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OpenTrials
Completed

NCT Number: NCT03287739

Recovery of Impairments Early After Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of behavioral biometric impairments

Behavioral

Assessment of behavioral biometric impairments

Primary outcomes

  1. Action Research Arm Test

    Time frame: 3 months poststroke

    Upper limb capacity

  2. Fugl-Meyer Assessment

    Time frame: 3 months poststroke

    Upper limb motor function

  3. Motricity Index

    Time frame: 3 months poststroke

    Upper limb motor function

Other outcomes

  1. Surface Electromyography

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Forearm skeletal muscle electric activity

  2. Movement Sensors

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Upper limb range of motion patterns

  3. National Institutes of Health Stroke Scale

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Neurological functions

  4. Trunk Control Test

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Sitting balance

  5. Functional Ambulation Categories

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Walking ability (independence)

  6. Modified Rankin Scale

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Global disability

  7. Motor Activity Log - 14

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Patient-reported daily life upper limb use

  8. Global Rating of Perceived Changes

    Time frame: 3 months poststroke

  9. Concomitant Movement Therapy

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Intensity of therapy based on charts

  10. Safety

    Time frame: 48 hours, 7 days, and 3 months poststroke

    Serious 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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Acronym: aRISE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2017
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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