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

Launched by TAN TOCK SENG HOSPITAL · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new rehabilitation method for people who have had a stroke and are struggling with movement in their arms or hands. The researchers are testing a special wearable robotic glove called HandyRehab, which is designed to help improve upper limb recovery. The trial aims to see how effective this glove is when combined with a brain-computer interface (BCI) that detects brain signals to assist with movement.

To participate in this trial, you must be between 21 and 85 years old and have had your first stroke at least 16 weeks ago. You should also have some ability to move your shoulder and elbow, but may have limited movement in your fingers. Participants will be required to understand and follow simple instructions. If you meet these criteria, you could help advance recovery options for stroke patients. During the trial, you'll use the robotic glove and may undergo assessments to track your progress. It's important to note that certain medical conditions and mobility issues might prevent participation, so a thorough screening will take place before enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 21-85 years, males and females
• • 2. First diagnosis of stroke (ischemic or haemorrhagic), confirmed by neurologist/neurosurgeon/CT/MRI imaging
• • 3. \> 16 weeks post stroke
• • 4. Hemiplegic pattern of post-stroke weakness
• • 5. MRC ≥ 2/5 motor power and above for shoulder abduction \& elbow flexion
• • 6. MRC 0 to 4/5 motor power and above for finger flexors \&/or extensors of thumb, index, middle fingers
• • 7. Screening Fugl-Meyer wrist hand sub score \<18/24
• • 8. Spasticity MAS \<3 for thumb, index, and middle fingers
• • 9. Able to discriminate thumb and index sensation to pain
• • 10. Hand sizes within 170-200mm (length) \&75-85mm (width), compatible with HandyRehab robotic glove
• • 11. BCI compatible brain states using a standardised screening protocol
• • 12. Able to understand simple commands with Mini Mental state examination scores MMSE \> 21/30)
• • 13. 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