ClinicalTrials.gg
CompletedNCT04054739Updated Feb 11, 2020

Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke

An interventional study of Robot-assisted gait training and Treadmill gait training in Stroke, sponsored by National Rehabilitation Center, Seoul, Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by National Rehabilitation Center, Seoul, Korea · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2018, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea — none open to participants now, none under way, none of them phase 3. Stroke · National Rehabilitation Center, Seoul, Korea.

Enrollment
10th of 19
30 · median 30
Started
2018
with 2 others
No phase
17 of 20
none open now
Registered
17th of 20
by date

Among the 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea, this one is the 10th largest by enrollment of the 19 interventional ones that give a count, is one of 3 that started in 2018, is one of 17 with no phase, and was the 17th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Open to participants now

None of the 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea is open now. The open studies under Stroke, anywhere →

Where they have run

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea as a file.
02

Study summary

Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke

03

Conditions studied

  • Stroke

Browse trials for

Keywords

  • robot-assisted gait training
  • cortical activity
  • gait kinematics
  • stroke
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Functional ambulation category score 3
  • 3 months ≤ Onset ≤ 12 months
  • Korean score > 24

Exclusion criteria

Exclusion Criteria:

  • History of surgery of affected lower limb
  • Fracture of affected lower limb
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Robot-assisted gait training

    experimental group that applied the end-effector robot-assisted gait training

    Device: Robot-assisted gait training

  • Active comparator
    Treadmill gait training

    control group that applied the treadmill gait training

    Device: Treadmill gait training

Interventions

  • DeviceRobot-assisted gait training

    intervention with robot-assisted gait training

  • DeviceTreadmill gait training

    intervention with treadmill gait training

06

What researchers measure

Primary outcomes

  1. oxygenated hemoglobin levels

    cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

    Time frame: 4 weeks from baseline

  2. Range of motion of ankle, knee, and hip joint

    ankle, knee, and hip joint motion of sagittal plane during gait

    Time frame: 4 weeks from baseline

Secondary outcomes

  1. oxygenated hemoglobin levels

    cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  2. Range of motion of ankle, knee, and hip joint

    ankle, knee, and hip joint motion of sagittal plane during gait

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  3. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  4. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  5. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  6. 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

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  7. 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

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  8. Beck depression inventory

    21-question multiple-choice self-report inventory, one of the most widely used psychometric tests

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  9. 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

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  10. Dynamic gait index

    a clinical tool to assess gait, balance and fall risk

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  11. Timed up and go test

    a simple test used to assess a person's mobility and requires both static and dynamic balance

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  12. modified Barthel index

    Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  13. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  14. dual task - digit span test

    The digit span test is a way of measuring the storage capacity of a person's working memory.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  15. Electromyography of lower extremities

    Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  16. Plantar pressure

    Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  17. Spatiotemporal gait parameter data

    step length, step time, swing time, double limb support time during gait

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  18. deoxygenated hemoglobin levels

    cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  19. total hemoglobin levels

    cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  20. Balance test using force plate

    Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

07

Study locations

1 site
  • National Rehabilitation Center
    Seoul, 142884, Korea, Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Nov 2019, 14 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 14 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2019
First posted
Aug 13, 2019
StartActual
Sep 1, 2018
Primary completionActual
Nov 30, 2019
CompletionActual
Dec 31, 2019
Last update
Feb 11, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04054739
Lead sponsor
National Rehabilitation Center, Seoul, Korea
Responsible party
Joon-Ho Shin (Team manager, National Rehabilitation Center, Seoul, Korea) — Principal investigator
First posted
Aug 13, 2019
Start date
Sep 1, 2018
Primary completion
Nov 30, 2019
Completion
Dec 31, 2019
Last update
Feb 11, 2020

Study contacts

Joon-Ho Shin, MS
principal investigator · National Rehabilitation Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion