Characterising Arm Recovery in People With Severe Stroke

• Conditions: Stroke
• Interventions: Other: Longitudinal evaluation of recovery

• Registration Number: NCT02464085
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Study Start: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• neurological condition other than stroke e.g., Parkinson's disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Longitudinal evaluation of recovery	Longitudinal evaluation of recovery	Stroke survivors with subacute and severe upper limb disability

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada