Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000291886
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
16/03/2021
Date last updated
16/03/2021
Date data sharing statement initially provided
16/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial of a vestibular-stimulation, isometric exercise machine to manage symptoms of Parkinsonism: Imaging Substudy
Scientific title
A pilot randomised controlled trial of a vestibular-stimulation, isometric exercise machine to manage symptoms of Parkinsonism: Imaging Substudy
Secondary ID [1] 303419 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12621000139875 is the main trial of which the current application is a sub-study.
Participants enrolled in ACTRN12621000139875 will be offered the option to participate in this substudy, which involves an extra testing session before after the intervention period, in which they will have MRI scans.

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 320710 0
Atypical Parkinsonism 320711 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318555 318555 0 0
Other physical medicine / rehabilitation
Neurological 318556 318556 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACTRN12621000139875 describes a 12 week intervention using a physical exercise assistance device for patients with Parkinson's disease. The primary outcome measure was part 3 of the UPDRS ratings scale. The current application will include new patients enrolling in that trial and add MRI scanning as an additional outcome measure. After approval of this registration, all patients recruited in the main trial will be offered the option to undergo MRI scanning, which will involve T1, T2, diffusion and functional MRI scans at baseline and follow up, in addition to the other outcome measurements for the main trial described in step 4.
Imaging sessions will take place the week prior to the intervention commencement and 13 weeks after intervention commencement. They will last 30 minutes. The will be conducted by a radiologist at Alfred Hospital.
Intervention code [1] 319724 0
Treatment: Devices
Intervention code [2] 319725 0
Rehabilitation
Comparator / control treatment
Control subjects will follow the same MRI scanning protocol as treatment subjects.
Control group
Active

Outcomes
Primary outcome [1] 326513 0
MRI Imaging: T1-weighted: For structural analysis
Timepoint [1] 326513 0
baseline - week prior to commencement of intervention
follow up - 12 weeks after intervention commencement
Secondary outcome [1] 391741 0
MRI Imaging: T2-weighted: For quantification of perivascular spaces,
Timepoint [1] 391741 0
baseline - week prior to commencement of intervention
follow up - 12 weeks after intervention commencement
Secondary outcome [2] 391742 0
MRI Imaging: Diffusion weighted: For analysis of white matter integrity
Timepoint [2] 391742 0
baseline - week prior to commencement of intervention
follow up - 12 weeks after intervention commencement
Secondary outcome [3] 391743 0
MRI Imaging: Multi-echo T2* weighted imaging for quantitative susceptibility mapping: measurement of iron deposition and microbleeds
Timepoint [3] 391743 0
baseline - week prior to commencement of intervention
follow up - 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
1. Diagnosis of Parkinson’s Disease or Atypical Parkinsonism
2. Stage 2, 3 or 4 on the Hoehn and Yahr scale
3. Ability to speak English
4. Willingness and ability to provide written informed consent
5. Willingness and ability to attend twice weekly intervention sessions for 12 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

1. Significant dyskinesia
2. Significant motor fluctuations
3. Myasthenia Gravis, Charcot-Marie Tooth disease, Post-Polio Sundrome, Guillain–Barré syndrome, Fibromyalgia, herniated disk, osteoarthritis of the spine.
4. Diagnosis of dementia
5. Cognitive impairment that prevents patient from provided informed consent in the opinion of the recruiting study doctor.
6. Unable to undergo physical testing or ocular motor testing
7. Unstable or life-threatening disease or illness that could lead to difficulty complying with the protocol
8. Medical condition that contraindicates physical activity
9. Severe visual or auditory impairment
10. History of chronic alcohol abuse within the past 5 years
11. Unable to attend the follow-up assessments
12. Diagnosis of neurological disorder affecting balance
13. Diagnosis of muscular disorder affecting balance
14. Unable to undergo MRI scans

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
First stratified into Parkinson's and Atypical Parkinsonism.
The randomised to one of two groups using the method of randomly permuted blocks of size 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed effects ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/03/2021
Actual
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
6/09/2021
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18691 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 33129 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 307836 0
Government body
Name [1] 307836 0
Department of Industry Innovation and Science
Country [1] 307836 0
Australia
Funding source category [2] 307838 0
Commercial sector/Industry
Name [2] 307838 0
Isodynamics Corporation Pty. Ltd.
Country [2] 307838 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 308543 0
None
Name [1] 308543 0
Address [1] 308543 0
Country [1] 308543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307837 0
The Alfred Ethics Committee
Ethics committee address [1] 307837 0
Ethics committee country [1] 307837 0
Australia
Date submitted for ethics approval [1] 307837 0
22/06/2020
Approval date [1] 307837 0
14/01/2021
Ethics approval number [1] 307837 0

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

Contacts
Principal investigator
Name 108682 0
Prof Terence O'Brien
Address 108682 0
Central Clinical School
The Alfred Centre
99 Commercial Road
Prahran
3004
VIC
Country 108682 0
Australia
Phone 108682 0
+61399030855
Fax 108682 0
Email 108682 0
te.obrien@alfred.org.au
Contact person for public queries
Name 108683 0
Ben Sinclair
Address 108683 0
Central Clinical School
The Alfred Centre
99 Commercial Road
Prahran
3004
VIC
Country 108683 0
Australia
Phone 108683 0
+61415314218
Fax 108683 0
Email 108683 0
ben.sinclair@monash.edu
Contact person for scientific queries
Name 108684 0
Benjamin Sincair
Address 108684 0
Central Clinical School
The Alfred Centre
99 Commercial Road
Prahran
3004
VIC
Country 108684 0
Australia
Phone 108684 0
+61415314218
Fax 108684 0
Email 108684 0
ben.sinclair@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Group allocation and outcome measures (anonymised)
When will data be available (start and end dates)?
From publication of trial, available for 5 years after publication
Available to whom?
University partners undertaking multi-site studies.
Available for what types of analyses?
Meta-analyses. Mega-analyses
How or where can data be obtained?
Communication with principle investigator Terry O'Brien or research coordinator Ben Sinclair.
te.obrien@alfred.org.au
ben.sinclair@monash.edu


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10556Study protocol  ben.sinclair@monash.edu
10557Statistical analysis plan  ben.sinclair@monash.edu
10558Informed consent form  ben.sinclair@monash.edu
10559Ethical approval  ben.sinclair@monash.edu



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.