Chronic StrokeNCT03468166
Data Collection for Motor Function and Gait Pattern Analysis of Patients With Chronic Stroke
An observational study of Chronic Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In chronic stroke patients, the data for motor function and gait pattern analysis was obtained. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Chronic stroke
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Mar 2018to 19 Apr 2022
- 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: Subjects with chronic stroke who can walk outdoors
Who may be able to join
- Stroke patients with hemiplegia over 19 years old
- Ischemic or hemorrhagic stroke patients over 6 months of onset
- Functional Ambulation Category Scale with 3 or more scales and a person who can walk independently regardless of using of walking aids
- A person who understands and voluntarily participates in this study and signs a research agreement
Who cannot join
- Patients of artificial heartbeat
- Patients with claustrophobia
- Patients with intracranial metal implants
- Patients who are contraindicated for other common MRI scans
- Patients difficult to walk due to problems such as visual field defect, fracture, severe muscle paralysis, cognitive impairment
- Those who have a score of FMA score of 80 or more and have very slight motor impairment
Trial locations and contacts
1 site in 1 country.
About this study
In chronic stroke patients, the data for motor function and gait pattern analysis was obtained.
- Conditions
- Chronic Stroke
- Being tested
- Chronic stroke
- Keywords
- Motor function, Gait pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic strokeOther
The data for motor function and gait pattern analysis was obtained.
| Study group | Role | What they receive |
|---|---|---|
| Chronic stroke | The data for motor function and gait pattern analysis was obtained. Receives: Other: Chronic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis
Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph and motion analysis system.
Measured: 1 hour
Secondary outcomes (7)
Fugl-Meyer assessment for lower extremity (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
Measured: 20 minutes
The Timed Up and Go test (TUG)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: 10 minutes
10 meter walk test (10MWT)
Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."
Measured: 5 minutes
Manual Muscle Test (MMT)
Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance.
Measured: 15 minutes
Range of Motion (ROM)
Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.
Measured: 15 minutes
Functional Ambulation Classification (FAC)
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
Measured: 10 minutes
Modified Bathel index (MBI)
The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start19 Mar 2018
- Primary completion29 Mar 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Cross-sectional
- Enrolment
- 120 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
- NCT03468166
- Sponsor's protocol ID
- 2018-02-053
- Status last verified
- Sep 2019
- First submitted
- 6 Mar 2018
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Data Collection for Motor Function and Gait Pattern Analysis of Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03468166
- Acronym / sponsor ID
- 2018-02-053
- Conditions
- Chronic Stroke
- Keywords
- Motor function, Gait pattern
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 16 Mar 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 chronic stroke patients, the data for motor function and gait pattern analysis was obtained.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic stroke | – | Other: Chronic strokeThe data for motor function and gait pattern analysis was obtained. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic stroke who can walk outdoors
Key inclusion criteria (4 listed)
- Stroke patients with hemiplegia over 19 years old
- Ischemic or hemorrhagic stroke patients over 6 months of onset
- Functional Ambulation Category Scale with 3 or more scales and a person who can walk independently regardless of using of walking aids
- A person who understands and voluntarily participates in this study and signs a research agreement
Key exclusion criteria (6 listed)
- Patients of artificial heartbeat
- Patients with claustrophobia
- Patients with intracranial metal implants
- Patients who are contraindicated for other common MRI scans
- Patients difficult to walk due to problems such as visual field defect, fracture, severe muscle paralysis, cognitive impairment
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 |
|---|---|---|
| Chronic strokeThe data for motor function and gait pattern analysis was obtained. | Other | Chronic stroke |
Primary outcome
Gait analysis
Time frame: 1 hour
Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph and motion analysis system.
7 secondary outcomes
Fugl-Meyer assessment for lower extremity (FMA)
Time frame: 20 minutes
The Timed Up and Go test (TUG)
Time frame: 10 minutes
10 meter walk test (10MWT)
Time frame: 5 minutes
Manual Muscle Test (MMT)
Time frame: 15 minutes
Range of Motion (ROM)
Time frame: 15 minutes
Functional Ambulation Classification (FAC)
Time frame: 10 minutes
Modified Bathel index (MBI)
Time frame: 10 minutes
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.
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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 Chronic 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 6 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?
Gait analysis (time frame: 1 hour). 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 28 Oct 2026.