StrokeNCT03708016
Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients
A study testing Robot gait training and Brain stimulation in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robot gait training and Brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2018to 17 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: more than 18 years
- More than 6 months post stroke
- Functional ambulation classification (FAC) (1~4)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.
- Conditions
- Stroke
- Being tested
- Robot gait training, Brain stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot gait trainingDevice
Lokomat robot training was applied to stroke patients.
Brain stimulationDevice
tDCS brain stimulation on leg motor areas 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: Robot gait training; Device: Brain stimulation |
| Robot gait training without brain stimulation | Active comparator | Lokomat robot training and sham tDCS on the leg motor areas Receives: Device: Robot 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 from baseline in gait speed
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."
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Secondary outcomes (8)
Change in Berg Balance Scale from baseline in balance
Meserue of blance function
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change in Functional ambulatory category from baseline in gait function
Measure of functional ambulatory category
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change in Timed Up and Go test from baseline in balance
Measure of Timued Up and Go test in balance
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change on gait function (kinematic)
All participants perform overground walking to assess the change of kinematic using a motion analysis.
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change on gait function (kinetic)
All participants perform overground walking to assess the change of kinetic using a force plate
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Change on gait function (muslce activation)
All participants perform overground walking to assess the change of muscle activation using a surface EMG.
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Changes in motor evoked potentia
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)
Changes in Brain activation of resting-state functional MRI
Neuroplasticity measure
Measured: session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months 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 posted16 Oct 2018
- Study start18 Oct 2018
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708016
- Sponsor's protocol ID
- 2018-05-015
- Status last verified
- Mar 2020
- First submitted
- 12 Oct 2018
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT03708016
- Acronym / sponsor ID
- 2018-05-015
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 16 Oct 2018 (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 robot gait training with the noninvasive brain stimulation in stroke patients.
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: Robot gait training, Device: Brain stimulationLokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas |
| Robot gait training without brain stimulation | Active comparator | Device: Robot gait trainingLokomat robot training and sham tDCS on the leg motor areas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: more than 18 years
- More than 6 months post stroke
- Functional ambulation classification (FAC) (1~4)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Robot gait trainingLokomat robot training was applied to stroke patients. | Device | Robot gait training with brain stimulation, Robot gait training without brain stimulation |
| Brain stimulationtDCS brain stimulation on leg motor areas was applied to stroke patients. | Device | Robot gait training with brain stimulation |
Primary outcome
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."
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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 27 May 2020.
- Individual participant dataSharing planned: Undecided
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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 Robot gait training and Brain stimulation in people with Stroke, run by Samsung Medical Center 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 5 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 27 May 2020. 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 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)). 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 27 May 2020.