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

Study Overview
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Brief Summary
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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.

Detailed Description
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Robot-aided therapy have shown promising results in rehabilitation recovery in stroke patients while reducing strain and effort for both the therapist and suitable patients. HandyRehab (HR) is a portable, wearable hand robotic glove used for functional training. The integration of Brain Computer Interface (BCI) platform with HR provides an alternative way of communication or intended movement through end-effectors for stroke and potentially facilitate neuroplasticity, improving motor functions. This study aims to validate the usability of intensive training with HandyRehab (HR) compared with conventional occupational therapy (CT). Feasibility and safety of the novel BCI-HR will be examined and objective measures of clinical efficacy will be compared across all 3 platforms.

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

Conditions
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Stroke

Intervention / Treatment
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* Device: Brain Computer Interface integrated HandyRehab platform (BCI-HR)
* Device: HandyRehab (HR)
* Other: Standard Treatment of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design is a prospective, single-centre, single blinded 3-arm randomised controlled trial to compare upper extremity motor and functional outcomes and health related quality of life (HR-QOL) of 3 treatment modalities which are fully clinic-based and supervised by trained occupational therapists (OT). Participants will undergo dose matched training interventions with 1:1 allocation using single-blinded RCT.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional supervised occupational therapy (CT)<br>CT consists of standard occupational therapy for hand function which includes but not limited to the following treatment (1) passive and active mobilisation; (2) spasticity management; (3) training with use of various modalities/equipment; (4) gross and fine motor training including reach and grasp/release functions, and object manipulation; (5) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip. | Other: Standard Treatment of Care<br>* Standard Conventional Occupational Therapy<br>|
| Active Comparator: HandyRehab (HR) with supervised training by OT<br>HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip. | Device: HandyRehab (HR)<br>* A wearable hand robotic glove approved by Health Sciences Authority, class I commercial device<br>Other: Standard Treatment of Care<br>* Standard Conventional Occupational Therapy<br>|
| Experimental: HandyRehab integrated with BCI (BCI-HR) with supervised training by OT<br>BCI-HR training consists of (1) passive and active mobilisation (2) spasticity management (3) gross motor training with BCI-HR applied (4) grasp training: cylindrical, spherical, intrinsic, 2-finger pincer and 3-finger grip. | Device: Brain Computer Interface integrated HandyRehab platform (BCI-HR)<br>* 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.<br>Other: Standard Treatment of Care<br>* Standard Conventional Occupational Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 
| Grip Strength (kg) | Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 
| Box and Block Test (BBT) | Measures unilateral gross manual dexterity. | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 
| Nine Hole Peg Test (NHPT) | Measures finger dexterity in stroke patients. | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 
| Self-efficacy outcomes by UPSET (upper limb self-efficacy test) | Questionnaire to measure self-efficacy in various tasks after stroke. | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 
| Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale) | Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function. | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 
| Patient reported Outcome Measures (PROMs) using subjective scales (Likert 0-5) | Measures patient's opinion on the usability of HR and BCI-HR | Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up) | 
| Montreal Cognitive Assessment (MOCA) | Screening assessment to determine cognitive impairment. | Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up) | 
| Rey Auditory Verbal Learning Test (RAVLT) | Cognitive assessment to evaluate verbal learning and memory | Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up) | 
| Trail Making Test (TMT) | Neuropsychological test assessing visual attention and task switching. | Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up) | 
| Digit Span | Cognitive Assessment of both forward and backward variants. | Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up) | 
| Controlled Oral Word Association Test (COWAT) | Neuropsychological measure of verbal fluency. | Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Computer Interface, Hand exoskeleton robot