Characterising Arm Recovery in People With Severe Stroke

Study Overview
=================
Brief Summary
-----------------
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The investigators will determine 'who recovers', 'who does not recover', and 'why'

Detailed Description
-----------------
The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The prevalence and severity of stroke related arm disability is increasing and the prospect of optimal recovery is poor. Studies have demonstrated that stroke survivors with severe disability lack early indicators (<7-days to <1-month post-stroke) of a good prognosis, such as active movement at the shoulder and wrist and integrity of the corticospinal tract. This has propagated the clinical belief that this cohort are unlikely to functionally benefit from rehabilitation efforts. However, it is possible that indicators of potential for recovery - either neuroanatomical or clinical - may present in individuals with severe stroke later, that is beyond the early time-period. Indeed, there is increasing evidence of the potential for ongoing improvements in motor performance in response to intensive interventions that are undertaken 6-months or more post-stroke. This therefore, implies that there is some degree of untapped recovery potential. However, as very few studies have longitudinally explored the potential indicators of recovery in a severe cohort, the dynamic capacity of the severely damaged remains unknown. Thus, there is a need to determine 'who recovers', 'who does not recover', and 'why' to be able to promote optimal arm recovery in people with severe impairment after stroke. We will assess stroke survivors <4-weeks, 3-months, 6-months and 12-months post stroke using a range of neuroimaging and clinical outcome measures. The findings from this study will build the foundations for more personalized health care options for people with severe arm impairment post stroke.

Official Title
-----------------
Characterising Arm Recovery in People With Severe Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Longitudinal evaluation of recovery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults aged 18 to 90 years; sustained their first stroke; demonstrate subacute (<1 month) and severe upper limb motor deficits (defined by a SAFE [shoulder abduction and finger extension] score of <5 out of 10 points); and can follow single stage commands Exclusion Criteria: neurological condition other than stroke e.g., Parkinson's disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Longitudinal evaluation of recovery<br>Stroke survivors with subacute and severe upper limb disability | Other: Longitudinal evaluation of recovery<br>* Stroke survivors will be assessed at four time frames post stroke to evaluate neuroplastic and clinical changes in arm recovery over the first 12-months post stroke.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3T Magnetic Resonance Imaging (MRI) | Determine the structural and functional connectivity of the brain using diffusion weighted imaging, resting state-functional magnetic resonance imaging and myelin water fraction imaging. | up to 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder abduction and finger extension (SAFE) | Measurement of upper limb strength | 12-months | 
| Fugl-Meyer Assessment (arm and sensory) | Measurement of upper limb impairment | <4wks, 3-months, 6-months, 12-months | 
| Motor Assessment Scale items 6,7,8 | Measurement of upper limb activity | <4wks, 3-months, 6-months, 12-months | 
| REACH (Rating of Everyday Arm Use in the Community and Home) | Self-report measure of everyday arm use | <4wks, 3-months, 6-months, 12-months | 
| Accelerometry | Measurement of real world arm use (activity count) over a 7-day period at each time frame | <4wks, 3-months, 6-months, 12-months | 
| PASS (Postural Assessment Scale for Stroke patients) | Measurement of balance (static and dynamic) and lower limb functional tasks | <4wks, 3-months, 6-months, 12-months | 
| 10-metre walk test | Measurement of walking ability | <4wks, 3-months, 6-months, 12-months | 
| Montreal Cognitive Assessment (MoCA) | Measurement of cognitive impairment after stroke | <4wks, 3-months, 6-months, 12-months | 
| Dose of upper limb training | Dose in minutes of passive, active, functional or sensory upper limb tasks performed over a 7-day period at each time frame | <4wks, 3-months, 6-months, 12-months | 
| National Institute of Stroke Severity Scale | Characterise stroke severity | <4-weeks | 
| Oxfordshire Bamford Classification | Characterise stroke type | <4-weeks | 
| Myelin water fraction imaging (WMI) | Determine the myelin content within the brain | <4wks, 3-months, 6-months, 12-months | 
| Meaningful arm recovery questionnaire | Explore the stroke survivor's perception of meaningful recovery of their upper limb | <4wks, 3-months, 6-months, 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Upper limb, Neuroplastic change, Longitudinal, Function