StrokeNCT05410054
Quantitative Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke
An observational study of Stroke and Rehabilitation; Tobacco Use, run by Fu Xing Hospital, Capital Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Rehabilitation; Tobacco Use, Upper Extremity Dysfunction
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients with upper limb motor dysfunction
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Stroke, Rehabilitation; Tobacco Use, Upper Extremity Dysfunction, Prognosis, Functional MRI
- Being tested
- no intervention
- Medical subject headings
- Stroke, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational research
| Study group | Role | What they receive |
|---|---|---|
| good prognosis | Patients with higher Fugl-Meyer motor function scale (upper limb part) and higher Action Research Arm Test (ARAT) score. Receives: Other: no intervention | |
| poor prognosis | Patients with lower Fugl-Meyer motor function scale (upper limb part) and lower Action Research Arm Test (ARAT) score. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor assessment at early subacute phase
Fugl-Meyer Assessment for Upper Limb
Measured: 1 month after onset
Motor assessment at subacute phase
Fugl-Meyer Assessment for Upper Limb
Measured: 3 months after onset
Motor assessment at chronic phase
Fugl-Meyer Assessment for Upper Limb
Measured: 6 months after onset
Functional assessment at early subacute phase
Action Research Arm Test
Measured: 1 month after onset
Functional assessment at subacute phase
Action Research Arm Test
Measured: 3 months after onset
Functional assessment at chronic phase
Action Research Arm Test
Measured: 6 months after onset
The motion network of early subacute phase with functional MRI
The structural and functional connection of the motion network
Measured: 1 month after onset
The motion network of subacute phase with functional MRI
The structural and functional connection of the motion network
Measured: 3 months after onset
The motion network of chronic phase with functional MRI
The structural and functional connection of the motion network
Measured: 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
Measured: 1 month after onset, 3 months after onset, 6 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start10 Aug 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Li, Fu Xing Hospital, Capital Medical University
- Investigators
- Lirong Huo, Study director, Fu Xing Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410054
- Sponsor's protocol ID
- 2022FXHEC-KY002
- Status last verified
- Aug 2022
- First submitted
- 23 Mar 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33218284Stinear 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.
PubMed 28143920Stinear 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.
PubMed 28920888Hoonhorst 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.
PubMed 29972088Binder 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.
PubMed 33165996Nazarova 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.
PubMed 33317414Puig 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.
PubMed 30355087Lee 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.
PubMed 31093270Xia 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.
PubMed 33707406Simpson 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.
PubMed 34319189Backhaus 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.
PubMed 34056601
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke Based on Dynamic Connection of Motion Network
- ClinicalTrials.gov ID
- NCT05410054
- Acronym / sponsor ID
- 2022FXHEC-KY002
- Conditions
- Stroke, Rehabilitation; Tobacco Use, Upper Extremity Dysfunction, Prognosis, Functional MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good prognosis | – | Other: no interventionPatients with higher Fugl-Meyer motor function scale (upper limb part) and higher Action Research Arm Test (ARAT) score. |
| poor prognosis | – | Other: no interventionPatients with lower Fugl-Meyer motor function scale (upper limb part) and lower Action Research Arm Test (ARAT) score. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients with upper limb motor dysfunction
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational research | Other | good prognosis, poor prognosis |
Primary outcome
Motor assessment at early subacute phase
Time frame: 1 month after onset
Fugl-Meyer Assessment for Upper Limb
Motor assessment at subacute phase
Time frame: 3 months after onset
Fugl-Meyer Assessment for Upper Limb
Motor assessment at chronic phase
Time frame: 6 months after onset
Fugl-Meyer Assessment for Upper Limb
Functional assessment at early subacute phase
Time frame: 1 month after onset
Action Research Arm Test
Functional assessment at subacute phase
Time frame: 3 months after onset
Action Research Arm Test
Functional assessment at chronic phase
Time frame: 6 months after onset
Action Research Arm Test
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
The motion network of subacute phase with functional MRI
Time frame: 3 months after onset
The structural and functional connection of the motion network
The motion network of chronic phase with functional MRI
Time frame: 6 months after onset
The structural and functional connection of the motion network
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 33218284Lundquist 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.
- Background: PubMed 28143920Stinear 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.
- Background: PubMed 28920888Stinear 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.
- Background: PubMed 29972088Hoonhorst 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.
- Background: PubMed 33165996Binder 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.
- Background: PubMed 33317414Nazarova 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.
- Background: PubMed 30355087Puig 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.
- Background: PubMed 31093270Lee 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.
- Background: PubMed 33707406Xia 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.
- Background: PubMed 34319189Simpson 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.
- Background: PubMed 34056601Backhaus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lirong Huo study director
Fu Xing Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Rehabilitation; Tobacco Use, run by Fu Xing Hospital, Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Li (+86 1810456890, liran817@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor assessment at early subacute phase (time frame: 1 month after onset). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410054, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.