Status:
RECRUITING
Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation
Lead Sponsor:
Tan Tock Seng Hospital
Collaborating Sponsors:
Nanyang Technological University
Singapore University of Technology & Design
Conditions:
Stroke
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
Upper extremity (UE) recovery remains a huge rehabilitation challenge with largely incomplete recovery of the upper limb post stroke. This is due to heavier priorities placed on other stroke competenc...
Detailed Description
Robot-aided therapy have shown promising results in rehabilitation recovery in stroke patients while reducing strain and effort for both the therapist and suitable patients. HandyRehab (HR) is a port...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06076928
Start Date
August 1 2024
End Date
January 1 2026
Last Update
September 9 2025
Active Locations (1)
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1
Tan Tock Seng Hospital
Singapore, Singapore, Singapore, 308433