinson's disease)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18263Informed consent form    Directly from researchers conducting the study
18264Ethical approval    Directly from researchers conducting the study
18265Study protocol    Directly from researchers conducting the study



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.