Quantitative Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke

NCT05410054 | Unknown

• 1 other identifier: 2022FXHEC-KY002
• Study Type: observational
• Target: 178
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Rehabilitation; Tobacco Use; Upper Extremity Dysfunction; Prognosis; Functional MRI

Outcome Measures

Primary Outcomes (10)

• Motor assessment at early subacute phase

  Fugl-Meyer Assessment for Upper Limb

  1 month after onset

• Motor assessment at subacute phase

  Fugl-Meyer Assessment for Upper Limb

  3 months after onset

• Motor assessment at chronic phase

  Fugl-Meyer Assessment for Upper Limb

  6 months after onset

• Functional assessment at early subacute phase

  Action Research Arm Test

  1 month after onset

• Functional assessment at subacute phase

  Action Research Arm Test

  3 months after onset

• Functional assessment at chronic phase

  Action Research Arm Test

  6 months after onset

• The motion network of early subacute phase with functional MRI

  The structural and functional connection of the motion network

  1 month after onset

• The motion network of subacute phase with functional MRI

  The structural and functional connection of the motion network

  3 months after onset

• The motion network of chronic phase with functional MRI

  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

  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

Study Arms (2)

good prognosis

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

Other: no intervention

poor prognosis

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

Other: no intervention

Interventions

no intervention OTHER

observational research

good prognosis; poor prognosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

stroke patients with upper limb motor dysfunction

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Related Publications (11)

• Lundquist CB, Nielsen JF, Arguissain FG, Brunner IC. Accuracy of the Upper Limb Prediction Algorithm PREP2 Applied 2 Weeks Poststroke: A Prospective Longitudinal Study. Neurorehabil Neural Repair. 2021 Jan;35(1):68-78. doi: 10.1177/1545968320971763. Epub 2020 Nov 20.

  PMID: 33218284 BACKGROUND

• Stinear CM, Byblow WD, Ackerley SJ, Smith MC, Borges VM, Barber PA. Proportional Motor Recovery After Stroke: Implications for Trial Design. Stroke. 2017 Mar;48(3):795-798. doi: 10.1161/STROKEAHA.116.016020. Epub 2017 Jan 31.

  PMID: 28143920 BACKGROUND

• Stinear CM. Prediction of motor recovery after stroke: advances in biomarkers. Lancet Neurol. 2017 Oct;16(10):826-836. doi: 10.1016/S1474-4422(17)30283-1. Epub 2017 Sep 12.

  PMID: 28920888 BACKGROUND

• Hoonhorst MHJ, Nijland RHM, van den Berg PJS, Emmelot CH, Kollen BJ, Kwakkel G. Does Transcranial Magnetic Stimulation Have an Added Value to Clinical Assessment in Predicting Upper-Limb Function Very Early After Severe Stroke? Neurorehabil Neural Repair. 2018 Aug;32(8):682-690. doi: 10.1177/1545968318785044. Epub 2018 Jul 4.

  PMID: 29972088 BACKGROUND

• Binder E, Leimbach M, Pool EM, Volz LJ, Eickhoff SB, Fink GR, Grefkes C. Cortical reorganization after motor stroke: A pilot study on differences between the upper and lower limbs. Hum Brain Mapp. 2021 Mar;42(4):1013-1033. doi: 10.1002/hbm.25275. Epub 2020 Nov 9.

  PMID: 33165996 BACKGROUND

• Nazarova M, Kulikova S, Piradov MA, Limonova AS, Dobrynina LA, Konovalov RN, Novikov PA, Sehm B, Villringer A, Saltykova A, Nikulin VV. Multimodal Assessment of the Motor System in Patients With Chronic Ischemic Stroke. Stroke. 2021 Jan;52(1):241-249. doi: 10.1161/STROKEAHA.119.028832. Epub 2020 Dec 15.

  PMID: 33317414 BACKGROUND

• Puig J, Blasco G, Alberich-Bayarri A, Schlaug G, Deco G, Biarnes C, Navas-Marti M, Rivero M, Gich J, Figueras J, Torres C, Daunis-I-Estadella P, Oramas-Requejo CL, Serena J, Stinear CM, Kuceyeski A, Soriano-Mas C, Thomalla G, Essig M, Figley CR, Menon B, Demchuk A, Nael K, Wintermark M, Liebeskind DS, Pedraza S. Resting-State Functional Connectivity Magnetic Resonance Imaging and Outcome After Acute Stroke. Stroke. 2018 Oct;49(10):2353-2360. doi: 10.1161/STROKEAHA.118.021319.

  PMID: 30355087 BACKGROUND

• Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019.

  PMID: 31093270 BACKGROUND

• Xia Y, Huang G, Quan X, Qin Q, Li H, Xu C, Liang Z. Dynamic Structural and Functional Reorganizations Following Motor Stroke. Med Sci Monit. 2021 Mar 11;27:e929092. doi: 10.12659/MSM.929092.

  PMID: 33707406 BACKGROUND

• Simpson LA, Hayward KS, McPeake M, Field TS, Eng JJ. Challenges of Estimating Accurate Prevalence of Arm Weakness Early After Stroke. Neurorehabil Neural Repair. 2021 Oct;35(10):871-879. doi: 10.1177/15459683211028240. Epub 2021 Jul 28.

  PMID: 34319189 BACKGROUND

• Backhaus W, Braass H, Higgen FL, Gerloff C, Schulz R. Early parietofrontal network upregulation relates to future persistent deficits after severe stroke-a prospective cohort study. Brain Commun. 2021 May 4;3(2):fcab097. doi: 10.1093/braincomms/fcab097. eCollection 2021.

  PMID: 34056601 BACKGROUND

MeSH Terms

Conditions

Stroke; Tobacco Use

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Lirong Huo

  Fu Xing Hospital, Capital Medical University

  STUDY DIRECTOR

Central Study Contacts

Ran Li

CONTACT

+86 1810456890; liran817@sina.com

Yong Wang

CONTACT

+86-88062908; li20140821@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: June 8, 2022
• Study Start: August 10, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share