Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients (iMove)
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ClinicalTrials.gov Identifier: NCT02325947 |
Recruitment Status :
Completed
First Posted : December 25, 2014
Last Update Posted : September 29, 2017
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Condition or disease | Intervention/treatment | Phase |
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Poststroke/CVA Paresis | Device: hand exoskeleton, brain-computer interface (BCI), Device: hand exoskeleton, sham BCI | Not Applicable |
The BCI training is based on EEG activity patterns recording during hand motor imagery. A subject sit comfortably 1m from a computer screen which presents visual instructions during the session. The robotic exoskeleton is fixed to the paretic hand. Subject visually fixate on a circle presented in the center of the screen and receive instructions from three surrounding rhomboidal arrows. Subject is given three commands instructing them to relax or imagine slow hand opening movement with the right or left hand. The "Relax" command means that the subject have to sit still and look at the center of the screen. Commands are presented randomly, each of 10 sec duration.
A visual cue provides the subject with feedback regarding the mental task recognition: the central circle turned green if the classifier recognizes the task in agreement with the given command, or remains white if the signal is not recognized. In addition to visual feedback the subject is provided with kinesthetic feedback: the exoskeleton is opening the hand when the classifier recognizes the imagery of paretic hand movement.
The EEG is registered with 30 electrodes distributed over the head in accordance with the standard international 10-20 system. EEG signals are filtered from 5-30Hz. A Bayesian approach for EEG pattern classifying is used in the system. The activity sources most relevant for BCI functioning will be identified using an independent component analysis (ICA). Classification accuracy will by measured with Cohen's kappa (Kohavi and Provost, 1998). The procedure may consist from up to three sessions, the duration of 1 session is 10 min, there are 5 min time brake between session and total duration of procedure is up to 45 min. The number of procedures - at least 10. The maximal interval between procedures is 3 days.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Health Services Research |
Official Title: | A Multicentre Randomized Single Blind Placebo Controlled Study to Assess Efficacy of Hand Exoskeleton Controlled by Motor Imagery Based BCI for Post Stroke Patients Movement Rehabilitation |
Study Start Date : | January 2015 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | September 2017 |
Arm | Intervention/treatment |
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Experimental: Study group
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
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Device: hand exoskeleton, brain-computer interface (BCI),
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
Other Name: mind-machine interface |
Sham Comparator: Placebo group
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
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Device: hand exoskeleton, sham BCI
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation) |
- Change from Baseline in hand paresis level and hand muscle spasticity [ Time Frame: Week 2 ]ARAT; Fugl-Meyer, Modified Ashworth scale
- Long-term changes from Baseline in hand paresis level and hand muscle spasticity [ Time Frame: week 4, week 12, week 24 ]ARAT; Fugl-Meyer, Modified Ashworth scale

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent
- Medical history of primary acute cerebrovascular event (ischemic or hemorrhagic stroke) at least 4 weeks before screening
- focal stroke located in a hemisphere
- post stroke hand paresis (mild to plegia according to Medical Research Council (MRC) Scale for Muscle Strength)
Exclusion Criteria:
- Montreal Cognitive Assessment (MoCA) scale < 22
- Left handedness
- Sensory aphasia
- Severe impairment of vision
- Modified Ashworth Scale (MAS) ≥ 4

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325947
Russian Federation | |
Research Center of Neurology of RAMS | |
Moscow, Russian Federation, 125367 |
Principal Investigator: | Roman Lyukmanov, MD | Russian Academy of Medical Sciences |
Responsible Party: | Roman Lyukmanov, Research scientist, Russian Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT02325947 |
Other Study ID Numbers: |
iMove |
First Posted: | December 25, 2014 Key Record Dates |
Last Update Posted: | September 29, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Post stroke hand paresis brain injury |
Muscle Weakness Paresis Nervous System Diseases Neurologic Manifestations |
Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Pathologic Processes |