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Completed

NCT Number: NCT03708016

Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients

The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: more than 18 years
  • More than 6 months post stroke
  • Functional ambulation classification (FAC) (1~4)

Exclusion criteria

  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
  • Difficult to understand experimental tasks because of extremely severe cognitive impairment
  • History of disorders involving central nervous system
  • History of psychiatric disease
  • implanted objects that would contraindicate tDCS

Treatment and study plan

Robot gait training

Device

Lokomat robot training was applied to stroke patients.

brain stimulation

Device

tDCS brain stimulation on leg motor areas was applied to stroke patients.

Primary outcomes

  1. Change in 10 meter walk test from baseline in gait speed

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    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."

Secondary outcomes

  1. Change in Berg Balance Scale from baseline in balance

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    Meserue of blance function

  2. Change in Functional ambulatory category from baseline in gait function

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    Measure of functional ambulatory category

  3. Change in Timed Up and Go test from baseline in balance

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    Measure of Timued Up and Go test in balance

  4. Change on gait function (kinematic)

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    All participants perform overground walking to assess the change of kinematic using a motion analysis.

  5. Change on gait function (kinetic)

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    All participants perform overground walking to assess the change of kinetic using a force plate

  6. Change on gait function (muslce activation)

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    All participants perform overground walking to assess the change of muscle activation using a surface EMG.

  7. Changes in motor evoked potentia

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.

  8. Changes in Brain activation of resting-state functional MRI

    Time frame: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)

    Neuroplasticity measure

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 16, 2018
Registry last updated
May 27, 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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