Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation
Stroke
About this trial
This is an interventional treatment trial for Stroke focused on measuring Brain Computer Interface, Hand exoskeleton robot
Eligibility Criteria
Inclusion Criteria: Age 21-85 years, males and females First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging > 16 weeks post stroke Hemiplegic pattern of post-stroke weakness MRC ≥ 2/5 motor power and above for shoulder abduction & elbow flexion MRC 0 to 4/5 motor power and above for finger flexors &/or extensors of thumb, index, middle fingers Screening Fugl-Meyer wrist hand sub score <18/24 Spasticity MAS <3 for thumb, index, and middle fingers Able to discriminate thumb and index sensation to pain Hand sizes within 170-200mm (length) &75-85mm (width), compatible with HandyRehab robotic glove BCI compatible brain states using a standardised screening protocol Able to understand simple commands with Mini Mental state examination scores MMSE > 21/30) Able to give informed consent Subjects who are unable to clear BCI screening 11. will be randomised to either CT or HR groups. Exclusion Criteria: Neurological Recurrent stroke Diagnosis of neurodegenerative disease; e.g. Parkinson's' disease, Dementia, ALS Medical: - unstable medical or neurological conditions, life expectancy <6 months, end-organ renal failure on dialysis, severe heart failure, postural hypotension, history of uncontrolled sepsis, epilepsy with seizure within 3 months of informed consent, skin conditions which could potentially be worsened by wearable robot (ulcers, open wounds, eczema, infections etc) Postural: Unable to tolerate upright posture or sit unaided for < 90min with rest breaks Cognitive/behavioural/visual: Severe dysphasia/aphasia, severe visual neglect/blindness, untreated severe depression, psychiatric illness, unable to understand study requirements Upper limb: Moderate to severe spasticity (Modified Ashworth scale MAS ≥2) Hand/arm related pain (VAS Pain ≥ 5/10), Presence of finger contractures, reduced functional range of motion, limiting functional wrist/finger movements, active fractures or arthritis with deformities Severe limb ataxia/apraxia Severe post stroke hemi-anaesthesia in affected UE BCI incompatibility: Motor imagery EEG signals unable to be detected Presence of craniectomy skull defect (affecting BCI cap fit and electrode contact) Concomitant participation in other interventional research trials Resident of nursing home or overseas country which may compromise attendance at research site Pregnant or lactating females will not be allowed to participate
Sites / Locations
- Tan Tock Seng Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Sham Comparator
Active Comparator
Experimental
Conventional supervised occupational therapy (CT)
HandyRehab (HR) with supervised training by OT
HandyRehab integrated with BCI (BCI-HR) with supervised training by OT
CT consists of standard occupational therapy for hand function which includes but not limited to the following treatment (1) passive and active mobilisation; (2) spasticity management; (3) training with use of various modalities/equipment; (4) gross and fine motor training including reach and grasp/release functions, and object manipulation; (5) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.
HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.
BCI-HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with BCI-HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip.