Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients
iMove
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
1 other identifier
interventional
75
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton technology based on EEG patterns recognition matching to motor imagery in post-stroke patients with hand paresis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 25, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 29, 2017
September 1, 2017
2.7 years
December 8, 2014
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in hand paresis level and hand muscle spasticity
ARAT; Fugl-Meyer, Modified Ashworth scale
Week 2
Secondary Outcomes (1)
Long-term changes from Baseline in hand paresis level and hand muscle spasticity
week 4, week 12, week 24
Study Arms (2)
Study group
EXPERIMENTALHand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
Placebo group
SHAM COMPARATORHand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
Interventions
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Montreal Cognitive Assessment (MoCA) scale \< 22
- Left handedness
- Sensory aphasia
- Severe impairment of vision
- Modified Ashworth Scale (MAS) ≥ 4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Center of Neurology of RAMS
Moscow, 125367, Russia
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Lyukmanov, MD
Russian Academy of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research scientist
Study Record Dates
First Submitted
December 8, 2014
First Posted
December 25, 2014
Study Start
January 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
September 29, 2017
Record last verified: 2017-09