Quantitative Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke

Not yet recruiting

• Conditions: Stroke; Rehabilitation; Tobacco Use; Prognosis; Functional MRI; Upper Extremity Dysfunction

• Registration Number: NCT05410054
• Lead Sponsor: Fu Xing Hospital, Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-06-04
• Study First Posted: 2022-06-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Study Start: 2022-08-10
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 178

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The motion network of subacute phase with functional MRI	3 months after onset	The structural and functional connection of the motion network
The motion network of chronic phase with functional MRI	6 months after onset	The structural and functional connection of the motion network
Functional assessment at early subacute phase	1 month after onset	Action Research Arm Test
Functional assessment at subacute phase	3 months after onset	Action Research Arm Test
Correlation analysis between changes of motor function and changes of motor network	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	6 months after onset	Fugl-Meyer Assessment for Upper Limb
Functional assessment at chronic phase	6 months after onset	Action Research Arm Test
The motion network of early subacute phase with functional MRI	1 month after onset	The structural and functional connection of the motion network
Motor assessment at early subacute phase	1 month after onset	Fugl-Meyer Assessment for Upper Limb
Motor assessment at subacute phase	3 months after onset	Fugl-Meyer Assessment for Upper Limb