NCT06076928 Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation
| NCT ID | NCT06076928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tan Tock Seng Hospital |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-08-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Karen Chua
PRINCIPAL INVESTIGATOR
Tan Tock Seng Hospital
Frequently Asked Questions
Who can join the NCT06076928 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06076928 currently recruiting?
Yes, NCT06076928 is actively recruiting participants. Contact the research team at Jaclyn_AM_LOW@ttsh.com.sg for enrollment information.
Where is the NCT06076928 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06076928 clinical trial?
NCT06076928 is sponsored by Tan Tock Seng Hospital. The principal investigator is Karen Chua at Tan Tock Seng Hospital. The trial plans to enroll 60 participants.
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