Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke
1 other identifier
interventional
40
1 country
1
Brief Summary
The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy and safety of BCI therapy over traditional rehabilitation methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Apr 2007
Typical duration for not_applicable stroke
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
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedAugust 10, 2009
August 1, 2009
2.5 years
August 6, 2009
August 7, 2009
Conditions
Outcome Measures
Primary Outcomes (3)
Motricity score for hemiplegic upper limb (shoulder abduction, elbow flexion, finger-thumb opposition
Baseline (0 months), 4, 12 and 24 weeks
Fugly Meyer motor score for upper limb (0-66)
Baseline (0 months), 4, 12 and 24 weeks
Motor Assessment Scale
Baseline (0 months), 4, 12 and 24 weeks
Secondary Outcomes (2)
Functional assessments
Baseline (0 months), 4, 12 and 24 weeks
Neuroradiological parameters
Baseline (0 months), 4, 12 and 24 weeks
Study Arms (2)
Manus
EXPERIMENTALBCI_Manus
EXPERIMENTALInterventions
12 therapy session
Eligibility Criteria
You may qualify if:
- Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic).
- Moderate to severe upper extremity (UE) weakness post stroke.
- Fugly-Meyer motor score of the upper limb \< 40.
- Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region.
- Able to give own consent and understand simple instructions and learn through practice.
- Resting brain states determined by FMRI criteria
You may not qualify if:
- Recurrent stroke.
- Previous brain surgery.
- Spasticity of Modified Ashworth scale \> 2.
- Fixed contracture of any upper limb joint
- Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy
- Upper limb pain or painful joints in upper limb.
- Severe cognitive impairment (Abbreviated Mental Test \<7/10), or severe aphasia which may affect ability to participate in training.
- History of seizures in the past 12 months.
- Severe left neglect
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Neuroscience Institutelead
- Tan Tock Seng Hospitalcollaborator
- Institue for Infocomm Research, A*Starcollaborator
Study Sites (1)
National Neuroscience Institute
Singapore, 308433, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beng Ti, Christopher Ang, MD
National Neuroscience Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 10, 2009
Study Start
April 1, 2007
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 10, 2009
Record last verified: 2009-08