Quantitative Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke

August 2, 2022 updated by: Ran Li, Fu Xing Hospital, Capital Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

stroke patients with upper limb motor dysfunction

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor assessment at early subacute phase
Time Frame: 1 month after onset
Fugl-Meyer Assessment for Upper Limb
1 month after onset
Motor assessment at subacute phase
Time Frame: 3 months after onset
Fugl-Meyer Assessment for Upper Limb
3 months after onset
Motor assessment at chronic phase
Time Frame: 6 months after onset
Fugl-Meyer Assessment for Upper Limb
6 months after onset
Functional assessment at early subacute phase
Time Frame: 1 month after onset
Action Research Arm Test
1 month after onset
Functional assessment at subacute phase
Time Frame: 3 months after onset
Action Research Arm Test
3 months after onset
Functional assessment at chronic phase
Time Frame: 6 months after onset
Action Research Arm Test
6 months after onset
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
1 month after onset
The motion network of subacute phase with functional MRI
Time Frame: 3 months after onset
The structural and functional connection of the motion network
3 months after onset
The motion network of chronic phase with functional MRI
Time Frame: 6 months after onset
The structural and functional connection of the motion network
6 months after onset
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
1 month after onset, 3 months after onset, 6 months after onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Xing Hospital, Capital Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 10, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022FXHEC-KY002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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