StrokeNCT03632070
Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients
An observational study of Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In this study, brain imaging predictive factors related to motor recovery will be investigated. Lastly, the prediction model will be established. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Data acquisition of functional abilities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2018to 24 Aug 2020
- 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: Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine
Who may be able to join
- Adults more than 19 years
- First-ever unilateral stroke
- Ischemic subacute stroke patients
Who cannot join
- Major active neurological disease or psychiatric disease
- Metallic implants in their brain
- Hemorrhagic stroke
- Bilateral lesions
- Recurrent stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients
In this study, brain imaging predictive factors related to motor recovery will be investigated. Lastly, the prediction model will be established.
- Conditions
- Stroke
- Being tested
- Data acquisition of functional abilities
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data acquisition of functional abilitiesBehavioural
MRI data, motor evoked potentials, and behavior data acquisition
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Patients with ischemic or hemorrhagic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine Receives: Behavioral: Data acquisition of functional abilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment score at 3 months after stroke onset
Measurement of motor function of upper and lower extremities
Measured: 3 months after stroke onset]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start9 Aug 2018
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632070
- Sponsor's protocol ID
- 2018-07-168
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2018
- Last updated
- 4 Sep 2020
- Results posted
- 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients
- ClinicalTrials.gov ID
- NCT03632070
- Acronym / sponsor ID
- 2018-07-168
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 15 Aug 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 this study, brain imaging predictive factors related to motor recovery will be investigated. Lastly, the prediction model will be established.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Behavioral: Data acquisition of functional abilitiesPatients with ischemic or hemorrhagic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine
Key inclusion criteria (3 listed)
- Adults more than 19 years
- First-ever unilateral stroke
- Ischemic subacute stroke patients
Key exclusion criteria (5 listed)
- Major active neurological disease or psychiatric disease
- Metallic implants in their brain
- Hemorrhagic stroke
- Bilateral lesions
- Recurrent stroke
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 abilitiesMRI data, motor evoked potentials, and behavior data acquisition | Behavioural | Stroke |
Primary outcome
Fugl-Meyer Assessment score at 3 months after stroke onset
Time frame: 3 months after stroke onset]
Measurement of motor function of upper and lower extremities
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 4 Sep 2020.
- Individual participant dataSharing planned: No
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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 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 3 inclusion and 5 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 4 Sep 2020. 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?
Fugl-Meyer Assessment score at 3 months after stroke onset (time frame: 3 months after stroke onset]). 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 4 Sep 2020.