Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000225112
Ethics application status
Approved
Date submitted
13/02/2019
Date registered
18/02/2019
Date last updated
5/07/2022
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PREP2 VIP: Validating the PREP2 algorithm for predicting hand and arm function after stroke.
Scientific title
PREP2 VIP: A prospective, single site, assessor-blind, longitudinal, observational study to validate in clinical practice the PREP2 algorithm for predicting upper limb functional outcomes at the sub-acute stage of stroke
Secondary ID [1] 297382 0
None
Universal Trial Number (UTN)
None
Trial acronym
PREP2 VIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 311534 0
Condition category
Condition code
Neurological 310171 310171 0 0
Other neurological disorders
Stroke 310203 310203 0 0
Ischaemic
Stroke 310204 310204 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Predict Recovery Potential (PREP2) algorithm predicts hand and arm function outcomes. It can be used within a week of stroke, and makes predictions for 3 months after stroke. For patients with hand and arm weakness after stroke, the first assessment involves evaluating strength in shoulder abduction and finger extension, 3 days after stroke. For most patients, the results of this assessment, combined with their age, is enough information to make the prediction. For some patients, an additional test of a key motor pathway in the brain is needed. This test involves using transcranial magnetic stimulation (TMS) to see whether activating the stroke side of the brain can produce a response in the muscles of the affected hand and arm. This test is safe, painless, and non-invasive, and takes around 20 minutes. The results of this test, combined with a clinical score of stroke severity (the National Institutes of Health Stroke Scale) can be used to make a prediction for remaining patients, within 7 days after stroke. The PREP2 algorithm is part of routine clinical care at Auckland City Hospital, where this project will take place. Patients who have a PREP2 prediction will be invited to take part in the project, provided they also meet other inclusion criteria, detailed elsewhere.
Intervention code [1] 313638 0
Not applicable
Comparator / control treatment
Observational study with no control group.
For each participant, we will compare their predicted and actual outcome using the PREP2 algorithm categories, which are based on Action Research Arm Test score at 3 months post-stroke.
Control group
Active

Outcomes
Primary outcome [1] 319056 0
Action Research Arm Test score
Timepoint [1] 319056 0
90 days post-stroke
Secondary outcome [1] 366836 0
Upper Extremity Fugl-Meyer Scale score - motor component
Timepoint [1] 366836 0
90 days post-stroke
Secondary outcome [2] 366837 0
Upper limb motor function tested with the Box and Blocks Test
Timepoint [2] 366837 0
90 days post-stroke
Secondary outcome [3] 366838 0
Hand sensation assessed with Semmes-Weinstein monofilaments
Timepoint [3] 366838 0
90 days post-stroke
Secondary outcome [4] 366839 0
Patient report of affected upper limb edema using a Likert scale
Timepoint [4] 366839 0
90 days post-stroke
Secondary outcome [5] 366840 0
Patient report of affected upper limb pain using a Likert scale
Timepoint [5] 366840 0
90 days post-stroke
Secondary outcome [6] 366841 0
Patient report of quality of life using the PHQ-9
Timepoint [6] 366841 0
90 days post-stroke
Secondary outcome [7] 366842 0
Patient report of the experience of receiving a PREP2 prediction for their hand and arm, obtained using a semi-structured interview in a subset of 20 participants.
Timepoint [7] 366842 0
90 days post-stroke

Eligibility
Key inclusion criteria
A prediction for upper limb functional outcome has been made using the PREP2 (Predict Recovery Potential 2) algorithm by the clinical team responsible for the patient.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cerebellar stroke
Life expectancy less than 12 months
Severe cognitive or communication impairment precluding informed consent
Residing out of area precluding follow-up

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Up to 120 patients will be recruited, and this sample size is based on our previous work showing that at least 100 patients are required to obtain a representative sample of PREP2 predictions.
The accuracy of PREP2 predictions will be evaluated by comparing the predicted and actual outcome for each participant. The PREP2 algorithm will be considered validated in clinical practice if the predicted outcome is correct for at least 70% of participants, because previous research has found the algorithm to be correct for 75% (95% CI 70 - 90%) of patients.
A subset of up to 20 participants will be asked to complete short semi-structured interviews about their experience of being given a PREP2 prediction, for qualitative thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2019
Actual
6/05/2019
Date of last participant enrolment
Anticipated
1/10/2021
Actual
28/07/2021
Date of last data collection
Anticipated
1/04/2022
Actual
19/01/2022
Sample size
Target
120
Accrual to date
Final
106
Recruitment outside Australia
Country [1] 21278 0
New Zealand
State/province [1] 21278 0
Auckland

Funding & Sponsors
Funding source category [1] 301952 0
Charities/Societies/Foundations
Name [1] 301952 0
Neurological Foundation of New Zealand
Country [1] 301952 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 301709 0
None
Name [1] 301709 0
Address [1] 301709 0
Country [1] 301709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302634 0
Health and Disability Ethics Committee
Ethics committee address [1] 302634 0
Ethics committee country [1] 302634 0
New Zealand
Date submitted for ethics approval [1] 302634 0
18/02/2019
Approval date [1] 302634 0
16/04/2019
Ethics approval number [1] 302634 0
19NTB27

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

Contacts
Principal investigator
Name 51002 0
Prof Cathy Stinear
Address 51002 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 51002 0
New Zealand
Phone 51002 0
+6499233779
Fax 51002 0
Email 51002 0
[email protected]
Contact person for public queries
Name 51003 0
Cathy Stinear
Address 51003 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 51003 0
New Zealand
Phone 51003 0
+6499233779
Fax 51003 0
Email 51003 0
[email protected]
Contact person for scientific queries
Name 51004 0
Cathy Stinear
Address 51004 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 51004 0
New Zealand
Phone 51004 0
+6499233779
Fax 51004 0
Email 51004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data requested.
When will data be available (start and end dates)?
From the end of data collection (01.04.2022) for five years (01.04.2027).
Available to whom?
Anonymised data will be made available upon reasonable request by researchers, at the discretion of the principal investigator.
Available for what types of analyses?
Any.
How or where can data be obtained?
Anonymised data will be electronically transferred to the requestor.


What supporting documents are/will be available?

No Supporting Document Provided



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.