Characterising Arm Recovery in People With Severe Stroke

NCT ID: NCT02464085

Last Updated: 2017-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Longitudinal evaluation of recovery

Stroke survivors with subacute and severe upper limb disability

Longitudinal evaluation of recovery

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lara A Boyd, PT PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Kathryn S Hayward, PT PhD

Role: CONTACT

6048273369

Lara A Boyd, PT PhD

Role: CONTACT

6048273369

Facility Contacts

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Kathryn S Hayward, PT PhD

Role: primary

6048273369

Lara A Boyd, PT PhD

Role: backup

6048273369

References

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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.

Reference Type DERIVED
PMID: 30478130 (View on PubMed)

Other Identifiers

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H15-00083

Identifier Type: -

Identifier Source: org_study_id

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