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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
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Zurich, Suisse, 8091
- University of Zurich
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Single-group study
Assessment of behavioral biometric impairments
|
Assessment of behavioral biometric impairments
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Action Research Arm Test
Délai: 3 months poststroke
|
Upper limb capacity
|
3 months poststroke
|
|
Fugl-Meyer Assessment
Délai: 3 months poststroke
|
Upper limb motor function
|
3 months poststroke
|
|
Motricity Index
Délai: 3 months poststroke
|
Upper limb motor function
|
3 months poststroke
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Surface Electromyography
Délai: 48 hours, 7 days, and 3 months poststroke
|
Forearm skeletal muscle electric activity
|
48 hours, 7 days, and 3 months poststroke
|
|
Movement Sensors
Délai: 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
Délai: 48 hours, 7 days, and 3 months poststroke
|
Neurological functions
|
48 hours, 7 days, and 3 months poststroke
|
|
Trunk Control Test
Délai: 48 hours, 7 days, and 3 months poststroke
|
Sitting balance
|
48 hours, 7 days, and 3 months poststroke
|
|
Functional Ambulation Categories
Délai: 48 hours, 7 days, and 3 months poststroke
|
Walking ability (independence)
|
48 hours, 7 days, and 3 months poststroke
|
|
Modified Rankin Scale
Délai: 48 hours, 7 days, and 3 months poststroke
|
Global disability
|
48 hours, 7 days, and 3 months poststroke
|
|
Motor Activity Log - 14
Délai: 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
Délai: 3 months poststroke
|
3 months poststroke
|
|
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Concomitant Movement Therapy
Délai: 48 hours, 7 days, and 3 months poststroke
|
Intensity of therapy based on charts
|
48 hours, 7 days, and 3 months poststroke
|
|
Safety
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2017-00889
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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