Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Sui Geok, Karen Chua, MD
- Phone Number: +(65)64506164
- Email: Karen_Chua@ttsh.com.sg
Study Locations
-
-
-
Singapore, Singapore, 308433
- Recruiting
- National Neuroscience Institute
-
Contact:
- Beng Ti, Christopher Ang, MD
- Phone Number: +65 63577191
- Email: beng_ti_ang@nni.com.sg
-
Principal Investigator:
- Beng Ti, Christopher Ang, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Manus
|
12 therapy session
Other Names:
|
|
EXPERIMENTAL: BCI_Manus
|
12 therapy session
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Motricity score for hemiplegic upper limb (shoulder abduction, elbow flexion, finger-thumb opposition
Time Frame: Baseline (0 months), 4, 12 and 24 weeks
|
Baseline (0 months), 4, 12 and 24 weeks
|
|
Fugly Meyer motor score for upper limb (0-66)
Time Frame: Baseline (0 months), 4, 12 and 24 weeks
|
Baseline (0 months), 4, 12 and 24 weeks
|
|
Motor Assessment Scale
Time Frame: Baseline (0 months), 4, 12 and 24 weeks
|
Baseline (0 months), 4, 12 and 24 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional assessments
Time Frame: Baseline (0 months), 4, 12 and 24 weeks
|
Baseline (0 months), 4, 12 and 24 weeks
|
|
Neuroradiological parameters
Time Frame: Baseline (0 months), 4, 12 and 24 weeks
|
Baseline (0 months), 4, 12 and 24 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Beng Ti, Christopher Ang, MD, National Neuroscience Institute
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- BCIStroke
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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