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Trial registered on ANZCTR


Registration number
ACTRN12620001366943
Ethics application status
Approved
Date submitted
6/10/2020
Date registered
18/12/2020
Date last updated
18/12/2020
Date data sharing statement initially provided
18/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
TWIST3: Validation of the Time to Walking Independently after STroke Tool
Scientific title
TWIST3: Validation of the Time to Walking Independently after Stroke Tool. A single-site, prospective, assessor-blind, mixed methods, observational study
Secondary ID [1] 302471 0
None
Universal Trial Number (UTN)
Trial acronym
TWIST3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 319302 0
Condition category
Condition code
Stroke 317271 317271 0 0
Ischaemic
Stroke 317272 317272 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 317273 317273 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The TWIST tool involves combining information collected from participants' medical records and clinical assessments carried out in person within 1 week of stroke. The clinical assessments involve evaluating: lower limb muscle strength with standard Medical Research Council grading of muscle power; trunk control with the Trunk Control Test; balance with the Berg Balance Test; visuospatial inattention with the Star Cancellation Test; lower limb sensation with monofilaments. These assessments will take up to 40 minutes to complete, and will be completed by a trained research therapist once at one week post-stroke.

Recovery of walking ability will be observed, beginning within 1 week after stroke and ending at 6 months after stroke. Walking ability will be evaluated at 1, 4, 6, 9, 12, and 26 weeks after stroke. Walking ability will be graded using the Functional Ambulation Category (FAC) with independent walking defined as an FAC score of 4 or 5 (out of a maximum score of 5). Walking ability will be evaluated in person while participants are inpatients, and by telephone once participants have been discharged from hospital.
Intervention code [1] 318764 0
Diagnosis / Prognosis
Comparator / control treatment
No control group as this is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325328 0
The primary outcome is the week post-stroke at which the participant is able to walk independently, defined as a Functional Ambulation Category (FAC) score of 4 or 5 (out of a maximum score of 5).
Timepoint [1] 325328 0
The primary outcome will be evaluated at 1, 4, 6, 9, 12, and 26 weeks post-stroke, and will be considered to have been achieved at the earliest time point when the participant is able to walk independently, as defined above.
Secondary outcome [1] 387515 0
Use of walking aids at the primary endpoint, defined as the use of an ankle-foot orthosis, walking stick, quad cane, low walking frame, or gutter frame. This is defined as yes or no, based on patient report of any aids used for their usual, daily walking activities. The use of walking aids will be evaluated in person if the participant is an inpatient, or by telephone if the participant has been discharged from hospital.
Timepoint [1] 387515 0
The time point at which the participant achieves the primary endpoint is the time point at which this secondary outcome will be evaluated.
Secondary outcome [2] 387516 0
Discharge destination, defined as previous residence or new residence. Residence is further categorised as private home alone, private home not alone, aged residential care facility, or private hospital. This information will be collected by telephone call with participants.
Timepoint [2] 387516 0
This outcome is evaluated at the time of discharge from inpatient care, and measured in weeks post-stroke.

Eligibility
Key inclusion criteria
i. At least 18 years old
ii. Ischaemic stroke or intracerebral haemorrhage within the previous 7 days
iii. New lower limb motor symptoms
iv. Currently unable to walk independently (Functional Ambulation Category score < 4)
v. Previous stroke is allowed provided the patient was walking independently prior to the new stroke
vi. Treatment with thrombolysis or endovascular thrombectomy is allowed
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Subarachnoid haemorrhage or cerebellar stroke
ii. Unable to walk independently prior to stroke (FAC score < 4) or required the use of a walking frame
iii. Severe cognitive or communication impairment precluding informed consent, based on the patient’s clinical team's assessment
iv. Expected life span less than 6 months based on the assessment of the patient’s clinical team's assessment

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
a. The primary outcome is the time at which independent walking, defined as FAC score of at least 4, is achieved, measured as weeks post-stroke
b. Binary logistic regression modelling will be used to evaluate how accurately the TWIST score predicts independent walking at each time point post-stroke (4, 6, 9, 12 and 26 weeks post-stroke).
c. Calibration plots will be used to visually inspect model performance, and the Hosmer-Lemeshow test will be used with p < 0.05 considered evidence of miscalibration of the model.
d. The TWIST score will be considered an externally validated predictor for each time point post-stroke where predictions are accurate for at least 85% of participants.
e. The TWIST prediction tool as a whole will be considered externally validated if it makes accurate predictions for at least 85% of participants at a minimum of 3 time points post-stroke (any combination of 4, 6, 9, 12 and 26 weeks).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23045 0
New Zealand
State/province [1] 23045 0

Funding & Sponsors
Funding source category [1] 306897 0
Charities/Societies/Foundations
Name [1] 306897 0
Neurological Foundation of New Zealand
Address [1] 306897 0
66 Grafton Road
Grafton
Auckland 1010
Country [1] 306897 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 307456 0
None
Name [1] 307456 0
Address [1] 307456 0
Country [1] 307456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307051 0
Health and Disability Ethics Committee
Ethics committee address [1] 307051 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 307051 0
New Zealand
Date submitted for ethics approval [1] 307051 0
01/10/2020
Approval date [1] 307051 0
10/12/2020
Ethics approval number [1] 307051 0
20/CEN/223

Summary
Brief summary
Up to 125 participants will be recruited within 1 week of stroke onset at Auckland City Hospital. Demographic and stroke characteristics, and previous walking ability (Functional Ambulation Category (FAC)) will be collected at the time of recruitment. One week clinical assessments will include current walking ability (FAC), Berg Balance Test for postural control and balance, Medical Research Council (MRC) strength grades for the lower limb, Trunk Control Test for trunk control and bed mobility, Star Cancellation Test for visuospatial neglect, and lower limb sensation measured with monofilaments. One week assessments will inform the TWIST prediction.

The TWIST prediction tool will be used to make a prediction for recovery of independent walking, defined as an FAC score of 4 or 5. Researchers will obtain TWIST predictions for all participants, but these will not be shared with patients, whanau or clinicians. The primary outcome is the week post-stroke at which an FAC score of at least 4 is achieved. The FAC score will be determined at 4, 6, 9, 12, and 26 weeks post-stroke. The FAC score will be obtained from the clinical notes while participants are inpatients, and by telephone call with the participant or their nominated family member after discharge from hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105854 0
Prof Cathy Stinear
Address 105854 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 105854 0
New Zealand
Phone 105854 0
+6499233779
Fax 105854 0
Email 105854 0
c.stinear@auckland.ac.nz
Contact person for public queries
Name 105855 0
Prof Cathy Stinear
Address 105855 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 105855 0
New Zealand
Phone 105855 0
+6499233779
Fax 105855 0
Email 105855 0
c.stinear@auckland.ac.nz
Contact person for scientific queries
Name 105856 0
Prof Cathy Stinear
Address 105856 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 105856 0
New Zealand
Phone 105856 0
+6499233779
Fax 105856 0
Email 105856 0
c.stinear@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?
Anonymised individual participant data underlying published results.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years after publication of the main study results.
Available to whom?
Case by case basis at the discretion of the principal investigator.
Available for what types of analyses?
IPD meta-analyses.
How or where can data be obtained?
Data can be requested by contacting the principal investigator by email: c.stinear@auckland.ac.nz
What supporting documents are/will be available?
No other documents available
Summary results
No Results