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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Brain stimulation; Device: Treadmill gait training

• Registration Number: NCT04985864
• Lead Sponsor: Yun-Hee Kim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-27
• Study Start: 2021-08-01
• Study First Posted: 2021-08-02
• Primary Completion: 2022-03-31
• Study Completion: 2022-05-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot gait training with brain stimulation	Brain stimulation	Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas
Gait training with sham brain stimulation	Treadmill gait training	Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas
Robot gait training with brain stimulation	Treadmill gait training	Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas

Primary Outcome Measures

Name	Time	Method
Change in 10 meter walk test	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 Outcome Measures

Name	Time	Method
Change in Timed Up and Go test (TUG)	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.
Changes in motor evoked potential	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.
Change in Geriatric Depression Scale (GDS)	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".
Change in Fugl-Meyer Assessment	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.
Change in Functional ambulatory category	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.
Change in Modified Ashworth Scale(MAS)	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.
Changes in Brain activation of resting-state functional MRI	session 0 (initial visit); session 10 (at approximately 4 weeks)	Measure of Neuroplasticity
Change in Berg Balance Scale (BBS)	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.
Change in Muscle Manual Test (MMT)	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.
Change in Modified Bathel index (MBI)	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.
Change in Range of Motion (ROM)	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of