Self-directed upper limb rehabilitation following stroke
| ISRCTN | ISRCTN22743806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22743806 |
| Secondary identifying numbers | KIST 2013-009; SMC 2013-02-091 |
- Submission date
- 27/12/2019
- Registration date
- 09/01/2020
- Last edited
- 08/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Korea Institute of Science and Technology
5, Hwarang-ro 14-gil
Seongbuk-gu
Seoul
02792
Korea, South
 ORCID ID |
0000-0002-5769-1039 |
|---|---|
| Phone | +82 2-958-5587 |
| dahyekim@kist.re.kr |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Development of Robot-assisted Motor Rehabilitation of the Upper Limb Using Bio-signal Interface |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 05/12/2012 |
| Completion date | 13/08/2014 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. First ischemic or cerebral hemorrhagic stroke, which lasted over 3 months after onset 2. Between 18 and 70 years old |
| Key exclusion criteria | 1. Intracranial metal insertion 2. Claustrophobia 3. Pacemakers 4. Prohibited from taking MRI |
| Date of first enrolment | 04/01/2013 |
| Date of final enrolment | 13/08/2014 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Seoul
02878
Korea, South
Sponsor information
Research organisation
5,Hwarang-ro 14-gil
Seongbuk-gu
Seoul
02878
Korea, South
| Phone | +82 2-958-5587 |
|---|---|
| dlfpdls87@gmail.com | |
| Website | http://eng.kist.re.kr/kist_eng/main/ |
"ROR" |
https://ror.org/05kzfa883 |
Funders
Funder type
Research organisation
Government organisation / Local government
- Alternative name(s)
- KIST
- Location
- Korea, South
Results and Publications
| Intention to publish date | 30/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2015 | 08/01/2020 | Yes | No |
| Results article | results | 14/12/2015 | 08/01/2020 | Yes | No |
| Results article | results | 02/03/2016 | 08/01/2020 | Yes | No |
| Results article | results | 01/08/2017 | 08/01/2020 | Yes | No |
Editorial Notes
08/01/2020: Trial’s existence confirmed by Institutional Review Board of both Korea Institute of Science and Technology
