Clinical trial NCT05410054: Quantitative Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke
Official title: The Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke Based on Dynamic Connection of Motion Network
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Rehabilitation; Tobacco Use
Upper Extremity Dysfunction
Prognosis
Functional MRI
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stroke patients with upper limb motor dysfunction

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.


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.

Primary outcomes:
measure: Motor assessment at early subacute phase
timeFrame: 1 month after onset
measure: Motor assessment at subacute phase
timeFrame: 3 months after onset
measure: Motor assessment at chronic phase
timeFrame: 6 months after onset
measure: Functional assessment at early subacute phase
timeFrame: 1 month after onset
measure: Functional assessment at subacute phase
timeFrame: 3 months after onset
measure: Functional assessment at chronic phase
timeFrame: 6 months after onset
measure: The motion network of early subacute phase with functional MRI
timeFrame: 1 month after onset
measure: The motion network of subacute phase with functional MRI
timeFrame: 3 months after onset
measure: The motion network of chronic phase with functional MRI
timeFrame: 6 months after onset
measure: Correlation analysis between changes of motor function and changes of motor network
timeFrame: 1 month after onset, 3 months after onset, 6 months after onset
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fu Xing Hospital, Capital Medical University
name: Lirong Huo
role: STUDY_DIRECTOR
References:
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