Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke
NCT ID: NCT01945515
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
21 participants
INTERVENTIONAL
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
2. Subjects chronic stroke patients with gait impairment
3. 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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robot + anodal tDCS
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
tDCS
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 training
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
Robot + sham tDCS
Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
tDCS
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 training
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tDCS
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 training
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Byung-Mo Oh
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Byung-Mo Oh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Robot-tDCS-2013
Identifier Type: -
Identifier Source: org_study_id