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

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Brain stimulation

Treadmill gait training

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot gait training with brain stimulation

Gait training with sham brain stimulation

Arm Description

Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas

Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas

Outcomes

Primary Outcome Measures

Change in 10 meter walk test

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 Outcome Measures

Change in Berg Balance Scale (BBS)

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.

Change in Timed Up and Go test (TUG)

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.

Changes in Brain activation of resting-state functional MRI

Measure of Neuroplasticity

Change in Geriatric Depression Scale (GDS)

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

Changes in motor evoked potential

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.

Change in Fugl-Meyer Assessment

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

Change in Functional ambulatory category

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.

Change in Modified Bathel index (MBI)

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.

Change in Muscle Manual Test (MMT)

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.

Change in Range of Motion (ROM)

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

Change in Modified Ashworth Scale(MAS)

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.

Full Information

NCT ID

NCT04985864

First Posted

July 19, 2021

Last Updated

February 21, 2023

Sponsor

Yun-Hee Kim

Collaborators

Ybrain Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04985864

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

March 31, 2022 (Actual)

Study Completion Date

May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yun-Hee Kim

Collaborators

Ybrain Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Robot gait training with brain stimulation

Arm Type

Experimental

Arm Description

Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas

Arm Title

Gait training with sham brain stimulation

Arm Type

Active Comparator

Arm Description

Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas

Intervention Type

Device

Intervention Name(s)

Brain stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Treadmill gait training

Intervention Description

Lokomat robot training was applied to stroke patients.

Primary Outcome Measure Information:

Title

Change in 10 meter walk test

Description

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."

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Berg Balance Scale (BBS)

Description

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.

Time Frame

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

Title

Change in Timed Up and Go test (TUG)

Description

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.

Time Frame

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

Title

Changes in Brain activation of resting-state functional MRI

Description

Measure of Neuroplasticity

Time Frame

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

Title

Change in Geriatric Depression Scale (GDS)

Description

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

Time Frame

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

Title

Changes in motor evoked potential

Description

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.

Time Frame

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

Title

Change in Fugl-Meyer Assessment

Description

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

Time Frame

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

Title

Change in Functional ambulatory category

Description

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.

Time Frame

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

Title

Change in Modified Bathel index (MBI)

Description

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.

Time Frame

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

Title

Change in Muscle Manual Test (MMT)

Description

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.

Time Frame

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

Title

Change in Range of Motion (ROM)

Description

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

Time Frame

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

Title

Change in Modified Ashworth Scale(MAS)

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial