Recovery of Impairments Early After Stroke

Stroke Clinical Trial

— aRISE  

Official title:

Recovery of Impairments Early After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287739
• Other study ID #: 2017-00889
• Status: Completed
• Start date: October 15, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Assessment of behavioral biometric impairments
Assessment of behavioral biometric impairments

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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. — View 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. Erratum in: Circulation. 2012 Jun 5;125(22):e1002. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surface Electromyography	Forearm skeletal muscle electric activity	48 hours, 7 days, and 3 months poststroke
Other	Movement Sensors	Upper limb range of motion patterns	48 hours, 7 days, and 3 months poststroke
Other	National Institutes of Health Stroke Scale	Neurological functions	48 hours, 7 days, and 3 months poststroke
Other	Trunk Control Test	Sitting balance	48 hours, 7 days, and 3 months poststroke
Other	Functional Ambulation Categories	Walking ability (independence)	48 hours, 7 days, and 3 months poststroke
Other	Modified Rankin Scale	Global disability	48 hours, 7 days, and 3 months poststroke
Other	Motor Activity Log - 14	Patient-reported daily life upper limb use	48 hours, 7 days, and 3 months poststroke
Other	Global Rating of Perceived Changes		3 months poststroke
Other	Concomitant Movement Therapy	Intensity of therapy based on charts	48 hours, 7 days, and 3 months poststroke
Other	Safety	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
Primary	Action Research Arm Test	Upper limb capacity	3 months poststroke
Primary	Fugl-Meyer Assessment	Upper limb motor function	3 months poststroke
Primary	Motricity Index	Upper limb motor function	3 months poststroke