NCT03287739

Brief Summary

Upper limb recovery after stroke is highly predictable early after stroke. Nijland et al. showed that based on two simple clinical bedside tests - 'Shoulder Abduction' and 'Finger Extension' (the so called 'SAFE model' \[Stinear et al., 2012\]) - measured within the first 72 hours after stroke, \~87% of the patients could be correctly classified as either regaining or not regaining some dexterity (recoverers or nonrecoverers, respectively) (Nijland et al., 2010). This kind of information regarding the patients' functional prognosis allows proper discharge planning, setting realistic rehabilitation goals, and adequate patient information. However, the length of hospital stay after stroke has been decreasing. Therefore, knowledge is needed regarding the ability to make an accurate first prediction within the first 24 hours after stroke onset while using simple clinical bedside assessments. This would facilitate an earlier triage and with that, an accelerated and smooth transition of patients within the stroke care continuum. In addition, a first prediction within 24 hours poststroke has the potential to decrease health care expenses, as length of hospital stay after an acute stroke is \~30% of the total costs (i.e., direct and indirect costs) associated with stroke (Roger et al., 2012; Fattore et al., 2012). The primary objective of aRISE is to determine the ability of the behavioral biometric impairments 'Shoulder Abduction' and 'Finger Extension' measured \<24 hours poststroke to predict outcome of upper limb capacity 3 months after stroke. The secondary aim is to investigate the the added value of other simple clinical bedside tests for predicting outcome of upper limb capacity 3 months poststroke. aRISE is a prospective longitudinal observational cohort study of 40 first-ever ischemic stroke patients, who will be assessed \<24 hours, 7 days and 3 months after stroke onset.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

September 12, 2017

Last Update Submit

February 6, 2020

Conditions

Stroke

Keywords

Upper ExtremityCohort StudiesPrognosis

Outcome Measures

Primary Outcomes (3)

  • Action Research Arm Test

    Upper limb capacity

    3 months poststroke

  • Fugl-Meyer Assessment

    Upper limb motor function

    3 months poststroke

  • Motricity Index

    Upper limb motor function

    3 months poststroke

Other Outcomes (10)

  • Surface Electromyography

    48 hours, 7 days, and 3 months poststroke

  • Movement Sensors

    48 hours, 7 days, and 3 months poststroke

  • National Institutes of Health Stroke Scale

    48 hours, 7 days, and 3 months poststroke

  • +7 more other outcomes

Study Arms (1)

Single-group study

Assessment of behavioral biometric impairments

Behavioral: Assessment of behavioral biometric impairments

Interventions

Assessment of behavioral biometric impairmentsBEHAVIORAL

Assessment of behavioral biometric impairments

Single-group study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First-ever unilateral ischemic stroke patients, admitted to hospital

You may qualify if:

  • First-ever unilateral ischemic stroke in the middle cerebral artery territory \<48 hours, confirmed by MRI-DWI and/or CT
  • Age 18 years or older
  • Able to follow one-staged commands
  • NIHSS arm score ≥1
  • Informed consent after participants' information

You may not qualify if:

  • Modified Rankin Scale score \>2 before stroke
  • Neurological or other diseases affecting the upper limb(s) before stroke
  • Intravenous line in the upper limb(s) which limits assessment
  • Contra-indications on ethical grounds
  • Expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (4)

  • Fattore G, Torbica A, Susi A, Giovanni A, Benelli G, Gozzo M, Toso V. The social and economic burden of stroke survivors in Italy: a prospective, incidence-based, multi-centre cost of illness study. BMC Neurol. 2012 Nov 14;12:137. doi: 10.1186/1471-2377-12-137.

    PMID: 23150894BACKGROUND

  • Nijland RH, van Wegen EE, Harmeling-van der Wel BC, Kwakkel G; EPOS Investigators. Presence of finger extension and shoulder abduction within 72 hours after stroke predicts functional recovery: early prediction of functional outcome after stroke: the EPOS cohort study. Stroke. 2010 Apr;41(4):745-50. doi: 10.1161/STROKEAHA.109.572065. Epub 2010 Feb 18.

    PMID: 20167916BACKGROUND

  • Stinear CM, Barber PA, Petoe M, Anwar S, Byblow WD. The PREP algorithm predicts potential for upper limb recovery after stroke. Brain. 2012 Aug;135(Pt 8):2527-35. doi: 10.1093/brain/aws146. Epub 2012 Jun 10.

    PMID: 22689909BACKGROUND

  • Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.

    PMID: 22179539BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 19, 2017

Study Start

October 15, 2017

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)