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Completed

NCT Number: NCT04985864

Effect of Simultaneous Application of HD-tDCS and Robot-assisted Gait Training on Gait Function in Stroke Patients

The purpose of this study was to investigate the effects of simultaneous application of transcranial direct current stimulation (tDCS) with robotic gait training in stroke patients with gait impairment.

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 19 - 79 years
  • More than 3 months post stroke
  • Functional ambulation classification (FAC) (1~4)

Exclusion criteria

  • History of serious neurological disease other than stroke
  • Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
  • History of psychiatric disease
  • Contraindicated to tDCS

Treatment and study plan

brain stimulation

Device

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

Treadmill gait training

Device

Lokomat robot training was applied to stroke patients.

Primary outcomes

  1. Change in 10 meter walk test

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    Measurement of the time it takes a subject to walk 10m with self selected gait speed. 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 (BBS)

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    Measurement of balance function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the lowest performance. Total Score = 56.

  2. Change in Timed Up and Go test (TUG)

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.

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

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks)

    Measure of Neuroplasticity

  4. Change in Geriatric Depression Scale (GDS)

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    Measure of depression. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".

  5. Changes in motor evoked potential

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response.

  6. Change in Fugl-Meyer Assessment

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.

  7. Change in Functional ambulatory category

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    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. The higher the score, the better the walking ability.

  8. Change in Modified Bathel index (MBI)

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    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.

  9. Change in Muscle Manual Test (MMT)

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    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.

  10. Change in Range of Motion (ROM)

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.

  11. Change in Modified Ashworth Scale(MAS)

    Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)

    measures spasticity with scale from 0 to 3. 0 is no increase in muscle tone. 3 is considerable increase in muscle tone, passive movement difficult.

Sponsors and collaborators

Lead sponsor

Yun-Hee Kim

Other

Collaborators

  • Ybrain Inc.

Registry information

Official study title

A Study on Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Robotic Gait Training on Gait Function in Stroke Patients With Gait Impairment

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2021
Registry last updated
Feb 23, 2023

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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