StrokeNCT04985864
Effect of Simultaneous Application of HD-tDCS and Robot-assisted Gait Training on Gait Function in Stroke Patients
A study testing Brain stimulation and Treadmill gait training in people with Stroke, run by Yun-Hee Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- Brain stimulation and Treadmill gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 19 - 79 years
- More than 3 months post stroke
- Functional ambulation classification (FAC) (1~4)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Stroke
- Being tested
- Brain stimulation, Treadmill gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain stimulationDevice
tDCS brain stimulation on leg motor areas was applied to stroke patients.
Treadmill gait trainingDevice
Lokomat robot training was applied to stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Robot gait training with brain stimulation | Experimental | Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas Receives: Device: Brain stimulation; Device: Treadmill gait training |
| Gait training with sham brain stimulation | Active comparator | Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas Receives: Device: Treadmill gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
Secondary outcomes (11)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
Changes in Brain activation of resting-state functional MRI
Measure of Neuroplasticity
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks)
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".
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
Change in Range of Motion (ROM)
Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Aug 2021
- Primary completion31 Mar 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yun-Hee Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Ybrain Inc.
- Responsible party
- Sponsor-investigator, Yun-Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985864
- Sponsor's protocol ID
- 2021-06-131
- Status last verified
- Feb 2023
- First submitted
- 19 Jul 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04985864
- Acronym / sponsor ID
- 2021-06-131
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yun-Hee KimUniversity, hospital or other
- Collaborators
- Ybrain Inc.
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot gait training with brain stimulation | Experimental | Device: Brain stimulation, Device: Treadmill gait trainingLokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas |
| Gait training with sham brain stimulation | Active comparator | Device: Treadmill gait trainingTreadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 19 - 79 years
- More than 3 months post stroke
- Functional ambulation classification (FAC) (1~4)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain stimulationtDCS brain stimulation on leg motor areas was applied to stroke patients. | Device | Robot gait training with brain stimulation |
| Treadmill gait trainingLokomat robot training was applied to stroke patients. | Device | Gait training with sham brain stimulation, Robot gait training with brain stimulation |
Primary outcome
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."
11 secondary outcomes
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)
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)
Changes in Brain activation of resting-state functional MRI
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain stimulation and Treadmill gait training in people with Stroke, run by Yun-Hee Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.