- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03287739
Recovery of Impairments Early After Stroke (aRISE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, 8091
- University of Zurich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Single-group study
Assessment of behavioral biometric impairments
|
Assessment of behavioral biometric impairments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Action Research Arm Test
Time Frame: 3 months poststroke
|
Upper limb capacity
|
3 months poststroke
|
Fugl-Meyer Assessment
Time Frame: 3 months poststroke
|
Upper limb motor function
|
3 months poststroke
|
Motricity Index
Time Frame: 3 months poststroke
|
Upper limb motor function
|
3 months poststroke
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surface Electromyography
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Forearm skeletal muscle electric activity
|
48 hours, 7 days, and 3 months poststroke
|
Movement Sensors
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Upper limb range of motion patterns
|
48 hours, 7 days, and 3 months poststroke
|
National Institutes of Health Stroke Scale
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Neurological functions
|
48 hours, 7 days, and 3 months poststroke
|
Trunk Control Test
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Sitting balance
|
48 hours, 7 days, and 3 months poststroke
|
Functional Ambulation Categories
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Walking ability (independence)
|
48 hours, 7 days, and 3 months poststroke
|
Modified Rankin Scale
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Global disability
|
48 hours, 7 days, and 3 months poststroke
|
Motor Activity Log - 14
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Patient-reported daily life upper limb use
|
48 hours, 7 days, and 3 months poststroke
|
Global Rating of Perceived Changes
Time Frame: 3 months poststroke
|
3 months poststroke
|
|
Concomitant Movement Therapy
Time Frame: 48 hours, 7 days, and 3 months poststroke
|
Intensity of therapy based on charts
|
48 hours, 7 days, and 3 months poststroke
|
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)
|
48 hours, 7 days, and 3 months poststroke
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-00889
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Assessment of behavioral biometric impairments
-
UNC Lineberger Comprehensive Cancer CenterTerminated
-
Institut de Sante Parasport Connecte SynergiesAssistance Publique - Hôpitaux de ParisRecruitingDisability or Chronic Disease Leading to DisablementFrance
-
National Bureau of Economic Research, Inc.University of Chicago; National Institutes of Health (NIH); National Institute... and other collaboratorsUnknown
-
Vejle HospitalOpen Patient data Explorative NetworkCompletedBreast Cancer | Shoulder Pain | Rehabilitation | Late EffectDenmark
-
Hasselt UniversityJessa Hospital; Ziekenhuis Oost-Limburg; Revalidatie & MS Centrum Overpelt; National...RecruitingStroke | Multiple SclerosisBelgium
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedDepression | Pain | Fatigue | Pseudomyxoma Peritonei | Peritoneal Carcinomatosis | Recurrent Endometrial Carcinoma | Anxiety Disorder | Ovarian Sarcoma | Recurrent Uterine Sarcoma | Recurrent Breast Cancer | Leydig Cell Tumor | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Ovarian... and other conditionsUnited States
-
University Hospital, GrenobleUnknown
-
University of VirginiaUnknownDeep Brain Stimulation | High Intensity Focused UltrasoundUnited States
-
Adhera Health, Inc.Jordi Gol i Gurina Foundation; Fundación Pública Andaluza para la gestión de...Completed
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States