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Completed

NCT Number: NCT04054739

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Rehabilitation Center

Seoul, 142884, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of surgery of affected lower limb
  • Fracture of affected lower limb

Treatment and study plan

Robot-assisted gait training

Device

intervention with robot-assisted gait training

Treadmill gait training

Device

intervention with treadmill gait training

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. oxygenated hemoglobin levels

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

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

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

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

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

  3. Berg Balance Scale

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

    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.

  4. Fugl-Meyer Assessment

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

    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.

  5. 10m walk test

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

    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.

  6. Functional ambulation category

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

    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

  7. Falls efficacy scale

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

    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

  8. Beck depression inventory

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

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

  9. Stroke impact scale

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

    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

  10. Dynamic gait index

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

    a clinical tool to assess gait, balance and fall risk

  11. Timed up and go test

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

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

  12. modified Barthel index

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

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

  13. dual task - COWAT

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

    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.

  14. dual task - digit span test

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

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

  15. Electromyography of lower extremities

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

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

  16. Plantar pressure

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

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

  17. Spatiotemporal gait parameter data

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

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

  18. deoxygenated hemoglobin levels

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

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

  19. total hemoglobin levels

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

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

  20. Balance test using force plate

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

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

Sponsors and collaborators

Lead sponsor

National Rehabilitation Center, Seoul, Korea

Other Gov

Registry information

Official study title

Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2019
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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