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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorTan Tock Seng Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Brain Computer Interface integrated HandyRehab platform (BCI-HR)

    Device

    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.

  • HandyRehab (HR)

    Device

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

  • Standard Treatment of Care

    Other intervention

    Standard Conventional Occupational Therapy

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Conventional supervised occupational therapy (CT)Sham comparator 1 intervention
Group B: HandyRehab (HR) with supervised training by OTActive comparator 2 interventions
Group C: HandyRehab integrated with BCI (BCI-HR) with supervised training by OTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

Secondary outcomes

1

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

Time frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
2

Grip Strength (kg)

Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands

Time frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
3

Box and Block Test (BBT)

Measures unilateral gross manual dexterity.

Time frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)
4

Nine Hole Peg Test (NHPT)

Measures finger dexterity in stroke patients.

Time frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

Other outcomes

1

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.

Time frame
Weeks 0 (baseline), 6 (end training), 24, 52 (follow-up)
2

Visual Analogue Scale (self-reported pain score)

Unidimensional measure of pain intensity; "0" being no pain and "10" being worst pain.

Time frame
Weeks 0 (baseline), 6 (end training), 12, 24, 52 (follow-up)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tan Tock Seng Hospital

Lead sponsor

Nanyang Technological University

Collaborator

Singapore University of Technology & Design

Collaborator

National University of Singapore

Collaborator