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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Zurich、瑞士、8091
- University of Zurich
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Single-group study
Assessment of behavioral biometric impairments
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Assessment of behavioral biometric impairments
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Action Research Arm Test
大体时间:3 months poststroke
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Upper limb capacity
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3 months poststroke
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Fugl-Meyer Assessment
大体时间:3 months poststroke
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Upper limb motor function
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3 months poststroke
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Motricity Index
大体时间:3 months poststroke
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Upper limb motor function
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3 months poststroke
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Surface Electromyography
大体时间:48 hours, 7 days, and 3 months poststroke
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Forearm skeletal muscle electric activity
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48 hours, 7 days, and 3 months poststroke
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Movement Sensors
大体时间:48 hours, 7 days, and 3 months poststroke
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Upper limb range of motion patterns
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48 hours, 7 days, and 3 months poststroke
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National Institutes of Health Stroke Scale
大体时间:48 hours, 7 days, and 3 months poststroke
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Neurological functions
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48 hours, 7 days, and 3 months poststroke
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Trunk Control Test
大体时间:48 hours, 7 days, and 3 months poststroke
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Sitting balance
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48 hours, 7 days, and 3 months poststroke
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Functional Ambulation Categories
大体时间:48 hours, 7 days, and 3 months poststroke
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Walking ability (independence)
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48 hours, 7 days, and 3 months poststroke
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Modified Rankin Scale
大体时间:48 hours, 7 days, and 3 months poststroke
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Global disability
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48 hours, 7 days, and 3 months poststroke
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Motor Activity Log - 14
大体时间:48 hours, 7 days, and 3 months poststroke
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Patient-reported daily life upper limb use
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48 hours, 7 days, and 3 months poststroke
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Global Rating of Perceived Changes
大体时间:3 months poststroke
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3 months poststroke
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Concomitant Movement Therapy
大体时间:48 hours, 7 days, and 3 months poststroke
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Intensity of therapy based on charts
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48 hours, 7 days, and 3 months poststroke
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Safety
大体时间:48 hours, 7 days, and 3 months poststroke
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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)
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48 hours, 7 days, and 3 months poststroke
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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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