Brain Computer Interface (BCI) Integrated Wearable Hand Robotic Glove 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

Overview

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

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.

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

Primary outcome measures

• Action Research Arm Test (ARAT) Score [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]

Secondary outcome measures (12)

• Fugl-Meyer Motor Assessment (FMA) scale [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Grip Strength (kg) [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Box and Block Test (BBT) [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Nine Hole Peg Test (NHPT) [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Self-efficacy outcomes by UPSET (upper limb self-efficacy test) [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale) [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Patient reported Outcome Measures (PROMs) using subjective scales (Likert 0-5) [Time frame: Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)]
• Montreal Cognitive Assessment (MOCA) [Time frame: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Rey Auditory Verbal Learning Test (RAVLT) [Time frame: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Trail Making Test (TMT) [Time frame: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Digit Span [Time frame: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]
• Controlled Oral Word Association Test (COWAT) [Time frame: Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Singapore · 1 center

• Tan Tock Seng Hospital — Singapore

Identifiers

NCT: NCT06076928 · DSRB 2022/00694

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗