None listed
Conditions
Brief summary
Up to 180 participants will be recruited within 1 week of stroke onset over a 3 year period. Demographic and stroke characteristics will be collected at the time of recruitment. Approximately one week after stroke basic clinical assessments will be carried out evaluating participants' walking and balance, hand and arm movement. Transcranial Magnetic Stimulation (TMS) evaluation of the motor pathways of the paretic upper limb will be performed within the first week of stroke as part of routine clinical care. Between 1 and 4 weeks post-stroke, participants who are engaged in walking rehabilitation as an inpatient will be observed during a single physiotherapy session. During this time frame, participants who are engaged in upper limb rehabilitation as an inpatient will be observed during a single therapy session to evaluate content of upper limb therapy. A subset of 25 participants and their whanau and up to 20 clinicians will be invited to take part in interviews. Purposive sampling of Maori and Pacific participants will be used. These semi-structured interviews are designed to understand perceived benefits and risks of having walking prediction information available and identify potential barriers and facilitators to implementing TWIST in routine clinical care. Follow up phone call assessments of walking capacity will take place at 4, 6, 9, and 16 weeks. At 12 and 26 weeks post-stroke, basic clinical assessments evaluating arm and hand use, walking, and level of independence will be carried out. Participants who are walking independently will be fitted with an activity monitor to wear for 72 hours to measure steps taken at home and in the community.
Interventions
This is a prospective, single-site, longitudinal, mixed methods study observing motor recovery after stroke. The purpose of the study is to progress three prediction tools designed by our team along the development, validation, and implementation pipeline. It will use a combination of clinical and imaging features to develop IMPRESS (Intelligent Multimodal imaging platform to PREdict Stroke motor outcomeS), a prediction tool for upper and lower limb motor outcomes after stroke. The study will al
This is a prospective, single-site, longitudinal, mixed methods study observing motor recovery after stroke. The purpose of the study is to progress three prediction tools designed by our team along the development, validation, and implementation pipeline. It will use a combination of clinical and imaging features to develop IMPRESS (Intelligent Multimodal imaging platform to PREdict Stroke motor outcomeS), a prediction tool for upper and lower limb motor outcomes after stroke. The study will also externally validate TWIST (Time to Walking Independently after STroke), a previously developed and internally validated prediction tool for walking recovery after stroke. The IMPRESS and TWIST tools are not being used in clinical practice, and the prediction information that they generate will not be shared with participants. The study will also further develop and improve the neurophysiology component of the PREP2 (Predict REcovery Potential) upper limb prediction tool, which has already been externally validated and implemented in clinical practice. Participants in this study will receive a PREP2 prediction for their upper limb motor outcome as part of their routine clinical care. Participants in the ORCAS study will be asked to complete the following assessments in addition to usual clinical care. The combination of assessments they are asked to complete will depend on which prediction tools are suitable for them, and which prediction tools they have consented to participating in. Potential participants will be told which prediction tools are suitable for them, and they can choose which suitable tools they want to participate in at the time of consent. Baseline upper limb clinical assessments will be made within the first week post-stroke for the IMPRESS and PREP2 tools. These are listed below and will be carried out by a trained researcher at Auckland City Hospital. The upper limb assessment is expected to take up to 1 hour. Fugl-Meyer Upper Extremity scale Action Research Arm Test Bimanual Coordination After Stroke Scale Grooved Pegboard Test Grip and pinch force Cutaneous sensation at the base of the thumb using monofilaments Baseline lower limb clinical assessments will be made within the first week post-stroke for the IMPRESS and TWIST tools. These are listed below and will be carried out by a trained researcher at Auckland City Hospital. The lower limb assessment is expected to take up to 30 minutes. Functional Ambulation Category Score Lower limb muscle strength with Medical Research Council grading Berg Balance Scale Baseline cognitive clinical assessments will be made within the first week post-stroke for the IMPRESS and TWIST tools. These are listed below and will be carried out by a trained researcher at Auckland City Hospital. The cognitive assessment is expected to take up to 45 minutes. Star Cancellation Test Broken Hearts Test Montreal Cognitive Assessment Baseline neurophysiology assessment will be carried within the first week post-stroke for the PREP2 tool. This involves recording surface electromyography from the extensor carpi radialis, flexor carpi radialis, first dorsal interosseous, and abductor digiti minimi muscles of the paretic forearm and hand. This assessment will be carried out by a trained researcher using Transcranial Magnetic Stimulation at Auckland City Hospital. The researcher will use single-pulse TMS to record motor evoked potentials in the four muscles listed above. This single session is expected to take up to 1 hour and will be carried out within the first week post-stroke. Follow-up assessments at 4, 6, 9 and 16 weeks post-stroke will be carried out for the IMPRESS and TWIST tools. A trained assessor will complete this assessment either in person at Auckland City Hospital or by telephone if they have left hospital. The assessments are listed below, and each follow-up session is expected to last up to 15 minutes. Functional Ambulation Category score Any falls since last assessment Use of walking aids such as stick or low walking frame Place of residence Follow-up assessments at 12 and 26 weeks post stroke will be carried out for the IMPRESS, TWIST and PREP2 tools, as noted for each measure below. A trained assessor will complete these assessments in person either at Auckland City Hospital or at the University of Auckland. The assessments are listed below, and each follow-up session is expected to last between 30 and 90 minutes, depending on the combination of assessments completed. Action Research Arm Test – IMPRESS and PREP2 Fugl-Meyer Upper Extremity score – IMPRESS and PREP2 Modified Rankin Scale – IMPRESS, TWIST, and PREP2 Functional Ambulation Category score – IMPRESS and TWIST 6 minute walk test and 10 metre walk test – TWIST Spatiotemporal gait characteristics measured with a GaitRite gait mat – TWIST Additionally, participants in the TWIST prediction tool will also be asked to wear an activity monitor on their wrist for 72 hours to measure the number of steps they take during this time period. Related ACTRN registrations for the tools are: TWIST ACTRN12620001366943 PREP ACTRN12619000225112
Sponsors
The University of Auckland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years old 2. Ischaemic stroke or intracerebral haemorrhage within the previous 7 days 3. New upper and/or lower limb motor symptoms: 3a. Participants with a shoulder abduction and finger extension score (SAFE) less than or equal to 8 at 3 days are eligible for upper limb assessments 3b. Participants with a FAC score < 4 and lower limb weakness assessed with the Medical Research Council (MRC) strength grade < 5 at 1 week post-stroke are eligible for lower limb assessments 4. Previous stroke is allowed provided the patient had no residual upper or lower limb weakness and was walking independently prior to the new stroke 5. Treatment with thrombolysis or endovascular thrombectomy is allowed
Exclusion criteria
Exclusion criteria for the whole study i. Subarachnoid haemorrhage or cerebellar stroke ii. Severe cognitive or communication impairment precluding informed consent, based on clinical team expertise iii. Expected life span less than 6 months based on the assessment of the patient’s clinical team iv. Residing out of region precluding in-person assessment Exclusion criteria for specific parts of the study i. Participants who have had an intracerebral haemorrhage will be excluded from the IMPRESS prediction tool dataset ii. Participants with pre-existing upper limb motor impairment determined by a SAFE score less than or equal to 8 will be excluded from upper limb assessments iii. Participants who were unable to walk independently determined by FAC score < 4, or required the use of a walking frame prior to stroke will be excluded from lower limb assessments iv. Participants who are unable to receive TMS will be excluded from the TMS assessment. These participants will be identified with a safety screening checklist checked by a neurologist.
Outcome results
None listed