StrokeNCT01945515
Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke
A study testing tDCS and Robotic-assisted gait training in people with Stroke, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients 2. Subjects chronic stroke patients with gait impairment 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS and Robotic-assisted gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2016
- 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
- Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
- Hemiplegic patients due to unilateral lesion
- Patients in chronic stage after 6 months from stroke onset
- Patients with gait impairment (FAC <= 4)
- Adult (Age >= 18)
Who cannot join
- Unstable vital sign
- History of seizure or cranial operation
- unable to walk before stroke
- bilateral hemispheric lesions
- metalic implant (cardiac pacemaker, artificial cochlear, etc.)
- severe cognitive deficit, MMSE < 10
- severe aphasic patient who cannot communicate at all
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial
- Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients
- Subjects chronic stroke patients with gait impairment
- Methods
- Group 1: Robotic-assisted gait training with anodal tDCS (45 min)
- Group 2: Robotic-assisted gait training with sham tDCS (45 min)
- Duration of treatment: 2 weeks, 5 times a week
- Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)
tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.
Robotic-assisted gait trainingDevice
Also called Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
| Study group | Role | What they receive |
|---|---|---|
| Robot + anodal tDCS | Experimental | Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min Receives: Device: tDCS; Device: Robotic-assisted gait training |
| Robot + sham tDCS | Sham comparator | Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min Receives: Device: tDCS; Device: Robotic-assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulatory Category (FAC)
Assesses functional ambulation in patients undergoing physical therapy
Measured: Baseline
Functional Ambulatory Category (FAC)
Assesses functional ambulation in patients undergoing physical therapy
Measured: 1 day after treatment
Functional Ambulatory Category (FAC)
Assesses functional ambulation in patients undergoing physical therapy
Measured: 4 weeks after treatment
Secondary outcomes (14)
10-meter walk test
Time for walking 10 meters
Measured: Baseline
10-meter walk test
Time for walking 10 meters
Measured: 1 day after treatment
10-meter walk test
Time for walking 10 meters
Measured: 4 weeks after treatment
6-min walk test
Walking distance for 6 min
Measured: Baseline
6-min walk test
Walking distance for 6 min
Measured: 1 day after treatment
6-min walk test
Walking distance for 6 min
Measured: 4 weeks after treatment
Modified Rankin's Scale
Measured: Baseline
Modified Rankin's Scale
Measured: 1 day after treatment
Modified Rankin's Scale
Measured: 4 weeks after treatment
Fugl-Meyer assessment scale for lower extremity
Assess the function of lower extremity in stroke patients
Measured: Baseline
Fugl-Meyer assessment scale for lower extremity
Assess the function of lower extremity in stroke patients
Measured: 1 day after treatment
Fugl-Meyer assessment scale for lower extremity
Assess the function of lower extremity in stroke patients
Measured: 4 weeks after treatment
Motor evoked potential
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
Measured: Baseline
Motor evoked potential
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
Measured: 1 day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
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 Seoul National University HospitalThe 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
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung-Mo Oh, Seoul National University Hospital
- Investigators
- Byung-Mo Oh, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945515
- Sponsor's protocol ID
- Robot-tDCS-2013
- Status last verified
- Dec 2016
- First submitted
- 15 Sep 2013
- Last updated
- 20 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01945515
- Acronym / sponsor ID
- Robot-tDCS-2013
- Conditions
- Stroke
- Keywords
- Stroke, transcranial direct current stimulation, robotic rehabilitation, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- First posted
- 18 Sep 2013 (estimated)
- 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.
- Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients
- Subjects chronic stroke patients with gait impairment
- Methods
- Group 1: Robotic-assisted gait training with anodal tDCS (45 min)
- Group 2: Robotic-assisted gait training with sham tDCS (45 min)
- Duration of treatment: 2 weeks, 5 times a week
- Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot + anodal tDCS | Experimental | Device: tDCS, Device: Robotic-assisted gait trainingRobotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min |
| Robot + sham tDCS | Sham comparator | Device: tDCS, Device: Robotic-assisted gait trainingRobotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
- Hemiplegic patients due to unilateral lesion
- Patients in chronic stage after 6 months from stroke onset
- Patients with gait impairment (FAC <= 4)
- Adult (Age >= 18)
Key exclusion criteria (7 listed)
- Unstable vital sign
- History of seizure or cranial operation
- unable to walk before stroke
- bilateral hemispheric lesions
- metalic implant (cardiac pacemaker, artificial cochlear, etc.)
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 |
|---|---|---|
| tDCSAlso: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds. | Device | Robot + anodal tDCS, Robot + sham tDCS |
| Robotic-assisted gait trainingAlso: Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments | Device | Robot + anodal tDCS, Robot + sham tDCS |
Primary outcome
Functional Ambulatory Category (FAC)
Time frame: Baseline
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
Time frame: 1 day after treatment
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
Time frame: 4 weeks after treatment
Assesses functional ambulation in patients undergoing physical therapy
14 secondary outcomes
10-meter walk test
Time frame: Baseline
10-meter walk test
Time frame: 1 day after treatment
10-meter walk test
Time frame: 4 weeks after treatment
6-min walk test
Time frame: Baseline
6-min walk test
Time frame: 1 day after treatment
6-min walk test
Time frame: 4 weeks after treatment
Modified Rankin's Scale
Time frame: Baseline
Modified Rankin's Scale
Time frame: 1 day after treatment
Modified Rankin's Scale
Time frame: 4 weeks after treatment
Fugl-Meyer assessment scale for lower extremity
Time frame: Baseline
Fugl-Meyer assessment scale for lower extremity
Time frame: 1 day after treatment
Fugl-Meyer assessment scale for lower extremity
Time frame: 4 weeks after treatment
Motor evoked potential
Time frame: Baseline
Motor evoked potential
Time frame: 1 day after treatment
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 20 Dec 2016.
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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.
Byung-Mo Oh, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Robotic-assisted gait training in people with Stroke, run by Seoul National University Hospital 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 5 inclusion and 7 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 20 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
Functional Ambulatory Category (FAC) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 20 Dec 2016.