Please note the ANZCTR will be unattended from Friday 24 December 2021 for the holidays. The Registry will re-open on Monday 17 January 2022. Submissions and updates will not be processed during that time.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

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 registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Study type
Patient registry
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

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.

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
Both males and females
Can healthy volunteers participate?
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
Natural history
Convenience sample
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 9267 0
New Zealand
State/province [1] 9267 0

Funding & Sponsors
Funding source category [1] 297701 0
Name [1] 297701 0
Auckland Academic Health Alliance Collaboration Fund, the Auckland District Health Board and the University of Auckland
Address [1] 297701 0
C/- University of Auckland
Faculty of Medical and Health Sciences
Private Bag 92019 AMC
Auckland 1142

Country [1] 297701 0
New Zealand
Funding source category [2] 301946 0
Name [2] 301946 0
Neurological Foundation of New Zealand
Address [2] 301946 0
66 Grafton Rd
Auckland 1010
New Zealand
Country [2] 301946 0
New Zealand
Primary sponsor type
The University of Auckland
Private Bag 92019 AMC
Auckland 1142
New Zealand
Secondary sponsor category [1] 296733 0
Name [1] 296733 0
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
Auckland 1023
Country [1] 279760 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 298772 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 298772 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298772 0
New Zealand
Date submitted for ethics approval [1] 298772 0
Approval date [1] 298772 0
Ethics approval number [1] 298772 0

Brief summary
Stroke is a leading cause of long-term adult disability. The most common rehabilitation goal after stroke is to be able to walk again. However, of those initially unable to walk, only 60-70% recover the ability to walk independently by 6 months. Predicting the recovery of walking after stroke may assist clinicians, patients and their families to set realistic and attainable goals during rehabilitation and to make more informed decisions around discharge planning. Decisions around whether a patient is able to return to their own home after the stroke or whether they need to move into a residential care facility are often based on the ability to walk independently.

Our research group has recently developed the TWIST (Time to Walk Independently after Stroke Trial) algorithm that enables a clinician, at 1 week after stroke, to predict not only whether an individual patient will walk independently, but when they will achieve this. The algorithm correctly predicted time to walk independently for 92% of patients. The purpose of this observational study is to evaluate and validate the TWIST algorithm in a larger patient sample.
Trial website
Trial related presentations / publications
Public notes

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
Fax 78186 0
Email 78186 0
Contact person for public queries
Name 78187 0
Dr 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
Fax 78187 0
Email 78187 0
Contact person for scientific queries
Name 78188 0
Dr 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
Fax 78188 0
Email 78188 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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?
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 other documents available
Summary results
No Results