Sub-acute StrokeNCT03428659
Functional Recovery Changes in Subacute Stroke Patients
An observational study of Sub-acute Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sub-acute Stroke
- What is being tested?
- Data acquisition of functional abilities in sub-acute stroke
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2018to 31 Dec 2022
- How long will I take part?
- 6 Months
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A person who was inpatient at sub-acute stage at the Samsung Medical Center.
Who may be able to join
- at least 19 years of age hemiplegic stroke patients
- Subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset
- Functional Ambulation Category Scale (FAC) of 3 or less, 7 days of onset,
- A person who understands and voluntarily participates in this study and signs a research agreement
Who cannot join
- User of artificial heartbeat
- Patients with claustrophobia
- Patients with metal implants
- Patients who are contraindicated for other common MRI
- Patients with mild motor impairment with an FMA score of 80 or higher
- Patients whose conscious state is coma and who have no response at all
- Patients who can not independently gait with the Modified Rankin Scale (mRS) score of 4 or more before the onset of disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients
In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset
- Conditions
- Sub-acute Stroke
- Being tested
- Data acquisition of functional abilities in sub-acute stroke
- Keywords
- Motor function, Recovery, Gait, Magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data acquisition of functional abilities in sub-acute strokeOther
MRI data, motor evoked potentials, gait function and behavior data acquisition
| Study group | Role | What they receive |
|---|---|---|
| Sub-acute stroke | More than 1 week post-stroke Ischemic or hemorrhagic stroke Receives: Other: Data acquisition of functional abilities in sub-acute stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanism of recovery of motor function according to recovery of sub-acute stroke
Mechanism of recovery of motor function calculate by repeated measurement method in physical and cognitive functions data and MRI data of brain
Measured: Through study completion, an average of 6 months
Mechanism of recovery of gait function according to recovery of sub-acute stroke
Mechanism of recovery of motor function calculate by repeated measurement method in 3D motion capture system and electromyography (EMG) data and MRI data of brain
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start10 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub-acute StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428659
- Sponsor's protocol ID
- 2017-11-081
- Status last verified
- Sep 2019
- First submitted
- 4 Feb 2018
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients
- ClinicalTrials.gov ID
- NCT03428659
- Acronym / sponsor ID
- 2017-11-081
- Conditions
- Sub-acute Stroke
- Keywords
- Motor function, Recovery, Gait, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Feb 2018 (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.
In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub-acute stroke | – | Other: Data acquisition of functional abilities in sub-acute strokeMore than 1 week post-stroke Ischemic or hemorrhagic stroke |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A person who was inpatient at sub-acute stage at the Samsung Medical Center.
Key inclusion criteria (4 listed)
- at least 19 years of age hemiplegic stroke patients
- Subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset
- Functional Ambulation Category Scale (FAC) of 3 or less, 7 days of onset,
- A person who understands and voluntarily participates in this study and signs a research agreement
Key exclusion criteria (7 listed)
- User of artificial heartbeat
- Patients with claustrophobia
- Patients with metal implants
- Patients who are contraindicated for other common MRI
- Patients with mild motor impairment with an FMA score of 80 or higher
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 |
|---|---|---|
| Data acquisition of functional abilities in sub-acute strokeMRI data, motor evoked potentials, gait function and behavior data acquisition | Other | Sub-acute stroke |
Primary outcome
Mechanism of recovery of motor function according to recovery of sub-acute stroke
Time frame: Through study completion, an average of 6 months
Mechanism of recovery of motor function calculate by repeated measurement method in physical and cognitive functions data and MRI data of brain
Mechanism of recovery of gait function according to recovery of sub-acute stroke
Time frame: Through study completion, an average of 6 months
Mechanism of recovery of motor function calculate by repeated measurement method in 3D motion capture system and electromyography (EMG) data and MRI data of brain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sub-acute Stroke, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanism of recovery of motor function according to recovery of sub-acute stroke (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.