Clinical trial NCT02464085: Characterising Arm Recovery in People With Severe Stroke
Official title: Characterising Arm Recovery in People With Severe Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Upper limb
Neuroplastic change
Longitudinal
Function
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke survivors with subacute and severe upper limb disability will be evaluated longitudinally.

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.

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

Primary outcomes:
measure: 3T Magnetic Resonance Imaging (MRI)
timeFrame: up to 12-months
Secondary outcomes:
measure: Shoulder abduction and finger extension (SAFE)
timeFrame: 12-months
measure: Fugl-Meyer Assessment (arm and sensory)
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: Motor Assessment Scale items 6,7,8
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: REACH (Rating of Everyday Arm Use in the Community and Home)
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: Accelerometry
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: PASS (Postural Assessment Scale for Stroke patients)
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: 10-metre walk test
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: Dose of upper limb training
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: National Institute of Stroke Severity Scale
timeFrame: <4-weeks
measure: Oxfordshire Bamford Classification
timeFrame: <4-weeks
measure: Myelin water fraction imaging (WMI)
timeFrame: <4wks, 3-months, 6-months, 12-months
measure: Meaningful arm recovery questionnaire
timeFrame: <4wks, 3-months, 6-months, 12-months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lara A Boyd, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayward KS, Lohse KR, Bernhardt J, Lang CE, Boyd LA. Characterising Arm Recovery in People with Severe Stroke (CARPSS): protocol for a 12-month observational study of clinical, neuroimaging and neurophysiological biomarkers. BMJ Open. 2018 Nov 25;8(11):e026435. doi: 10.1136/bmjopen-2018-026435.