Characterising Arm Recovery in People With Severe Stroke (CARPSS)

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'

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Longitudinal evaluation of recovery

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T1Z3
      • Recruiting
      • University of British Columbia
      • Contact: Kathryn S Hayward, PT PhD; Phone Number: 6048273369; Email: kathryn.hayward@ubc.ca
      • Contact: Lara A Boyd, PT PhD; Phone Number: 6048273369; Email: lara.boyd@ubc.ca
      • Sub-Investigator: Julie Bernhardt, PT PhD
      • Principal Investigator: Lara A Boyd, PT PhD
      • Sub-Investigator: Kathryn S Hayward, PT PhD
      • Sub-Investigator: Catherine E Lang, PT PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Stroke survivors with subacute and severe upper limb disability will be evaluated longitudinally.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Longitudinal evaluation of recovery; Stroke survivors with subacute and severe upper limb disability	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.

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Lara A Boyd, PT PhD, University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; Upper limb; Function; Longitudinal; Neuroplastic change
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H15-00083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED