Plain English Summary
Background and study aims
In traditional motor rehabilitation training, patients practice repetitive limb movements aimed at improving motor function with the help of physical therapists. However, this training paradigm requires extensive training periods for patients and intensive labor for therapists. We aimed to build an EEG-based active engagement monitoring system that can be applied to various motor task of stroke patients.
Who can participate?
Patients aged 18 to 70 years old who have suffered their first stroke
What does the study involve?
Participants will be required to perform three simple motor tasks whilst brain activity is monitored using EEG equipment.
What are the possible benefits and risks of participating?
Benefit : contributing to research that may support the rehabilitation for the stroke in the future
Risk : No risks by executing three motor task(motor execution by themselves(Active task) or robot assist(Passive task)/ by imaging motor task (MI task)
Where is the study run from?
Samsung Medical Center, South Korea
When is the study starting and how long is it expected to run for?
January 2013 to August 2014
Who is funding the study?
The Korea Institute of Science and Technology (KIST), South Korea
Who is the main contact?
Dr Laehyun Kim
dahyekim@kist.re.kr
Trial website
Contact information
Type
Scientific
Primary contact
Dr Laehyun Kim
ORCID ID
https://orcid.org/0000-0002-5769-1039
Contact details
Korea Institute of Science and Technology
5
Hwarang-ro 14-gil
Seongbuk-gu
Seoul
02792
Korea
South
+82 2-958-5587
dahyekim@kist.re.kr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KIST 2013-009; SMC 2013-02-091
Study information
Scientific title
Development of Robot-assisted Motor Rehabilitation of the Upper Limb Using Bio-signal Interface
Acronym
Study hypothesis
The present study aimed to gauge patient engagement during rehabilitation training using an EEG-based BCI. We hypotheses that information related to motor task engagement can be extracted from distinct neural activity patterns associated with each motor task.
Ethics approval
Approved 17/10/2013, Institutional Review Board of both Korea Institute of Science and Technology (Hwarangno 14-gil 5, Seongbukgu, Seoul 02792, Republic of Korea; +82-2-958-6929; yeeun.lee@kist.re.kr), ref: KIST 2013-009
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke
Intervention
In order to obtain the characteristics of brain networks of chronic stroke patients during upper limb movements for rehabilitation, participants performed grasp movements with the affected hand by collecting their EEG signals. The haptic device in the experiment was controlled by a DSP processor, and it was synchronized with a stimulation program by FlashTM. This stimulus of haptic was connected to EEG System (sampling rate: 2048 Hz; Active-two, BiosemiTM, Amsterdam, Netherlands).
The experimental protocol included the following three motor tasks: an active task to be executed by a voluntary movement; a passive task to be executed using a robotic device; and a motor imagery task in which participants were instructed to imagine their movement without any physical movement. Each task involved 42 trials.
For each trial, participants fixed their gaze on the monitor for 2 or 3 s, after which they performed the motor task for 2 s after the visual and auditory cues. Participants maintained their grasping movement for 1 s, after which they were asked to release the handle while the robotic device returned it back to its starting position
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Brain activity measured using EEG data collected at the time of participation
2. Device data measured using the device log data collected at the time of participation
Secondary outcome measures
1. Months after stroke onset at time of participation measured using patient records
2. Diagnosis at time of participation measured using patient records
3. Arm mobility measured using the upper-FMA score at time of participation
Overall trial start date
05/12/2012
Overall trial end date
13/08/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. First ischemic or cerebral hemorrhagic stroke, which lasted over 3 months after onset
2. Between 18 and 70 years old
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
16
Total final enrolment
16
Participant exclusion criteria
1. Intracranial metal insertion
2. Claustrophobia
3. Pacemakers
4. Prohibited from taking MRI
Recruitment start date
04/01/2013
Recruitment end date
13/08/2014
Locations
Countries of recruitment
Korea, South
Trial participating centre
Samsung Medical Center
81 Irwon-Ro Gangnam-gu
Seoul
02878
Korea, South
Sponsor information
Organisation
Korea Institute of Science and Technology
Sponsor details
5,Hwarang-ro 14-gil
Seongbuk-gu
Seoul
02878
Korea
South
+82 2-958-5587
dlfpdls87@gmail.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Korea Institute of Science and Technology
Alternative name(s)
KIST
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Korea, South
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
30/01/2020
Participant level data
Other
Basic results (scientific)
Publication list
2015 protocol in https://www.ncbi.nlm.nih.gov/pubmed/25248189 (added 08/01/2020)
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26656269 (added 08/01/2020)
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26935230 (added 08/01/2020)
2017 results in https://doi.org/10.1016/j.cogsys.2017.02.001 (added 08/01/2020)