Characterising Arm Recovery in People With Severe Stroke

Stroke Clinical Trial

— CARPSS  

Official title:

Characterising Arm Recovery in People With Severe Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02464085
• Other study ID #: H15-00083
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2015
• Last updated: January 9, 2017
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2017
• Source: University of British Columbia
• Contact: Kathryn S Hayward, PT PhD
• Phone: 6048273369
• Email: kathryn.hayward[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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'

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Longitudinal evaluation of recovery
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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Shoulder abduction and finger extension (SAFE)	Measurement of upper limb strength	12-months	No
Secondary	Fugl-Meyer Assessment (arm and sensory)	Measurement of upper limb impairment	<4wks, 3-months, 6-months, 12-months	No
Secondary	Motor Assessment Scale items 6,7,8	Measurement of upper limb activity	<4wks, 3-months, 6-months, 12-months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	10-metre walk test	Measurement of walking ability	<4wks, 3-months, 6-months, 12-months	No
Secondary	Montreal Cognitive Assessment (MoCA)	Measurement of cognitive impairment after stroke	<4wks, 3-months, 6-months, 12-months	No
Secondary	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	No
Secondary	National Institute of Stroke Severity Scale	Characterise stroke severity	<4-weeks	No
Secondary	Oxfordshire Bamford Classification	Characterise stroke type	<4-weeks	No
Secondary	Myelin water fraction imaging (WMI)	Determine the myelin content within the brain	<4wks, 3-months, 6-months, 12-months	No
Secondary	Meaningful arm recovery questionnaire	Explore the stroke survivor's perception of meaningful recovery of their upper limb	<4wks, 3-months, 6-months, 12-months	No