Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06076928

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

Sponsor: Tan Tock Seng Hospital

View on ClinicalTrials.gov

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.

Official title: Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove System for Upper Limb Stroke Rehabilitation: A 3-arm Randomized Controlled Trial

Key Details

Gender

All

Age Range

21 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-01

Completion Date

2026-01

Last Updated

2025-09-09

Healthy Volunteers

Conditions

Stroke

Interventions

DEVICE

Brain Computer Interface integrated HandyRehab platform (BCI-HR)

To test the usability, safety and efficacy of an experimental prototype of a wearable hand robotic glove integrated with brain computer interface system being developed and researched.

DEVICE

HandyRehab (HR)

A wearable hand robotic glove approved by Health Sciences Authority, class I commercial device

OTHER

Standard Treatment of Care

Standard Conventional Occupational Therapy

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

Locations (1)

Tan Tock Seng Hospital

Singapore, Singapore, Singapore