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临床试验/NCT05410054
NCT05410054尚未招募不适用

The Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke Based on Dynamic Connection of Motion Network

Fu Xing Hospital, Capital Medical University0 个研究点目标入组 178 人开始时间: 2022年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
178
主要终点
Motor assessment at chronic phase

研究概览

简要总结

30% - 66% of stroke survivors have upper limb dysfunction. Effective rehabilitation can improve the prognosis, but the rehabilitation resources are limited. How to evaluate the prognosis early and formulate an individualized rehabilitation plan based on realistic expectations is still inconclusive. The current research shows that some brain network changes are related to the recovery of motor function. The dynamic connection of multi-modal and spatio-temporal fusion of motor network is helpful to the prognosis analysis of upper limb dyskinesia after stroke. 178 stroke patients will be included in this project. Fugl-Meyer motor function scale (upper limb part) and Action Research Arm Test (ARAT) will be evaluated at enrollment, 1month/3month/6month after onset. According to the results, the groups with good prognosis and poor prognosis will be distinguished; blood oxygen level dependent imaging and diffusion tensor imaging will be collected at the same time to compare the similarities and differences of the function and structural connection of the motion network; the correlation between interhemispheric connection, intrahemispheric connection, cross network connection of motor network and prognosis will be analyzed, the clinical and imaging features of different prognosis will be extracted. This study can provide scientific data support for the prognosis analysis of upper limb dysfunction after stroke, the improvement of rehabilitation clinical decision-making and the optimization of rehabilitation resource allocation.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •First stroke with upper limb motor dysfunction, Stable condition; 18 ≤age≤80 years old; The onset time was less than 3 weeks at the time of enrollment; Sign informed consent.

排除标准

  • •Stroke patients with intracranial infection, multi-system atrophy and other central nervous system diseases; Combined with severe aphasia, visual spatial neglect and other cognitive impairment; Untreated spasm (Ashworth ≥ grade 2); Obvious joint contracture restricting the movement of upper limb; In vivo metal implants; Claustrophobia.

结局指标

主要结局

Motor assessment at chronic phase

时间窗: 6 months after onset

Fugl-Meyer Assessment for Upper Limb

Functional assessment at chronic phase

时间窗: 6 months after onset

Action Research Arm Test

The motion network of early subacute phase with functional MRI

时间窗: 1 month after onset

The structural and functional connection of the motion network

The motion network of subacute phase with functional MRI

时间窗: 3 months after onset

The structural and functional connection of the motion network

Motor assessment at early subacute phase

时间窗: 1 month after onset

Fugl-Meyer Assessment for Upper Limb

Motor assessment at subacute phase

时间窗: 3 months after onset

Fugl-Meyer Assessment for Upper Limb

The motion network of chronic phase with functional MRI

时间窗: 6 months after onset

The structural and functional connection of the motion network

Functional assessment at early subacute phase

时间窗: 1 month after onset

Action Research Arm Test

Functional assessment at subacute phase

时间窗: 3 months after onset

Action Research Arm Test

Correlation analysis between changes of motor function and changes of motor network

时间窗: 1 month after onset, 3 months after onset, 6 months after onset

The correlation between interhemispheric connection, intrahemispheric connection, cross network connection of motor network and motor function prognosis will be analyzed

次要结局

未报告次要终点

研究者

发起方
Fu Xing Hospital, Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ran Li

Attending physician

Fu Xing Hospital, Capital Medical University

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