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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Dr Laehyun Kim
Scientific

Korea Institute of Science and Technology
5, Hwarang-ro 14-gil
Seongbuk-gu
Seoul
02792
Korea, South

ORCiD logoORCID ID 0000-0002-5769-1039
Phone +82 2-958-5587
Email dahyekim@kist.re.kr

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDevelopment of Robot-assisted Motor Rehabilitation of the Upper Limb Using Bio-signal Interface
Study objectivesThe 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) studiedStroke
InterventionIn 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 date05/12/2012
Completion date13/08/2014

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants16
Total final enrolment16
Key inclusion criteria1. First ischemic or cerebral hemorrhagic stroke, which lasted over 3 months after onset
2. Between 18 and 70 years old
Key exclusion criteria1. Intracranial metal insertion
2. Claustrophobia
3. Pacemakers
4. Prohibited from taking MRI
Date of first enrolment04/01/2013
Date of final enrolment13/08/2014

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Samsung Medical Center
81 Irwon-Ro Gangnam-gu
Seoul
02878
Korea, South

Sponsor information

Korea Institute of Science and Technology
Research organisation

5,Hwarang-ro 14-gil
Seongbuk-gu
Seoul
02878
Korea, South

Phone +82 2-958-5587
Email dlfpdls87@gmail.com
Website http://eng.kist.re.kr/kist_eng/main/
ROR logo "ROR" https://ror.org/05kzfa883

Funders

Funder type

Research organisation

Korea Institute of Science and Technology
Government organisation / Local government
Alternative name(s)
KIST
Location
Korea, South

Results and Publications

Intention to publish date30/01/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planAll 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