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临床试验/NCT05478577
NCT05478577已完成不适用

Clinical Features and Rehabilitation Effect for Upper Limb Recovery in Patients With Stroke: Retrospective Study

IRCCS San Camillo, Venezia, Italy1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Fugl-Meyer Assessment Upper Extremity

研究概览

简要总结

Dosage of rehabilitation therapy is a key factor in promoting motor functional recovery after stroke. To date, what is not yet known are the clinical features (e.g. the neurological profile, clinical history, motor, language and cognitive abilities), which allow the clinician to predict the recovery potential of a patient before rehabilitation, based on both the initial assessment and the various treatment pathways available in the National Health System. For these reasons, the study aims to explore clinical features and potential effect of rehabilitation dose that could influence upper limb motor recovery

详细描述

Dosage of rehabilitation therapy is a key factor in promoting motor functional recovery after stroke. Moreover, even though recent evidence has shown that cognitive abilities may support motor recovery, the relationship between cognitive-linguistic and motor skills in stroke patients is still a matter of research. Regarding the dose of intervention, in trials in which patients underwent 6 hours of rehabilitation per day, functional improvements in the upper limb reached clinically relevant levels, up to a difference of 8-11 points on the Fugl-Meyer Upper Extremity. To date, evidence of clinical (e.g. motor, cognitive-linguistic and neurological) and rehabilitation features that may influence upper limb recovery are still missing. Therefore, this study aims to retrospectively explore whether there is a relationship between clinical features and upper limb recovery after rehabilitation in stroke patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • first-ever unilateral cortical-subcortical stroke, (ischemic or haemorrhagic)
  • completed at least 4 weeks of rehabilitation
  • preserved ability or possibility to provide informed consent.

排除标准

  • cerebellar or bilateral stroke
  • unstable medical conditions;
  • diagnosis of other neurological and/or psychiatric diseases in addition to stroke;
  • traumatic brain injury;
  • not released informed consent

结局指标

主要结局

Fugl-Meyer Assessment Upper Extremity

时间窗: change from baseline up to 8 weeks

Fugl-Meyer Assessment Upper Extremity is a stroke-specific scale which assesses the upper limb motor functioning in patients with post-stroke hemiplegia. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to upper limb hemiplegia. The maximum value is 66 points, which corresponds to normal motor performance.

次要结局

  • Oxford Cognitive Screen(at baseline)
  • Modified Ashworth Scale(Change from baseline up to 8 weeks.)
  • Functional Independence Measure(Change from baseline up to 8 weeks.)
  • Box & Blocks Test(Change from baseline up to 8 weeks.)
  • Reaching Performance Scale(Change from baseline up to 8 weeks.)
  • Dose of therapy(hospitalisation period (8 weeks))

研究者

发起方
IRCCS San Camillo, Venezia, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Salvalaggio

Principal Investigator

IRCCS San Camillo, Venezia, Italy

研究点 (1)

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