Actively Recruiting

Phase Not Applicable
Age: 21Years - 85Years
All Genders
NCT06076928

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

Led by Tan Tock Seng Hospital · Updated on 2025-09-09

60

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

T

Tan Tock Seng Hospital

Lead Sponsor

N

Nanyang Technological University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 85 years, males and females
  • First diagnosis of stroke (ischemic or haemorrhagic) confirmed by neurologist/neurosurgeon/CT/MRI
  • More than 16 weeks post stroke
  • Hemiplegic pattern of post-stroke weakness
  • MRC motor power of 2/5 or above for shoulder abduction and elbow flexion
  • MRC motor power of 0 to 4/5 for finger flexors and/or extensors of thumb, index, and middle fingers
  • Screening Fugl-Meyer wrist hand sub score less than 18 out of 24
  • Spasticity Modified Ashworth Scale less than 3 for thumb, index, and middle fingers
  • Able to discriminate sensation to pain between thumb and index finger
  • Hand size compatible with HandyRehab glove (length 170-200mm and width 75-85mm)
  • Able to pass BCI compatible brain state screening protocol
  • Mini Mental State Examination score above 21 out of 30
  • Able to understand simple commands and give informed consent
Not Eligible

You will not qualify if you...

  • Recurrent stroke
  • Diagnosis of neurodegenerative diseases such as Parkinson's disease, Dementia, or ALS
  • Unstable medical or neurological conditions
  • Life expectancy less than 6 months
  • End-organ renal failure on dialysis
  • Severe heart failure
  • Postural hypotension
  • History of uncontrolled sepsis
  • Epilepsy with seizures within 3 months prior to consent
  • Skin conditions that could worsen with wearable robot use (ulcers, wounds, eczema, infections)
  • Unable to tolerate upright posture or sit unaided for less than 90 minutes even with breaks
  • Severe speech difficulties (dysphasia/aphasia), severe visual neglect or blindness
  • Untreated severe depression or psychiatric illness
  • Unable to understand study requirements
  • Moderate to severe spasticity (Modified Ashworth scale 2 or more)
  • Hand or arm pain rated 5 or above on pain scale
  • Finger contractures or limited wrist/finger range of motion
  • Active fractures or arthritis with deformities
  • Severe limb ataxia or apraxia
  • Severe post-stroke hemi-anaesthesia in affected upper limb
  • Inability to detect motor imagery EEG signals for BCI
  • Skull defects affecting BCI cap fit
  • Participation in other interventional research trials
  • Resident of nursing home or overseas country limiting study attendance
  • Pregnant or breastfeeding females

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tan Tock Seng Hospital

Singapore, Singapore, Singapore, 308433

Actively Recruiting

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Research Team

L

Low Ai Mei Jaclyn

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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