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Trial registered on ANZCTR


Registration number
ACTRN12617001434381
Ethics application status
Approved
Date submitted
6/10/2017
Date registered
10/10/2017
Date last updated
11/02/2021
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
TWIST: Time to Walking Independently after STroke
Scientific title
TWIST: A prospective, single-site, assessor-blind observational study to validate the Time to Walking Independently after STroke (TWIST) algorithm
Secondary ID [1] 293080 0
Nil
Universal Trial Number (UTN)
U1111-1203-2929
Trial acronym
TWIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 305009 0
Condition category
Condition code
Stroke 304330 304330 0 0
Ischaemic
Stroke 304351 304351 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will observe recovery of walking ability after stroke. Participants' walking ability will be classified using the Functional Ambulation Category at 1, 2, 4, 6, 9, 12, 16, 20 and 26 weeks post-stroke. The TWIST algorithm combines clinical assessments of trunk control and lower limb muscle strength in order to predict when a patient will recover independent walking. The algorithm was previously developed in a sample of 40 patients. This study will validate the algorithm by seeing whether it correctly predicts the recovery of independent walking in an independent and larger sample of patients.
Intervention code [1] 299321 0
Diagnosis / Prognosis
Comparator / control treatment
The accuracy of TWIST algorithm predictions will be compared to the accuracy of therapists' predictions.
Control group
Active

Outcomes
Primary outcome [1] 303593 0
Week post-stroke at which the patient is able to walk independently, defined as a Functional Ambulation Category score of either 4 or 5.
Timepoint [1] 303593 0
Walking ability will be assessed using the Functional Ambulation Category scores, at 1, 2, 4, 6, 9, 12, 16, 20 and 26 weeks post-stroke.
Secondary outcome [1] 339529 0
Walking ability at 26 weeks post-stroke, measured with the Functional Ambulation Category.
Timepoint [1] 339529 0
26 weeks post-stroke.
Secondary outcome [2] 339530 0
Discharge destination at the conclusion of inpatient rehabilitation
Timepoint [2] 339530 0
Discharge from inpatient rehabilitation
Secondary outcome [3] 339603 0
The accuracy of TWIST algorithm predictions will be compared to the accuracy of therapists' predictions.
Timepoint [3] 339603 0
The week post-stroke by which patients recover independent walking.

Eligibility
Key inclusion criteria
Ischaemic stroke or intracerebral haemorrhage within the previous 72 hours
New lower limb motor symptoms
At least 18 years old
Previous stroke is allowed provided the patient was walking independently prior to the new stroke
Cognitive or communication impairment is allowed as assent to participation can be obtained from a family member
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subarachnoid haemorrhage
Unable to follow a one-step command, precluding lower limb strength testing
Contraindications to non-invasive transcranial magnetic stimulation
Pre-stroke Functional Ambulation Category score less than 4, meaning the patient was not walking independently
Other neurological or orthopaedic conditions affecting lower limb function or walking
Life expectancy less than 12 months

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The planned sample size is 140 patients. Allowing for attrition, the sample size available for analysis is estimated to be 100 patients. With this sample size, we estimate that there will be at least 20 patients in each outcome group (based on the week that independent walking was regained after stroke). This is sufficient for analysis with a Classification and Regression Tree (CaRT). First, a hypothesis-free cluster analysis will be used to categorise patients based on their primary outcome (week they achieved independent walking after stroke). All baseline clinical and demographic variables, lower limb motor-evoked potential (MEP) status, therapy dose, and falls, will be entered into the CaRT analysis, to determine which factors best predict the primary outcome categories. The results of the CaRT analysis will be used to validate the TWIST algorithm, which is a clinical decision tree for predicting the week at which a patient will recover independent walking after stroke. Baseline clinical and demographic variables, lower limb MEP status, therapy dose, and falls, will be also entered into separate analyses, to determine which factors best predict the secondary outcomes of FAC value at six months post-stroke and discharge destination.

Therapists will be asked 1 week post-stroke to predict whether each participant will recover independent walking by 6 months post-stroke, and if so, at what time point. The accuracy of therapists' predictions will be compared to the TWIST algorithm's predictions to determine whether the algorithm performs as well as, or better than, therapists' clinical judgement. Secondary analyses will explore whether the accuracy of therapist predictions varies depending on the therapists' confidence and experience levels, and depending on patient factors such as age and stroke severity.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/02/2018
Actual
21/02/2018
Date of last participant enrolment
Anticipated
1/07/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
140
Accrual to date
115
Final
Recruitment outside Australia
Country [1] 9267 0
New Zealand
State/province [1] 9267 0
Auckland

Funding & Sponsors
Funding source category [1] 297701 0
University
Name [1] 297701 0
Auckland Academic Health Alliance Collaboration Fund, the Auckland District Health Board and the University of Auckland
Country [1] 297701 0
New Zealand
Funding source category [2] 301946 0
Charities/Societies/Foundations
Name [2] 301946 0
Neurological Foundation of New Zealand
Country [2] 301946 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019 AMC
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 296733 0
None
Name [1] 296733 0
None
Address [1] 296733 0
Country [1] 296733 0
Other collaborator category [1] 279760 0
Government body
Name [1] 279760 0
Auckland District Health Board
Address [1] 279760 0
2 Park Rd
Grafton
Auckland 1023
Country [1] 279760 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298772 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 298772 0
Ethics committee country [1] 298772 0
New Zealand
Date submitted for ethics approval [1] 298772 0
01/11/2017
Approval date [1] 298772 0
14/02/2018
Ethics approval number [1] 298772 0

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

Contacts
Principal investigator
Name 78186 0
Prof Cathy Stinear
Address 78186 0
Department of Medicine
University of Auckland
Private Bag 92019 AMC
Auckland 1142
Country 78186 0
New Zealand
Phone 78186 0
+6499233779
Fax 78186 0
Email 78186 0
c.stinear@auckland.ac.nz
Contact person for public queries
Name 78187 0
Marie-Claire Smith
Address 78187 0
Department of Medicine
University of Auckland
Private Bag 92019 AMC
Auckland 1142
Country 78187 0
New Zealand
Phone 78187 0
+6499236919
Fax 78187 0
Email 78187 0
m-c.smith@auckland.ac.nz
Contact person for scientific queries
Name 78188 0
Marie-Claire Smith
Address 78188 0
Department of Medicine
University of Auckland
Private Bag 92019 AMC
Auckland 1142
Country 78188 0
New Zealand
Phone 78188 0
+6499236919
Fax 78188 0
Email 78188 0
m-c.smith@auckland.ac.nz

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 requested data.
When will data be available (start and end dates)?
From 01/01/2021 until 31/12/2026
Available to whom?
Researchers who request access.
Available for what types of analyses?
Any.
How or where can data be obtained?
The research team will evaluate all reasonable requests for data. Anonymised electronic data will be made available in response to approved requests.


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.