Quantitative Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke

Sponsor
Fu Xing Hospital, Capital Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05410054
Collaborator
(none)
178
39.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
178 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke Based on Dynamic Connection of Motion Network
Anticipated Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
good prognosis

Patients with higher Fugl-Meyer motor function scale (upper limb part) and higher Action Research Arm Test (ARAT) score.

Other: no intervention
observational research

poor prognosis

Patients with lower Fugl-Meyer motor function scale (upper limb part) and lower Action Research Arm Test (ARAT) score.

Other: no intervention
observational research

Outcome Measures

Primary Outcome Measures

  1. Motor assessment at early subacute phase [1 month after onset]

    Fugl-Meyer Assessment for Upper Limb

  2. Motor assessment at subacute phase [3 months after onset]

    Fugl-Meyer Assessment for Upper Limb

  3. Motor assessment at chronic phase [6 months after onset]

    Fugl-Meyer Assessment for Upper Limb

  4. Functional assessment at early subacute phase [1 month after onset]

    Action Research Arm Test

  5. Functional assessment at subacute phase [3 months after onset]

    Action Research Arm Test

  6. Functional assessment at chronic phase [6 months after onset]

    Action Research Arm Test

  7. The motion network of early subacute phase with functional MRI [1 month after onset]

    The structural and functional connection of the motion network

  8. The motion network of subacute phase with functional MRI [3 months after onset]

    The structural and functional connection of the motion network

  9. The motion network of chronic phase with functional MRI [6 months after onset]

    The structural and functional connection of the motion network

  10. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fu Xing Hospital, Capital Medical University

Investigators

  • Study Director: Lirong Huo, Fu Xing Hospital, Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ran Li, Attending physician, Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier:
NCT05410054
Other Study ID Numbers:
  • 2022FXHEC-KY002
First Posted:
Jun 8, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022