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

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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 competencies such as mobility, activities of daily living training and home integration which results in suboptimal amounts of time spent in upper limb training post stroke. In this study the investigators plan to pilot brain computer interface (BCI) integrated wearable hand robotic glove (HandyRehab) system for upper limb stroke rehabilitation.

Key facts

Study ID

NCT06076928

Run by

Tan Tock Seng Hospital

People needed

60

Starts

2024-08-01

Expected to finish

2026-01-01

Last updated by the study team

2025-09-09

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tan Tock Seng Hospital — Singapore, Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.