About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recurrent stroke
Diagnosis of neurodegenerative disease; e.g. Parkinson's' disease, Dementia, ALS
Unable to tolerate upright posture or sit unaided for < 90min with rest breaks
Severe dysphasia/aphasia, severe visual neglect/blindness, untreated severe depression, psychiatric illness, unable to understand study requirements
Trial design
Parallel
Treatments tested in this trial
Brain Computer Interface integrated HandyRehab platform (BCI-HR)
DeviceTo 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.
HandyRehab (HR)
DeviceA wearable hand robotic glove approved by Health Sciences Authority, class I commercial device
Standard Treatment of Care
Other interventionStandard Conventional Occupational Therapy
Treatment groups
Trial outcomes
Primary outcomes
Action Research Arm Test (ARAT) Score
Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.
Secondary outcomes
Fugl-Meyer Motor Assessment (FMA) scale
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Grip Strength (kg)
Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands
Box and Block Test (BBT)
Measures unilateral gross manual dexterity.
Nine Hole Peg Test (NHPT)
Measures finger dexterity in stroke patients.
Other outcomes
Modified Ashworth Scale (MAS)
Measures the level of spasticity at the elbow and finger flexors of proximal interphalangeal joint regions; scored from "0 to 4" with "4" indicating affected part is more spastic in flexion/extension.
Visual Analogue Scale (self-reported pain score)
Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.
Sponsors and contacts
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Tan Tock Seng Hospital
Lead sponsor
Nanyang Technological University
Collaborator
Singapore University of Technology & Design
Collaborator
National University of Singapore
Collaborator