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Recovery of Impairments Early After Stroke

Recovery of Impairments Early After Stroke

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03287739
Acronym
aRISE
Enrollment
40
Registered
2017-09-19
Start date
2017-10-15
Completion date
2020-01-30
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Upper Extremity, Cohort Studies, Prognosis

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.

Interventions

BEHAVIORALAssessment of behavioral biometric impairments

Assessment of behavioral biometric impairments

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Action Research Arm Test3 months poststrokeUpper limb capacity
Fugl-Meyer Assessment3 months poststrokeUpper limb motor function
Motricity Index3 months poststrokeUpper limb motor function

Other

MeasureTime frameDescription
Trunk Control Test48 hours, 7 days, and 3 months poststrokeSitting balance
Functional Ambulation Categories48 hours, 7 days, and 3 months poststrokeWalking ability (independence)
Modified Rankin Scale48 hours, 7 days, and 3 months poststrokeGlobal disability
Surface Electromyography48 hours, 7 days, and 3 months poststrokeForearm skeletal muscle electric activity
Global Rating of Perceived Changes3 months poststroke
Concomitant Movement Therapy48 hours, 7 days, and 3 months poststrokeIntensity of therapy based on charts
Safety48 hours, 7 days, and 3 months poststrokeSerious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalisation; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect)
Motor Activity Log - 1448 hours, 7 days, and 3 months poststrokePatient-reported daily life upper limb use
Movement Sensors48 hours, 7 days, and 3 months poststrokeUpper limb range of motion patterns
National Institutes of Health Stroke Scale48 hours, 7 days, and 3 months poststrokeNeurological functions

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026