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Clinical Trials/NCT05410054
NCT05410054
Not yet recruiting
Not Applicable

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

Fu Xing Hospital, Capital Medical University0 sites178 target enrollmentAugust 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Fu Xing Hospital, Capital Medical University
Enrollment
178
Primary Endpoint
The motion network of subacute phase with functional MRI
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2022
End Date
December 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fu Xing Hospital, Capital Medical University
Responsible Party
Principal Investigator
Principal Investigator

Ran Li

Attending physician

Fu Xing Hospital, Capital Medical University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

The motion network of subacute phase with functional MRI

Time Frame: 3 months after onset

The structural and functional connection of the motion network

Motor assessment at early subacute phase

Time Frame: 1 month after onset

Fugl-Meyer Assessment for Upper Limb

Motor assessment at subacute phase

Time Frame: 3 months after onset

Fugl-Meyer Assessment for Upper Limb

The motion network of chronic phase with functional MRI

Time Frame: 6 months after onset

The structural and functional connection of the motion network

Functional assessment at early subacute phase

Time Frame: 1 month after onset

Action Research Arm Test

Functional assessment at subacute phase

Time Frame: 3 months after onset

Action Research Arm Test

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

Time Frame: 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

Motor assessment at chronic phase

Time Frame: 6 months after onset

Fugl-Meyer Assessment for Upper Limb

Functional assessment at chronic phase

Time Frame: 6 months after onset

Action Research Arm Test

The motion network of early subacute phase with functional MRI

Time Frame: 1 month after onset

The structural and functional connection of the motion network

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