Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation

Prior treatment

• Concomitant participation in other interventional research trials

Other illness

• 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:
• Severe dysphasia/aphasia, severe visual neglect/blindness, untreated severe depression, psychiatric illness, unable to understand study requirements
  • Upper limb:
• Severe post stroke hemi-anaesthesia in affected UE
  • BCI incompatibility:

Other

• Neurological
• Unable to tolerate upright posture or sit unaided for \< 90min with rest breaks
• Cognitive/behavioural/visual:
• 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
• Motor imagery EEG signals unable to be detected
• Presence of craniectomy skull defect (affecting BCI cap fit and electrode contact)
• Resident of nursing home or overseas country which may compromise attendance at research site
• Pregnant or lactating females will not be allowed to participate

• 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.