Recovery of Impairments Early After Stroke

Completed

• Conditions: Stroke
• Interventions: Behavioral: Assessment of behavioral biometric impairments

• Registration Number: NCT03287739
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-19
• Study Start: 2017-10-15
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single-group study	Assessment of behavioral biometric impairments	Assessment of behavioral biometric impairments

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test	3 months poststroke	Upper limb capacity
Fugl-Meyer Assessment	3 months poststroke	Upper limb motor function
Motricity Index	3 months poststroke	Upper limb motor function

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland