Clinical trial NCT03287739: Recovery of Impairments Early After Stroke
Official title: Recovery of Impairments Early After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Upper Extremity
Cohort Studies
Prognosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First-ever unilateral ischemic stroke patients, admitted to hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Action Research Arm Test
timeFrame: 3 months poststroke
measure: Fugl-Meyer Assessment
timeFrame: 3 months poststroke
measure: Motricity Index
timeFrame: 3 months poststroke
Secondary outcomes:
Other outcomes:
measure: Surface Electromyography
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: Movement Sensors
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: National Institutes of Health Stroke Scale
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: Trunk Control Test
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: Functional Ambulation Categories
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: Modified Rankin Scale
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: Motor Activity Log - 14
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: Global Rating of Perceived Changes
timeFrame: 3 months poststroke
measure: Concomitant Movement Therapy
timeFrame: 48 hours, 7 days, and 3 months poststroke
measure: Safety
timeFrame: 48 hours, 7 days, and 3 months poststroke
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.