StrokeNCT04054739
Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke
A study testing Robot-assisted gait training and Treadmill gait training in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robot-assisted gait training and Treadmill gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score 3
- 3 months ≤ Onset ≤ 12 months
- Korean Mini-Mental State Examination score > 24
Who cannot join
- History of surgery of affected lower limb
- Fracture of affected lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
- Conditions
- Stroke
- Being tested
- Robot-assisted gait training, Treadmill gait training
- Keywords
- robot-assisted gait training, cortical activity, gait kinematics, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted gait trainingDevice
intervention with robot-assisted gait training
Treadmill gait trainingDevice
intervention with treadmill gait training
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted gait training | Experimental | experimental group that applied the end-effector robot-assisted gait training Receives: Device: Robot-assisted gait training |
| Treadmill gait training | Active comparator | control group that applied the treadmill gait training Receives: Device: Treadmill gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenated hemoglobin levels
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
Measured: 4 weeks from baseline
Range of motion of ankle, knee, and hip joint
ankle, knee, and hip joint motion of sagittal plane during gait
Measured: 4 weeks from baseline
Secondary outcomes (20)
oxygenated hemoglobin levels
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range of motion of ankle, knee, and hip joint
ankle, knee, and hip joint motion of sagittal plane during gait
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Berg Balance Scale
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
10m walk test
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional ambulation category
Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Falls efficacy scale
Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression inventory
21-question multiple-choice self-report inventory, one of the most widely used psychometric tests
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale
health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Dynamic gait index
a clinical tool to assess gait, balance and fall risk
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Timed up and go test
a simple test used to assess a person's mobility and requires both static and dynamic balance
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
dual task - COWAT
Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
dual task - digit span test
The digit span test is a way of measuring the storage capacity of a person's working memory.
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Electromyography of lower extremities
Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Plantar pressure
Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Spatiotemporal gait parameter data
step length, step time, swing time, double limb support time during gait
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
deoxygenated hemoglobin levels
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
total hemoglobin levels
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Balance test using force plate
Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Sep 2018
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, MS, Principal investigator, National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054739
- Sponsor's protocol ID
- NRC-2017-02-015
- Status last verified
- Feb 2020
- First submitted
- 12 Aug 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim H, Park G, Shin JH, You JH. Neuroplastic effects of end-effector robotic gait training for hemiparetic stroke: a randomised controlled trial. Sci Rep. 2020 Jul 27;10(1):12461. doi: 10.1038/s41598-020-69367-3.
PubMed 32719420
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke
- ClinicalTrials.gov ID
- NCT04054739
- Acronym / sponsor ID
- NRC-2017-02-015
- Conditions
- Stroke
- Keywords
- robot-assisted gait training, cortical activity, gait kinematics, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Aug 2019 (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.
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted gait training | Experimental | Device: Robot-assisted gait trainingexperimental group that applied the end-effector robot-assisted gait training |
| Treadmill gait training | Active comparator | Device: Treadmill gait trainingcontrol group that applied the treadmill gait training |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score 3
- 3 months ≤ Onset ≤ 12 months
- Korean Mini-Mental State Examination score > 24
Key exclusion criteria (2 listed)
- History of surgery of affected lower limb
- Fracture of affected lower limb
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 |
|---|---|---|
| Robot-assisted gait trainingintervention with robot-assisted gait training | Device | Robot-assisted gait training |
| Treadmill gait trainingintervention with treadmill gait training | Device | Treadmill gait training |
Primary outcome
oxygenated hemoglobin levels
Time frame: 4 weeks from baseline
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
Range of motion of ankle, knee, and hip joint
Time frame: 4 weeks from baseline
ankle, knee, and hip joint motion of sagittal plane during gait
20 secondary outcomes
oxygenated hemoglobin levels
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range of motion of ankle, knee, and hip joint
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Berg Balance Scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
10m walk test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional ambulation category
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Falls efficacy scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression inventory
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Dynamic gait index
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Timed up and go test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
dual task - COWAT
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
dual task - digit span test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Electromyography of lower extremities
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Plantar pressure
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Spatiotemporal gait parameter data
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
deoxygenated hemoglobin levels
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
total hemoglobin levels
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Balance test using force plate
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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 11 Feb 2020.
- Derived from this study: PubMed 32719420Kim H, Park G, Shin JH, You JH. Neuroplastic effects of end-effector robotic gait training for hemiparetic stroke: a randomised controlled trial. Sci Rep. 2020 Jul 27;10(1):12461. doi: 10.1038/s41598-020-69367-3.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
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Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
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Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
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Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
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.
Joon-Ho Shin, MS principal investigator
National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted gait training and Treadmill gait training in people with Stroke, run by National Rehabilitation Center, Seoul, Korea 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 2 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 11 Feb 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?
oxygenated hemoglobin levels (time frame: 4 weeks from baseline). 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?
On the ClinicalTrials.gov record for NCT04054739, which also lists 1 linked publication.
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 11 Feb 2020.