Skip to content

TWIST3: Validation of the Time to Walking Independently after STroke Tool

TWIST3: Validation of the Time to Walking Independently after Stroke Tool. A single-site, prospective, assessor-blind, mixed methods, observational study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620001366943
Acronym
TWIST3
Enrollment
98
Registered
2020-12-18
Start date
2021-01-05
Completion date
2024-09-24
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. Assessments at 12 and 26 weeks post-stroke will take place in person if possible.

Interventions

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

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. Walking ability will be evaluated in person if possible at 12 and 26 weeks after stroke.

Sponsors

The University of Auckland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026