CARPSS: Characterising Arm Recovery in People With Severe Stroke

Sponsor
University of British Columbia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02464085
Collaborator
(none)
50
1
53
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Study Details

Study Description

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'

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Characterising Arm Recovery in People With Severe Stroke
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Shoulder abduction and finger extension (SAFE) [12-months]

    Measurement of upper limb strength

  2. Fugl-Meyer Assessment (arm and sensory) [<4wks, 3-months, 6-months, 12-months]

    Measurement of upper limb impairment

  3. Motor Assessment Scale items 6,7,8 [<4wks, 3-months, 6-months, 12-months]

    Measurement of upper limb activity

  4. 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

  5. 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

  6. 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

  7. 10-metre walk test [<4wks, 3-months, 6-months, 12-months]

    Measurement of walking ability

  8. Montreal Cognitive Assessment (MoCA) [<4wks, 3-months, 6-months, 12-months]

    Measurement of cognitive impairment after stroke

  9. 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

  10. National Institute of Stroke Severity Scale [<4-weeks]

    Characterise stroke severity

  11. Oxfordshire Bamford Classification [<4-weeks]

    Characterise stroke type

  12. Myelin water fraction imaging (WMI) [<4wks, 3-months, 6-months, 12-months]

    Determine the myelin content within the brain

  13. Meaningful arm recovery questionnaire [<4wks, 3-months, 6-months, 12-months]

    Explore the stroke survivor's perception of meaningful recovery of their upper limb

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of British Columbia Vancouver British Columbia Canada V6T1Z3

Sponsors and Collaborators

  • University of British Columbia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02464085
Other Study ID Numbers:
  • H15-00083
First Posted:
Jun 8, 2015
Last Update Posted:
Jan 10, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by University of British Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2017